UNK NEXGEN KNEE COMPONENT
Received Aug 9, 2012
Report 1822565-2012-01700 · MDR key 2692978
Device
Generic name
Knee Prosthesis
Manufacturer
Zimmer, Inc.Product problems
- Insufficient Device Problem Information
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PT IS ALLEGING HARM CAUSED BY THE DEVICE; HOWEVER, THE NATURE OF THE HARM IS UNK AT THIS TIME.
Additional Manufacturer Narrative
EVAL SUMMARY: SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. 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 AVAILABLE INFORMATION, 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.