Study: NCT01904019

Adverse event: Prosthesis luxation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Device-related SAE
Frequency: 5 affected / 95 at risk

Adverse event: Hip arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Notes: Resolved with surgery
Frequency: 2 affected / 95 at risk

Adverse event: Anaphylactic shock
Serious: yes
Organ System: General disorders
Notes: To unknown medication, resolved with hospitalization
Frequency: 1 affected / 95 at risk

Adverse event: Intervertebral disc operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 95 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: General disorders
Notes: Resolved with hospitalization and diet
Frequency: 1 affected / 95 at risk

Adverse event: Heart arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 95 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 95 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Surgical and medical procedures
Notes: Resolved with surgery
Frequency: 1 affected / 95 at risk

Adverse event: Neck problems
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 95 at risk

Adverse event: Prostate hypertrophy
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Resolved with surgery
Frequency: 1 affected / 95 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Resolved with surgery
Frequency: 1 affected / 95 at risk

Adverse event: Cystocele
Serious: yes
Organ System: Renal and urinary disorders
Notes: Resolved with surgery
Frequency: 1 affected / 95 at risk

Adverse event: Gastric haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 95 at risk

Adverse event: Rizarthrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: In contralateral thumb, resolved with surgery
Frequency: 1 affected / 95 at risk

Adverse event: Cuff tear shoulder
Serious: yes
Organ System: Surgical and medical procedures
Notes: Resolved with surgery
Frequency: 1 affected / 95 at risk

Adverse event: Fracture of pseudoarthrosis radius
Serious: yes
Organ System: Surgical and medical procedures
Notes: Resolved with surgery
Frequency: 1 affected / 95 at risk

Adverse event: Thumb pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Device-related
Frequency: 3 affected / 95 at risk

Adverse event: Tenosynovitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: De Quervain tenosynovitis
Frequency: 11 affected / 95 at risk

Adverse event: Thumb and/or wrist pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Caused by overload; device-related therefore reported even if \<1% frequency
Frequency: 1 affected / 95 at risk

Adverse event: Carpal tunnel
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 95 at risk

Adverse event: Thumb infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 95 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: STT arthrosis and arthrosis in midcarpal and radiocarpal; device-related therefore reported even if \<1% frequency
Frequency: 1 affected / 95 at risk