Study: NCT01066936

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Death from unknown causes
Frequency: 2 affected / 20 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cut hand - hospital admission for intervenous (IV) antibiotics
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Contralateral THR secondary to osteoarthritis (OA)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Unicompartmental knee replacement secondary to OA
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Cholecystectomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dementia Alzheimer's type
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Subsidence of femoral prosthesis; revision in THR
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 20 at risk

Adverse event: Dislocation THR
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 20 at risk

Adverse event: Gastric ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Osteolysis region 1, 3-7 on radiograph
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pain on weight-bearing lower thigh
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cortical thickening region 3
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 20 at risk

Adverse event: Newly diagnosed hypoparathyroidism
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: Mild sclerosis over weight-bearing aspect of acetabulum on x-ray
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Adductor tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Hip pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Sprained Adductors
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Thigh and trochanteric pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Condensation around tip of stem on x-ray femur
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Trochanteric pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk