VANGUARD PFR FEMORAL RIGHT SM
Received Jul 25, 2017 · Event occurred Jun 14, 2017
Report 0009610576-2017-00030 · MDR key 6739786
Device
Generic name
Prosthesis, Knee
Manufacturer
Biomet Spain, S.l.Catalog number
11-150906
Lot number
2014041302
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Not reported
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION DUE TO LOCATION OF DEVICE IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY PROCEDURE. SUBSEQUENTLY THEY UNDERWENT A REVISION PROCEDURE DUE TO PROGRESSION OF DISEASE. THE PATIENT WAS CONVERTED TO A TOTAL KNEE.
Additional Manufacturer Narrative
UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.