Study: NCT00289133

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Unknown Cause
Frequency: 5 affected / 461 at risk

Adverse event: Death
Serious: yes
Organ System: Infections and infestations
Notes: Complications from Septic Shock due to Necrotic Gallbladder and Bowel
Frequency: 2 affected / 461 at risk

Adverse event: Other - Flexion Instability
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Revision of right total knee
Frequency: 1 affected / 461 at risk

Adverse event: Other - Left Hip Revision
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Underwent Total Hip Replacement after Breaking Hip
Frequency: 1 affected / 461 at risk

Adverse event: Other - Severe Low Back Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Led to Neurological Deficit
Frequency: 1 affected / 461 at risk

Adverse event: Other - Stage 4 Terminal Cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 461 at risk

Adverse event: Other - Stage 4 Cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 461 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 461 at risk

Adverse event: Loosening
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 461 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 461 at risk

Adverse event: Other-Syncope Weakness
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 461 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 461 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: General disorders
Frequency: 4 affected / 461 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 461 at risk

Adverse event: Other-Positive Nasal Culture for MRSA
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 461 at risk

Adverse event: Wound Problem
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 461 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 461 at risk

Adverse event: Central Nervous System
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 461 at risk

Adverse event: Extensor Mechanism
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 461 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 30 affected / 461 at risk

Adverse event: Other- Feeling of Instability
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 461 at risk

Adverse event: Other-Mild Limp Secondary to Stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 461 at risk

Adverse event: Other- Patella Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 461 at risk

Adverse event: Other- Patella Clunk
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 461 at risk

Adverse event: Other- Pes Bursitis; ITB syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 461 at risk

Adverse event: Other- Pesanserinus Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 461 at risk

Adverse event: Central Nervous System
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 461 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 461 at risk

Adverse event: Peripheral Nervous System
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 461 at risk

Adverse event: Respiratory System
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 461 at risk

Adverse event: Other- Itchy Red Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 461 at risk

Adverse event: Other- Skin Rash on Low Bilateral Legs
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 461 at risk

Adverse event: Wound Problem
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 461 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Surgical and medical procedures
Frequency: 10 affected / 461 at risk

Adverse event: Peri-op AE - Other
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 461 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 461 at risk

Adverse event: Thrombosis/Thrombophlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 461 at risk

Adverse event: Stiffness, Arthrofibrosis, Ankylosis, Limited Range of Motion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 461 at risk

Adverse event: Central Nervous System
Serious: no
Organ System: General disorders
Frequency: 2 affected / 461 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 15 affected / 461 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 461 at risk

Adverse event: Hematological
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 461 at risk

Adverse event: Hematological
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 461 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 461 at risk

Adverse event: Other - Radiographic subsidence of the femoral component - asymptomatic
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 461 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 461 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 461 at risk

Adverse event: Other - Atraumatic onset of right buttock pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 461 at risk

Adverse event: Haemarthrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 461 at risk

Adverse event: Other - Bilateral hand numbness and pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Carpal Tunnel Syndrome
Frequency: 1 affected / 461 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Unknown Cause
Frequency: 4 affected / 477 at risk

Adverse event: Other - Had fall and fractured left shoulder and had a concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 477 at risk

Adverse event: Other - Death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Unknown Cause
Frequency: 1 affected / 477 at risk

Adverse event: Other - Ovarian Cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 477 at risk

Adverse event: Other - Death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: From Respiratory Complications and Parkinson's Disease
Frequency: 1 affected / 477 at risk

Adverse event: Other - Death
Serious: yes
Organ System: Social circumstances
Notes: Reported Suicide
Frequency: 1 affected / 477 at risk

Adverse event: Other - Follow-up Left Knee Arthroscope
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 477 at risk

Adverse event: Other - Glioblastoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 477 at risk

Adverse event: Other - Fall Injured Quad Repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 477 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 477 at risk

Adverse event: Central Nervous System
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 477 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 477 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 477 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: General disorders
Frequency: 4 affected / 477 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 477 at risk

Adverse event: Central Nervous System
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 477 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 477 at risk

Adverse event: Wound Problem
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 477 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 477 at risk

Adverse event: Endocrine/Metabolic
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 477 at risk

Adverse event: Central Nervous System
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 477 at risk

Adverse event: Endocrine/Metabolic
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 477 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 37 affected / 477 at risk

Adverse event: Other-Follow-up right knee arthroscope
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 477 at risk

Adverse event: Other- Grade 1 Strain Medial Collateral Ligament
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 477 at risk

Adverse event: Other-Inflamed bursa over Gerdy's Tubercle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 477 at risk

Adverse event: Other- Patella Clunk
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 477 at risk

Adverse event: Other- Pesanserinus Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 477 at risk

Adverse event: Other- Pre Patellar Bursitis with Peri Patellar tenderness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 477 at risk

Adverse event: Other- Routine F/U to Bilateral knee arthroscopic debulking
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 477 at risk

Adverse event: Other- F/U Right Knee Arthroscope
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 477 at risk

Adverse event: other- Right Ankle Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 477 at risk

Adverse event: Other- Subject has continuous right knee pain (non-surgical knee)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 477 at risk

Adverse event: Other- Synovitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 477 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 477 at risk

Adverse event: Central Nervous System
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 477 at risk

Adverse event: Peripheral Nervous System
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 477 at risk

Adverse event: Respiratory System
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 477 at risk

Adverse event: Other- Dermis Contact Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 477 at risk

Adverse event: Other- Psoriasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 477 at risk

Adverse event: Other- Change in Insurance
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 477 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Surgical and medical procedures
Frequency: 10 affected / 477 at risk

Adverse event: Peri-op AE - Other
Serious: no
Organ System: Surgical and medical procedures
Frequency: 8 affected / 477 at risk

Adverse event: Pain
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 477 at risk

Adverse event: Stiffness, Arthrofibrosis, Ankylosis, Limited Range of Motion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 477 at risk

Adverse event: Other - Systemic: Voluntary Withdrawal
Serious: no
Organ System: Social circumstances
Notes: Reason not specified; Surgical Site not specified
Frequency: 1 affected / 477 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 477 at risk

Adverse event: Endocrine/Metabolic
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 477 at risk

Adverse event: Central Nervous System
Serious: no
Organ System: General disorders
Frequency: 2 affected / 477 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 17 affected / 477 at risk

Adverse event: Wound Problem
Serious: no
Organ System: General disorders
Frequency: 1 affected / 477 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 477 at risk

Adverse event: Other - Advanced Alzheimer's
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 477 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 477 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 477 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 477 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 477 at risk

Adverse event: Extensor Mechanism
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 477 at risk

Adverse event: Other - Left knee artrhoscopy
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 477 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 477 at risk

Adverse event: Haemarthrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 477 at risk

Adverse event: Other - 20 degree flexion contracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 477 at risk

Adverse event: Other - Bilateral knee pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Right knee pain greater than left knee pain; Arthroscope 2 months post-op
Frequency: 1 affected / 477 at risk

Adverse event: Other - Fell and injured quad
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 477 at risk