InjuryKXC
UNK
Received Mar 20, 1997 · Event occurred Feb 20, 1997
Report 78532 · MDR key 78532
Product problems
- Metal Shedding Debris
Patient
67 YR
- Surgical procedure
Narrative
Description of Event or Problem
PT HAD A RIGHT ANKLE REPLACEMENT APPROX 10 YEARS AGO. LAST YEAR SHE BEGAN DEVELOPING PAIN AND SWELLING. THE ANKLE IMPLANT WAS REMOVED DURING SURGERY ON 2/20/97. DURING SURGERY IT WAS DISCOVERED THAT THE TALAR COMPONENT ALONG WITH THE POLYETHYLENE COMPONENT WERE LOOSE. THE MEDIAL PART OF THE TALUS WAS TOTALLY DISINTEGRATED AND A LARGE AMOUNT OF METAL DEBRIS AND POLYETHYLENE WEAR WAS FOUND.