ALPHA INSERT ME NEUTRAL HH/28
Received Nov 26, 2012 · Event occurred Oct 23, 2012
Report 9613350-2012-01095 · MDR key 2850058
Device
Product problems
- Device Slipped
Patient
68 YR
- No Code Available
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A REVISION TOOK PLACE BECAUSE THE METAL PART INSIDE THE ALPHA INSERT LOOSENED FROM THE OUTER PE PART OF THIS INSERT.
Additional Manufacturer Narrative
THE MANUFACTURER HAS NOT YET RECEIVED EXPLANTED DEVICES REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THE CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. HOWEVER THERE IS NO INDICATION FOR A PRODUCT FAILURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).