Study: NCT01063751

Adverse event: Operative Site
Serious: yes
Organ System: Infections and infestations
Notes: Deep Joint Infection; Superficial Wound Infection
Frequency: 3 affected / 234 at risk

Adverse event: Operative Site
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Wound Hematoma, Deep Joint Infection; Superficial Wound Infection
Frequency: 5 affected / 234 at risk

Adverse event: Operative Site
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Acetabular Component Loosening; Femoral Component Loosening, Hip Pain, Femoral Crack Fracture
Frequency: 5 affected / 234 at risk

Adverse event: Operative Site
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Tendonitis; Bursitis; Hip Pain; Soft Tissue Trauma; Groin Pain: Neuritis; Acetabular Component Loosening
Frequency: 21 affected / 234 at risk

Adverse event: Non-Operative
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Anemia; Hemolytic Anemia
Frequency: 2 affected / 234 at risk

Adverse event: Non-Operative
Serious: yes
Organ System: Cardiac disorders
Notes: AV Block; A-FIB; NSTEMI; Abdominal Aortic Aneurysm; Angina / Acute Coronary Syndrome; Unstable Angina Pectoris; HTN; Exacerbation of CHF; CHF; Pacemaker Implant; HTN Crisis; Symptomatic Bradycardia with Hypotension; Vertigo; MI; Microcytic Anemia
Frequency: 15 affected / 234 at risk

Adverse event: Non-Operative
Serious: yes
Organ System: Eye disorders
Notes: R-Eye Retinal Detachment
Frequency: 1 affected / 234 at risk

Adverse event: Non-operative
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Ischemic Colitis; Cholecystitis; Mild Postoperative Ileus; Partial SBO; Partial Bowel Obstruction; Small Bowel Obstruction; Acute Colitis and Leukocytosis
Frequency: 5 affected / 234 at risk

Adverse event: Non-Operative
Serious: yes
Organ System: General disorders
Notes: Death (cause unspecified)
Frequency: 2 affected / 234 at risk

Adverse event: Non-Operative
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Acute Cholecystitis
Frequency: 1 affected / 234 at risk

Adverse event: Non-Operative
Serious: yes
Organ System: Infections and infestations
Notes: Pneumonia; Infection; Urinary Tract Infection; Pneumonia, Acute Exacerbation of COPD
Frequency: 4 affected / 234 at risk

Adverse event: Non-Operative
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Herniated Disk; Tibial \& Fibula Fractures, Sprained Muscle; Trauma; Lumbar Pain; Hip OA; Spinal Stenosis; Scoliosis; Herniated Nucleus Pulposus; Spondylosis; Knee OA; Lumbar/Lateral Recess Stenosis; MVC, Polytrauma; Rib Fractures; Subscap Hematoma
Frequency: 14 affected / 234 at risk

Adverse event: Non-Operative
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Breast; Colon; Osteosarcoma and Metastatic Osteosarcoma; Sarcoma; Leiomyosarcoma; Squamous Cell, Prostate; GI malignancy; Pituitary Adenoma
Frequency: 12 affected / 234 at risk

Adverse event: Non-Operative
Serious: yes
Organ System: Nervous system disorders
Notes: Neuropathy; Lower Extremity Weakness; Altered Mental Status; Headaches; Aneurysm; Disorientation and Memory Loss; Idiopathic Tremor; Encephalopathy, Cognitive Decline
Frequency: 7 affected / 234 at risk

Adverse event: Non-operative
Serious: yes
Organ System: Psychiatric disorders
Notes: Alcoholism
Frequency: 1 affected / 234 at risk

Adverse event: Non-Operative
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: COPD; Exacerbation of COPD; Anaphylactic Shock (Insect Sting)
Frequency: 4 affected / 234 at risk

Adverse event: Non-Operative
Serious: yes
Organ System: Surgical and medical procedures
Notes: Evacuation of hematoma and removal of extruded herniated nucleus pulposus and endplate cartilage.
Frequency: 1 affected / 234 at risk

Adverse event: Non-Operative
Serious: yes
Organ System: Vascular disorders
Notes: DVT; Pulmonary Embolism; Cerebrovascular Accident
Frequency: 6 affected / 234 at risk