NATURAL KNEE II PATELLA FEMORAL COMPONENT
Received Sep 28, 2012 · Event occurred Feb 22, 2012
Report 1822565-2012-02004 · MDR key 2774598
Device
Product problems
- Insufficient Device Problem Information
Patient
56 YR
- Unspecified Infection
Narrative
Description of Event or Problem
IT IS REPORTED THAT THE PT UNDERWENT IRRIGATION AND DEBRIDEMENT WITH DRAIN PLACEMENT DUE TO INFECTION.
Additional Manufacturer Narrative
EVAL SUMMARY: REVIEW OF SURGICAL REPORTS PROVIDED INDICATES SURGICAL TECHNIQUE WAS FOLLOWED. X-RAYS WERE RECEIVED, SHOWING THAT THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. THE ZIMMER STERILIZATION VENDOR PROCESSES ALL IMPLANTS TO MEET FDA REGULATIONS AND ISO STANDARDS AT A STERILITY ASSURANCE LEVEL (SAL) OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO ANY PT INFECTION. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. 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 ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.