NEXGEN ALL POLY PATELLA
Received Sep 29, 2011
Report 2648920-2011-00071 · MDR key 2275410
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Pain
Narrative
Description of Event or Problem
IT IS REPORTED THAT THE PT IS EXPERIENCING PAIN.
Additional Manufacturer Narrative
EVAL SUMMARY: NEITHER SURGICAL NOTES NOR X-RAYS WERE PROVIDED, THEREFORE, FIT AND ORIENTATION COULD NOT BE EVALUATED. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL OR TYPE OF ACTIVITY (LOW IMPACT VS HIGH IMPACT) ARE UNK. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. HOWEVER, THE COMPLAINT MAY BE REVISED UPON RETURN OF OPERATIVE REPORTS, X-RAYS, PRODUCT OR FURTHER INFO. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PATELLA WERE REVIEWED AND DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. PLEASE REFERENCE MDR 1822565-2011-00880 WHICH WAS PREVIOUSLY SUBMITTED. UPON FURTHER INVESTIGATION IT WAS DETERMINED THAT PRODUCT WAS MFR AT ZIMMER (B)(4).