Study: NCT03017261

Adverse event: Stiffness of the joint
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Index Side
Frequency: 3 affected / 115 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Non-index side
Frequency: 1 affected / 115 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 115 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 115 at risk

Adverse event: Non-malignant asbestosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Due to injury
Frequency: 1 affected / 115 at risk

Adverse event: Finger Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Due to injury
Frequency: 1 affected / 115 at risk

Adverse event: Phimosis
Serious: yes
Organ System: Renal and urinary disorders
Notes: With difficulty urinating
Frequency: 1 affected / 115 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: with diverticulitis
Frequency: 1 affected / 115 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 115 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 115 at risk

Adverse event: Anal fissure
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 115 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 115 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 115 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: With neck pain
Frequency: 1 affected / 115 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 115 at risk

Adverse event: Bleeding, unrelated to surgical site/procedure
Serious: no
Organ System: Vascular disorders
Notes: Nose bleed
Frequency: 1 affected / 115 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: With shortness of breath
Frequency: 1 affected / 115 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Notes: Index Side
Frequency: 1 affected / 115 at risk

Adverse event: Delayed Wound Healing
Serious: no
Organ System: General disorders
Frequency: 2 affected / 115 at risk

Adverse event: Dental Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 115 at risk

Adverse event: Dental Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 115 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Notes: Index side
Frequency: 5 affected / 115 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Notes: Non-index side
Frequency: 1 affected / 115 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Notes: Lower Extremity
Frequency: 1 affected / 115 at risk

Adverse event: Effusion
Serious: no
Organ System: General disorders
Notes: Index Side
Frequency: 4 affected / 115 at risk

Adverse event: Exacerbation of anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 115 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Due to prescribed narcotics
Frequency: 1 affected / 115 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Due to injury
Frequency: 4 affected / 115 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 115 at risk

Adverse event: Generalised anxiety disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 115 at risk

Adverse event: Hernia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 115 at risk

Adverse event: Hip pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 115 at risk

Adverse event: Index knee pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 115 at risk

Adverse event: Index knee pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Due to injury
Frequency: 1 affected / 115 at risk

Adverse event: Insect bite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 115 at risk

Adverse event: Nasal polyps
Serious: no
Organ System: General disorders
Frequency: 1 affected / 115 at risk

Adverse event: MCL Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Due to injury
Frequency: 1 affected / 115 at risk

Adverse event: Lichen Sclerosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 115 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 115 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Non-index knee pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 115 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Index side
Frequency: 1 affected / 115 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Non-index side
Frequency: 4 affected / 115 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Cervical
Frequency: 1 affected / 115 at risk

Adverse event: Otitis media
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 115 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Surgical site
Frequency: 2 affected / 115 at risk

Adverse event: Pressure sores
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Surgical site
Frequency: 1 affected / 115 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 115 at risk

Adverse event: Retained device pins
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Surgical site
Frequency: 1 affected / 115 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Upper
Frequency: 2 affected / 115 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Seroma
Serious: no
Organ System: General disorders
Notes: Index side
Frequency: 1 affected / 115 at risk

Adverse event: Seroma
Serious: no
Organ System: General disorders
Notes: Surgical site
Frequency: 1 affected / 115 at risk

Adverse event: Systemic infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 115 at risk

Adverse event: Surgical Incision Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 115 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 115 at risk

Adverse event: Thigh pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Index side
Frequency: 1 affected / 115 at risk

Adverse event: Temporary hearing loss
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 115 at risk

Adverse event: Toe fungus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 115 at risk

Adverse event: Umbilical hernia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 115 at risk

Adverse event: Worsening of Parkinson's Disease
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 115 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 115 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 115 at risk

Adverse event: Pain (other musculoskeletal)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Gout
Frequency: 1 affected / 115 at risk

Adverse event: Pain (other musculoskeletal)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Bruise due to injury
Frequency: 1 affected / 115 at risk