Study: NCT01481896

Adverse event: Component Revision
Serious: yes
Organ System: Surgical and medical procedures
Notes: Loose stem revised at 3.0 years; Broken stem revised at 4.6 years; Metal liner \& head revised at 8.5 years for femoral osteolysis, groin pain, metallosis and implant corrosion; Broken stem with metal liner \& head revised at 9.6 years with corrosion
Frequency: 4 affected / 131 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Patients died 3 days, 6.5 years, 7.8 years and 8.0 years after their hip replacements at ages of 77.3, 53.9, 82.0 and 72.2 respectively. Death at 3 days thought to be due to a sudden cardiac event.
Frequency: 4 affected / 126 at risk

Adverse event: Irrigation & Debridement for Hematoma
Serious: yes
Organ System: Surgical and medical procedures
Notes: After a hip aspiration to rule out infection 12 days post-operatively, patient presented with severe pain 14 days post-operatively and approximately 500 cc of dense hematoma was removed during a hip exploration.
Frequency: 1 affected / 131 at risk

Adverse event: Irrigation & Debridement for Infection
Serious: yes
Organ System: Surgical and medical procedures
Notes: Patient presented with increasing pain, fever and a wound that had begun to drain slightly serous fluid. An incision and drainage for acute infection was performed 0.05 years post-operatively. Intra-operatively cultures grew Staphylococcus aureus.
Frequency: 1 affected / 131 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Surgical and medical procedures
Notes: Patient sustained a dislocation 5.5 years post-operatively that was reduced in the Emergency Room.
Frequency: 1 affected / 131 at risk

Adverse event: Post-operative Fat Embolism
Serious: yes
Organ System: Vascular disorders
Notes: Patient developed a decrease in metal status along with hypoxia and decreased blood pressure during the evening after surgery and was thought to have had a fat embolism or a reaction to post-operative medications.
Frequency: 1 affected / 131 at risk

Adverse event: Serum Metal Levels of 7 micrograms/L or higher
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: At a mean follow-up of 4.5 years (range 1.0-6.3), 6 patients had cobalt or chromium levels of at least 7 based on results from community labs. Among these 6, median cobalt level was 26 (range 4.8-37) and median chromium level was 7.4 (range 2.9-28.9)
Frequency: 6 affected / 65 at risk

Adverse event: Femoral osteolysis on x-ray
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Three patients had osteolysis confined to the proximal femur that was identified on routine follow-up x-rays taken at 5.0, 5.5, and 5.6-year follow-up.
Frequency: 3 affected / 108 at risk

Adverse event: Pelvic osteolysis on computed tomography scan
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Two patients had pelvic osteolysis identified at the cup rim on computed tomography scans. One had a 2.7 cubic centimeter inferior rim defect at 5.1 year follow-up. The other had 7.4 cubic centimeter anterior rim defect at 5.2 year follow-up.
Frequency: 2 affected / 38 at risk

Adverse event: Loose stem on x-ray
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: A loose stem was identified on a routine follow-up x-ray taken at 5.1-year follow-up.
Frequency: 1 affected / 108 at risk

Adverse event: Hip Subluxation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient reported a subluxation that occurred 2.6 years post-operatively and self-reduced.
Frequency: 1 affected / 131 at risk

Adverse event: Greater Trochanter Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: One patient had an asymptomatic fracture on a 6-week follow-up radiograph that was not treated. Another patient sustained a non-displaced fracture 8.0 years post-operatively secondary to a bicycle accident that also resulted in other injuries.
Frequency: 2 affected / 131 at risk

Adverse event: Groin pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient presented with right groin pain 0.4 years post-operatively and was diagnosed with iliopsoas tendonitis.
Frequency: 1 affected / 131 at risk

Adverse event: Thigh pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient reported intermittent thigh pain at 8.6 year follow-up that began about 2 years previously.
Frequency: 1 affected / 131 at risk

Adverse event: Pubic ramus fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient sustained a pubic ramus fracture 5.4 years post-operatively that healed without intervention.
Frequency: 1 affected / 131 at risk

Adverse event: Abnornal sensation with range of motion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: At a routine follow-up appointment 1.1 years post-operatively, patient reported that hip seemed to "grab" in certain positions.
Frequency: 1 affected / 131 at risk

Adverse event: Fibrous stable stem
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Two patients were noted to have fibrous stable stems that were not bone ingrown on radiographs that were obtained 5.3 years post-operatively.
Frequency: 2 affected / 108 at risk