Study: NCT00764504

Adverse event: Anemia / Bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 156 at risk

Adverse event: Broken Device / Component
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 156 at risk

Adverse event: Broken Screw
Serious: no
Organ System: Surgical and medical procedures
Notes: screws are used to secure parts of the device to bone and will occasionally break.
Frequency: 9 affected / 156 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Immune system disorders
Frequency: 5 affected / 156 at risk

Adverse event: Death - Natural Causes
Serious: no
Organ System: Social circumstances
Frequency: 9 affected / 156 at risk

Adverse event: Device Instability / Failure
Serious: no
Organ System: Surgical and medical procedures
Notes: Device became unstable or failed which required a revision surgery.
Frequency: 11 affected / 156 at risk

Adverse event: Joint dislocation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 156 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 156 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 156 at risk

Adverse event: Heart Complications
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 156 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 156 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 57 affected / 156 at risk

Adverse event: Neurological disorder and numbness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 156 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 156 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 156 at risk

Adverse event: Swelling
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 156 at risk

Adverse event: Anemia / Bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 162 at risk

Adverse event: Broken Device / Component
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 162 at risk

Adverse event: Broken Screw
Serious: no
Organ System: Surgical and medical procedures
Notes: screws are used to secure parts of the device to bone and will occasionally break.
Frequency: 3 affected / 162 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 162 at risk

Adverse event: Death - Natural Causes
Serious: no
Organ System: Social circumstances
Frequency: 5 affected / 162 at risk

Adverse event: Device Instability / Failure
Serious: no
Organ System: Surgical and medical procedures
Notes: Device became unstable or failed which required a revision surgery.
Frequency: 16 affected / 162 at risk

Adverse event: Joint dislocation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 162 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 162 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 162 at risk

Adverse event: Heart Complications
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 162 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 162 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 47 affected / 162 at risk

Adverse event: Neurological disorder and numbness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 162 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 162 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 162 at risk

Adverse event: Swelling
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 162 at risk

Adverse event: Broken Screw
Serious: no
Organ System: Surgical and medical procedures
Notes: screws are used to secure parts of the device to bone and will occasionally break.
Frequency: 2 affected / 249 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Immune system disorders
Frequency: 5 affected / 249 at risk

Adverse event: Death - Natural Causes
Serious: no
Organ System: Social circumstances
Frequency: 13 affected / 249 at risk

Adverse event: Device Instability / Failure
Serious: no
Organ System: Surgical and medical procedures
Notes: Device became unstable or failed which required a revision surgery.
Frequency: 8 affected / 249 at risk

Adverse event: Joint dislocation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 249 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 249 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 249 at risk

Adverse event: Heart Complications
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 249 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 249 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 68 affected / 249 at risk

Adverse event: Neurological disorder and numbness
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 249 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 249 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 249 at risk

Adverse event: Swelling
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 249 at risk