Study: NCT00698867

Adverse event: Left shoulder arthroplasty due to rheumatoid arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 118 at risk

Adverse event: Infection requiring intervention
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 118 at risk

Adverse event: Humeral Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Postoperative humeral fracture
Frequency: 3 affected / 118 at risk

Adverse event: Sucutaneous Abscess
Serious: yes
Organ System: Infections and infestations
Notes: Patient developed 2 subcutaneous abscesses both requiring operative intervention. One abscess was located on the right dorsal wrist and the second was located on the plantar aspect of the right foot.
Frequency: 1 affected / 118 at risk

Adverse event: Post-op Hematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 118 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Loosening of total elbow
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 118 at risk

Adverse event: Non-elbow Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 118 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Elbow Contracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 118 at risk

Adverse event: Failed Ulnar Bushing
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 118 at risk

Adverse event: Resection of Distal Ulna
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 118 at risk

Adverse event: Fracture Near Operative Site
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 118 at risk

Adverse event: Patient Fell
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 118 at risk

Adverse event: Stitch abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 118 at risk

Adverse event: Olecranon and Triceps Deficiency
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 118 at risk

Adverse event: Road traffic accident
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 118 at risk

Adverse event: Lung neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 118 at risk

Adverse event: Bursitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 118 at risk

Adverse event: Perforation Anterior Medical Proximal Ulna
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 118 at risk

Adverse event: Ulnar Neuropathy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 118 at risk

Adverse event: Foreign Body Reaction/Excision Olecranon Mass
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 118 at risk

Adverse event: Elbow Squeaking
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 118 at risk

Adverse event: MCP Replacement
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 118 at risk

Adverse event: Coagulase Negative Staph Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 118 at risk

Adverse event: Posterior Screw Backing Out
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 118 at risk

Adverse event: Humeral radiolucency
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 118 at risk

Adverse event: Humeral Component Loosening
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 118 at risk

Adverse event: Posterior Nerve Palsy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 118 at risk

Adverse event: Painful Lateral Elbow
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 118 at risk

Adverse event: Leukaemia
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 118 at risk

Adverse event: Wound drainage
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 118 at risk

Adverse event: Olecranon Impingement
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 118 at risk

Adverse event: Insidious Onset Edema Elbow
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 118 at risk

Adverse event: Ectopic Bone Formation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 118 at risk

Adverse event: Elbow Contracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 118 at risk