Study: NCT01473134

Adverse event: Bearing Dislocation/Disassociation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 207 at risk

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 207 at risk

Adverse event: Contralateral Knee Replacement (UKA or TKA)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 207 at risk

Adverse event: Deep Wound Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 207 at risk

Adverse event: EENT
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 207 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 207 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 207 at risk

Adverse event: Genitourinary/Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 207 at risk

Adverse event: Hematological/Abnormal Lab
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 207 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 207 at risk

Adverse event: Musculoskeletal (Not study knee)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 207 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 207 at risk

Adverse event: Oncological
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 207 at risk

Adverse event: Other General Adverse Event
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 207 at risk

Adverse event: Other Ipsilateral Knee Related Adverse Event
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 207 at risk

Adverse event: Pain (progressive/persistent)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 207 at risk

Adverse event: Pulmonary/Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 207 at risk

Adverse event: Subsidence
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 207 at risk

Adverse event: Tibial Fracture
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 207 at risk

Adverse event: Traumatic Injury (Not study knee)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 207 at risk

Adverse event: Vascular/DVT
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 207 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 25 affected / 207 at risk

Adverse event: Clicking/Popping/Crepitus/Grinding
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 207 at risk

Adverse event: Contralateral Knee Replacement (UKA or TKA)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 207 at risk

Adverse event: Dermatological
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 207 at risk

Adverse event: EENT
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 19 affected / 207 at risk

Adverse event: Effusion/Swelling/Edema
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 31 affected / 207 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 207 at risk

Adverse event: Genitourinary/Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 13 affected / 207 at risk

Adverse event: Musculoskeletal (Not study knee)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 113 affected / 207 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 207 at risk

Adverse event: Other General Adverse Event
Serious: no
Organ System: General disorders
Frequency: 23 affected / 207 at risk

Adverse event: Other Ipsilateral Knee Related Adverse Event
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 40 affected / 207 at risk

Adverse event: Pain (progressive/persistent)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 51 affected / 207 at risk

Adverse event: Pulmonary/Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 207 at risk

Adverse event: Traumatic Injury (Not study knee)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 207 at risk

Adverse event: Traumatic Injury (Study Knee)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 16 affected / 207 at risk

Adverse event: Bearing Dislocation/Disassociation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 114 at risk

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 114 at risk

Adverse event: Cellulitis/Redness/Blistering
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 114 at risk

Adverse event: Contralateral Knee Replacement (UKA or TKA)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 114 at risk

Adverse event: EENT
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 114 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 114 at risk

Adverse event: Genitourinary/Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 114 at risk

Adverse event: Hemarthrosis/Hemarthritis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 114 at risk

Adverse event: Infection (Not study knee)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Musculoskeletal (Not study knee)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 114 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 114 at risk

Adverse event: Oncological
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 114 at risk

Adverse event: Other General Adverse Event
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 114 at risk

Adverse event: Other Ipsilateral Knee Related Adverse Event
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 114 at risk

Adverse event: Progressive Disease in Contralateral Compartment
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 114 at risk

Adverse event: Pulmonary/Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Subsidence
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 114 at risk

Adverse event: Traumatic Injury (Not study knee)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 114 at risk

Adverse event: Vascular/DVT
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 114 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 114 at risk

Adverse event: Clicking/Popping/Crepitus/Grinding
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 114 at risk

Adverse event: Contralateral Knee Replacement (UKA or TKA)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 114 at risk

Adverse event: Dermatological
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 114 at risk

Adverse event: EENT
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 16 affected / 114 at risk

Adverse event: Effusion/Swelling/Edema
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 114 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 114 at risk

Adverse event: Genitourinary/Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 114 at risk

Adverse event: Musculoskeletal (Not study knee)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 58 affected / 114 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 114 at risk

Adverse event: Other General Adverse Event
Serious: no
Organ System: General disorders
Frequency: 9 affected / 114 at risk

Adverse event: Other Ipsilateral Knee Related Adverse Event
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 114 at risk

Adverse event: Pain (progressive/persistent)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 24 affected / 114 at risk

Adverse event: Pulmonary/Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 114 at risk

Adverse event: Traumatic Injury (Not study knee)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 114 at risk

Adverse event: Traumatic Injury (Study Knee)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 114 at risk