Study: NCT03566082

Adverse event: Aseptic implant (acetabular cup) loosening right hip
Serious: yes
Organ System: Product Issues
Notes: Related to device
Frequency: 1 affected / 135 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Cervix cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Endometrial cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Goiter adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Unrelated
Frequency: 3 affected / 135 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Skin cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Basal cel carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Mesothelium cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Bronchus/lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Rectal/colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Artery sclerosis
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated
Frequency: 5 affected / 135 at risk

Adverse event: Cardiac arrhytmia
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated
Frequency: 8 affected / 135 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated
Frequency: 4 affected / 135 at risk

Adverse event: Deep vein trombosis
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Congestive heart failure descompensation
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated
Frequency: 3 affected / 135 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Insufficienty mitral valve
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Takotsubo cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Abcess
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Diverticulum intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 3 affected / 135 at risk

Adverse event: Fistel
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Gastro-intestinal bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Hernia Inguinalis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 3 affected / 135 at risk

Adverse event: Rectosigmoidoal polyp
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Gastric perforation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Abdominal pain due to dehydration
Serious: yes
Organ System: Endocrine disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Endocrine disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Acute hepatic failure
Serious: yes
Organ System: Endocrine disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Goitre
Serious: yes
Organ System: Endocrine disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Liver cirrosis
Serious: yes
Organ System: Endocrine disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Endocrine disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Blepharochalasis
Serious: yes
Organ System: Eye disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Notes: Unrelated
Frequency: 10 affected / 135 at risk

Adverse event: Degeneration
Serious: yes
Organ System: Eye disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Subluxation eye lens
Serious: yes
Organ System: Eye disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Hypokaliemia
Serious: yes
Organ System: Immune system disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Induced coma due to road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Pelvic fracture due to a fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Wound head due to a fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Wound in face
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Related to device
Frequency: 1 affected / 135 at risk

Adverse event: Alzheimer
Serious: yes
Organ System: Psychiatric disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Stress (extreme)
Serious: yes
Organ System: Psychiatric disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Swelling
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Meniscus injury
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Muscle tear
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Disc prolapse
Serious: yes
Organ System: Nervous system disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Carpal tunnel syndrome right
Serious: yes
Organ System: Nervous system disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Concussion
Serious: yes
Organ System: Nervous system disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Leuco-encefalopathy
Serious: yes
Organ System: Nervous system disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Corticosubcorticale atrophy
Serious: yes
Organ System: Nervous system disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Polyneuropathy
Serious: yes
Organ System: Nervous system disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Pain left hip due to a fall
Serious: yes
Organ System: General disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Worsening of the polyethylene liner wear + hip left side
Serious: yes
Organ System: General disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Hysterocele
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Benigne prostate hypertrophy
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Epidydimitis
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 6 affected / 135 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Emphysema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 3 affected / 135 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Pleura fluid
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Respiratory sepsis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Respiratory insuficience
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Acetabular component loosening
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 5 affected / 135 at risk

Adverse event: broken tooth
Serious: yes
Organ System: General disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 8 affected / 135 at risk

Adverse event: Contusio
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Foot operation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Hernia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 5 affected / 135 at risk

Adverse event: Impingement
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Labral tear
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 4 affected / 135 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Trigger finger
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Revision surgery
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Wound
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Folliculitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Ingrown toenail
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Correction abdominal wall
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Headache, right eye visual symptoms for unknown reason
Serious: yes
Organ System: General disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Hiccups
Serious: yes
Organ System: General disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Unrelated
Frequency: 4 affected / 135 at risk

Adverse event: Hydro-uretronetrosis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Hematurie
Serious: yes
Organ System: Renal and urinary disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Chronic Kidney failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Hydrometrose
Serious: yes
Organ System: Renal and urinary disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Subnephrotic proteinaria due to her nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Intermittent claudication
Serious: no
Organ System: Vascular disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Diverticulitis aorta
Serious: no
Organ System: Vascular disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Peripheral venous disease
Serious: no
Organ System: Vascular disorders
Notes: Unrelated
Frequency: 3 affected / 135 at risk

Adverse event: Syncope
Serious: no
Organ System: Vascular disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Aneurysma
Serious: no
Organ System: Vascular disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: AV-block Grade I
Serious: no
Organ System: Vascular disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Artery sclerosis
Serious: no
Organ System: Vascular disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Cardiac arrhytmia
Serious: no
Organ System: Vascular disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Deep vein trombosis
Serious: no
Organ System: Vascular disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Sinnus of arterial insufficiency
Serious: no
Organ System: Vascular disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: no
Organ System: Vascular disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Headache
Serious: no
Organ System: Vascular disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Multiple brain ischemia chronic
Serious: no
Organ System: Vascular disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Hemorrhagia Ex Ano
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Anal incontinence
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Anal swelling
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Hearing impairment
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Unrelated
Frequency: 4 affected / 135 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Unrelated
Frequency: 3 affected / 135 at risk

Adverse event: Tube dysfunction
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Endocrine disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Hypovitaminosis
Serious: no
Organ System: Endocrine disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Gout
Serious: no
Organ System: Endocrine disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Liver steatosis
Serious: no
Organ System: Endocrine disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Endocrine disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Cholecystalithiosis
Serious: no
Organ System: Endocrine disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Enlarged thyroid gland
Serious: no
Organ System: Endocrine disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: Unrelated
Frequency: 4 affected / 135 at risk

Adverse event: Retinal rupture
Serious: no
Organ System: Eye disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: PCO
Serious: no
Organ System: Eye disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Groin pain due to tendinopathy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Deteriorating pain in groin right hip
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Device related
Frequency: 1 affected / 135 at risk

Adverse event: Slightly higher CRP
Serious: no
Organ System: Immune system disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Rheuma
Serious: no
Organ System: Immune system disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Heterotopic ossification of hip seen on xray
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Device related
Frequency: 1 affected / 135 at risk

Adverse event: Peri-articular ossification
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 6 affected / 135 at risk

Adverse event: Worsening of peri-articular ossification
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Discomfort lateral aspect hip
Serious: no
Organ System: General disorders
Notes: Device related
Frequency: 2 affected / 135 at risk

Adverse event: Occasional mild discomfort in groin and hip
Serious: no
Organ System: General disorders
Notes: Device related
Frequency: 1 affected / 135 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Herpes
Serious: no
Organ System: Infections and infestations
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Infection surgical wound
Serious: no
Organ System: Infections and infestations
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Patient fell down
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Allergic reaction (food)
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Dementia
Serious: no
Organ System: Psychiatric disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Memory decline
Serious: no
Organ System: Psychiatric disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Bursitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Chondrocalcinosis menisci
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Elastofibroma
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Inflammation bursa iliopsoas
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Fibrostosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Impingement
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Infection tendon
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: muscular reumatism
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Muscle tear
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Menisci tears
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Tendon rupture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Symphysitis of pubis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Tendon disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Tendon disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Tendostosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Greater trochanteric pain syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Epicondylitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Greater trochanteric pain syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 3 affected / 135 at risk

Adverse event: Radicular pain in lower extremity (Ischias)
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Neuropatic pain
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Horner syndrome
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Dizziness cervical origin
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Unexplained bruising on lower left calf
Serious: no
Organ System: General disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Afonia
Serious: no
Organ System: General disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Fever and color wound right leg
Serious: no
Organ System: General disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Unexplained pain of operated hip
Serious: no
Organ System: General disorders
Notes: Device related
Frequency: 1 affected / 135 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Device related
Frequency: 1 affected / 135 at risk

Adverse event: Iliopsoas bursitis
Serious: no
Organ System: General disorders
Notes: Device related
Frequency: 1 affected / 135 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Unrelated
Frequency: 4 affected / 135 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Breast pain
Serious: no
Organ System: General disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Adverse reaction to metal debris
Serious: no
Organ System: Product Issues
Notes: Device related
Frequency: 1 affected / 135 at risk

Adverse event: Prostatitis
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Benigne prostate hypertrophy
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Epydimitis left testes
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Dyspnoe
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 3 affected / 135 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 3 affected / 135 at risk

Adverse event: Hyperventilation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 19 affected / 135 at risk

Adverse event: Capsular irritation around left hip and groin pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Cervicobrachialgie
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Chondromalacie
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Contusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 9 affected / 135 at risk

Adverse event: Intervertebral disc disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Cyst
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Dupuytren dig 5 right hand
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 4 affected / 135 at risk

Adverse event: Joint range of motion decreased
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Foot deformity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 5 affected / 135 at risk

Adverse event: Heel spur
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Lumbalgie
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 5 affected / 135 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Painful metatarsophalangeal joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 4 affected / 135 at risk

Adverse event: Ankle pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Peri-articular ossification
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 3 affected / 135 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Pins and needles left leg
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Device related
Frequency: 1 affected / 135 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 5 affected / 135 at risk

Adverse event: Spinal stenosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 3 affected / 135 at risk

Adverse event: Cervical vertebrae stenosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Greater trochanteric pain syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Device related
Frequency: 1 affected / 135 at risk

Adverse event: Active keratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Actinic keratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Dermatochalasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Actinic keratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 2 affected / 135 at risk

Adverse event: Exostosis in the heel
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Wound on left hip - along previous surgery wound
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Wound right knee and lower leg due to a fall
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Erythema due to bites of insects
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Removal birthmark nose
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Skin tear left arm due to a fall
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Cut left little finger
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Panniculitis right knee
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Wound left index finger
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Subunguaal hematoma right finger (3)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Wound nose due to a fall
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Psoriasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Seborrheic keratosis irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Keratosis actinica
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Prolonged chest pain
Serious: no
Organ System: General disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Intermittent flare ups of neck pain and right arm pain
Serious: no
Organ System: General disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Slight stiffness in right hip
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Device related
Frequency: 1 affected / 135 at risk

Adverse event: Benigne paroxysmale positionings vertigo (BPPV)
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Trochanteritis right hip
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Unrelated
Frequency: 3 affected / 135 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Ovarium cyste
Serious: no
Organ System: Renal and urinary disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Prostate hypertrophy
Serious: no
Organ System: Renal and urinary disorders
Notes: Unrelated
Frequency: 3 affected / 135 at risk

Adverse event: Haematuria (asymptomatic)
Serious: no
Organ System: Renal and urinary disorders
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Benign tumor tonsilla
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Malignant melanoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Rectal/colon cancer
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Basal cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Unrelated
Frequency: 1 affected / 135 at risk

Adverse event: Meningeoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Unrelated
Frequency: 1 affected / 135 at risk