Study: NCT01340144

Adverse event: Failed total knee due to infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 625 at risk

Adverse event: Death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Colon cancer with liver metastases
Frequency: 2 affected / 625 at risk

Adverse event: Failed total knee due to arthrofibrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 625 at risk

Adverse event: Failed TKA due to chronic patellofemoral and mild tibiofemoral instability
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 625 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Unknown cause
Frequency: 6 affected / 625 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Cause of Death: MI
Frequency: 1 affected / 625 at risk

Adverse event: Periprosthetic fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 625 at risk

Adverse event: Death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Cerebellar tumor, esophageal cancer
Frequency: 1 affected / 625 at risk

Adverse event: Dehiscence
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 625 at risk

Adverse event: Chronic lateral patellar irritation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 625 at risk

Adverse event: Death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Bladder cancer
Frequency: 1 affected / 625 at risk

Adverse event: Death
Serious: yes
Organ System: Infections and infestations
Notes: Cause of death: sepsis
Frequency: 1 affected / 625 at risk

Adverse event: Death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Lung cancer
Frequency: 1 affected / 625 at risk

Adverse event: Death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Lung cancer
Frequency: 1 affected / 625 at risk

Adverse event: Haemarthrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 625 at risk

Adverse event: Arthrofibrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 625 at risk

Adverse event: Leg amputation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 625 at risk

Adverse event: Failed total knee due to infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 625 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Unknown cause
Frequency: 3 affected / 625 at risk

Adverse event: Death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Lung cancer
Frequency: 1 affected / 625 at risk

Adverse event: Arthrofibrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 625 at risk

Adverse event: Hip arthroplasty
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 625 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 625 at risk

Adverse event: Femoral fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Nondisplaced femoral neck fracture
Frequency: 1 affected / 625 at risk

Adverse event: Death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cause of death: Pneumonia
Frequency: 1 affected / 625 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 625 at risk

Adverse event: Failed TKA
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Failed TKA due to quadriceps tendon rupture
Frequency: 1 affected / 625 at risk

Adverse event: Carpal tunnel syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 625 at risk

Adverse event: Conralateral TKA
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 625 at risk

Adverse event: Lumbar stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 625 at risk

Adverse event: Hetrotrophic bone formation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 625 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 625 at risk

Adverse event: Peroneal nerve entrapment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 625 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 625 at risk