JOURNEY PF IMPLANT MED LT
Received Aug 25, 2015 · Event occurred Aug 12, 2015
Report 1020279-2015-00603 · MDR key 5029422
Device
Generic name
Patello-femoral Replacement
Manufacturer
Smith & Nephew, Inc.Catalog number
71461014
Lot number
09EM14423
Product problems
- Insufficient Device Problem Information
Patient
63 YR
- Skin Tears
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 AFTER THE SKIN BROKE DOWN OVER THE IMPLANT. THE IMPLANT WAS REMOVED DURING THE REVISION.
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.