VANGUARD SSK 360 FEMUR L 62.5
Received Jun 21, 2018
Report 0001825034-2018-04116 · MDR key 7626238
Device
Generic name
Prosthesis, Knee
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
185283
Lot number
3515129
Product problems
- Device Packaging Compromised
- Device Packaging Compromised
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
(B)(4). (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-04115 AND 0001825034-2018-04116. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
IT WAS REPORTED THAT DURING STOCK INVESTIGATION THE STERILE PACKAGING WAS FOUND TO BE CRACKED AND DEFORMED. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
THE REPORTED EVENT WAS CONFIRMED AS PRODUCT WAS RETURNED AND INSPECTION OF THE BOX SHOWS THAT THE INNER CAVITY HAS A COSMETIC DEFECT TO THE CAVITY. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE ROOT CAUSE FOR THE BLISTER DEFORMATIONS IS DUE TO THE VARIABLE THICKNESS AND NO HEAD-SPACE IN A SHELF CARTON. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.