Study: NCT03431857

Adverse event: Revision
Serious: yes
Organ System: Surgical and medical procedures
Notes: 4 due to dislocation, 1 due to glenoid loosening after a fall, 1 due to patient's dissatisfaction because of limited mobility.
Frequency: 6 affected / 106 at risk

Adverse event: Knee arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 106 at risk

Adverse event: Lumbar surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 106 at risk

Adverse event: Shoulder surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: Other shoulder-related surgical procedures
Frequency: 6 affected / 106 at risk

Adverse event: Hip arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 106 at risk

Adverse event: Hand surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 106 at risk

Adverse event: Elbow arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 106 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Death occurred in 1 patient
Frequency: 5 affected / 106 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 106 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Cardiac disorders
Notes: Death occurred in 1 patient
Frequency: 2 affected / 106 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Death occurred in 1 patient
Frequency: 2 affected / 106 at risk

Adverse event: Urinary disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 106 at risk

Adverse event: Renal disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 106 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 106 at risk

Adverse event: Fracture thoracical vertebrae
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 106 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Death
Frequency: 1 affected / 106 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Surgery
Frequency: 1 affected / 106 at risk

Adverse event: Knee wound
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Surgery
Frequency: 1 affected / 106 at risk

Adverse event: Pubis bone fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 106 at risk

Adverse event: Stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 106 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Conservative treatment
Frequency: 1 affected / 106 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Surgery
Frequency: 1 affected / 106 at risk

Adverse event: Shoulder fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Conservative treatment
Frequency: 1 affected / 106 at risk

Adverse event: Pseudoarthritis rhizomelic
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Hospitalization, infiltrations
Frequency: 1 affected / 106 at risk

Adverse event: Neuropathy and athrosis of inferior limbs
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 106 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Surgery
Frequency: 1 affected / 106 at risk

Adverse event: Osteoporosis, fractures
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 106 at risk

Adverse event: Acromio-clavicular arthrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 106 at risk

Adverse event: Rachialgia and scapulalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 106 at risk

Adverse event: Cubital and Carpal Tunnel Syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Neurolysis
Frequency: 1 affected / 106 at risk

Adverse event: Humerocubital ostephytes
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Neurolysis
Frequency: 1 affected / 106 at risk

Adverse event: Dementia + respiratory infection
Serious: yes
Organ System: General disorders
Notes: Death
Frequency: 1 affected / 106 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Notes: Hospitalization
Frequency: 1 affected / 106 at risk

Adverse event: Stress urinary incontinence
Serious: yes
Organ System: General disorders
Notes: Surgery
Frequency: 1 affected / 106 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 106 at risk

Adverse event: Vitrectomy
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 106 at risk

Adverse event: Head wound
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 106 at risk

Adverse event: Cement effraction
Serious: yes
Organ System: Surgical and medical procedures
Notes: Surgery
Frequency: 1 affected / 106 at risk

Adverse event: Parkinson
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 106 at risk

Adverse event: Hyperalgic lumbosciatic
Serious: yes
Organ System: Nervous system disorders
Notes: Hospitalization
Frequency: 1 affected / 106 at risk

Adverse event: Joint dislocation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 106 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 106 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 106 at risk

Adverse event: Extraskeletal ossification
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 106 at risk

Adverse event: Nerve injury
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 106 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 106 at risk

Adverse event: Neck pain, paresthesia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 106 at risk

Adverse event: Limb injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Due to fall
Frequency: 1 affected / 106 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 106 at risk

Adverse event: Biceps rupture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: On previous tenodesis
Frequency: 1 affected / 106 at risk

Adverse event: Reflex sympathetic syndrom
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 106 at risk

Adverse event: Postoperative inflammation suspected
Serious: no
Organ System: Infections and infestations
Notes: Resolved with no further consequences
Frequency: 1 affected / 106 at risk

Adverse event: Acromion inflammation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 106 at risk

Adverse event: Acromial fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 106 at risk

Adverse event: Screw breakage
Serious: no
Organ System: Surgical and medical procedures
Notes: During screwing of inferior screw, the screw touched the Fukuda retractor and broke. Screw was maintained in place, and no problem occurred further.
Frequency: 1 affected / 106 at risk