JOURNEY PF IMPLANT MED LT
Received Aug 25, 2015 · Event occurred Dec 7, 2011
Report 1020279-2015-00601 · MDR key 5029405
Device
Generic name
Patello-femoral Replacement
Manufacturer
Smith & Nephew, Inc.Catalog number
71461014
Lot number
09EM14423
Product problems
- Malposition of Device
- Device Operates Differently Than Expected
Patient
60 YR
- No Code Available
Narrative
Additional Manufacturer Narrative
CUSTOMER INDICATED THAT THERE IS NO PRODUCT/DEVICE TO BE RETURNED FOR INVESTIGATION ANALYSIS.
Description of Event or Problem
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO UNSATISFACTORY PATELLA TRACKING. THE REVISION PROCEDURE WAS A TIBIAL TUBERCLE SHIFT.
Additional Manufacturer Narrative
(B)(4). NO CLINICAL SUPPORTING DOCUMENTS HAVE BEEN PROVIDED TO CONDUCT A THROUGH ANALYSIS OF THE REPORTED DEVICE FAILURE. NO PRODUCT WAS RETURNED, HENCE VISUAL OR DIMENSIONAL INSPECTION COULD NOT BE COMPLETED. IN THE ABSENCE OF THE ACTUAL DEVICES, THE PRODUCTION RECORDS WERE REVIEWED FOR THE DEVICES REPORTEDLY INVOLVED IN THIS INCIDENT. DEVICE HISTORY RECORD REVIEW CONFIRMED THAT ALL RELEASED PARTS MET SPECIFICATIONS APPLICABLE AT THE TIME OF PRODUCTION. IF MORE INFORMATION IS RECEIVED, THIS INVESTIGATION WILL BE REOPENED.