|
Model Number N/A |
Device Problems
Metal Shedding Debris (1804); Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)
|
Patient Problems
Pain (1994); Tissue Damage (2104); Toxicity (2333); Osteolysis (2377); Reaction (2414); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)
|
Event Type
Injury
|
Event Description
|
Legal counsel for patient reported patient underwent a right total hip arthroplasty on (b)(6) 2012.Subsequently, patient's legal counsel reports patient allegations of pain, loss of range of motion, bone/tissue damage, elevated metal ion levels and metallosis.There has been no reported revision procedure to date.This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.
|
|
Manufacturer Narrative
|
Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, "material sensitivity reactions." number 6 states, "inadequate range of motion due to improper selection or positioning of components." number 14 states, "postoperative bone fracture and pain." this report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.
|
|
Search Alerts/Recalls
|
|
|