NEXGEN ALL POLY PATELLA
Received Jul 20, 2011 · Event occurred Mar 1, 2011
Report 1822565-2011-01664 · MDR key 2172624
Device
Product problems
- Explanted
- Fracture
- Loose
Patient
69 YR
- Surgical procedure, repeated
Narrative
Description of Event or Problem
IT IS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY FOR A CRACKED AND LOOSE PATELLA.
Additional Manufacturer Narrative
EVALUATION SUMMARY: X-RAYS WERE NOT PROVIDED. SURGICAL NOTES WERE PROVIDED AND SURGICAL TECHNIQUE REPORTED WAS REVIEWED TO BE CORRECT. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL ARE UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.