VANGUARD ROCC POR FEM S57.5 L
Report
- Report Number
- 3006946279-2025-00055
- Event Type
- Malfunction
- Date Received
- May 13, 2025
- Date of Event
- April 24, 2025
- Report Date
- January 21, 2026
- Manufacturer
- BIOMET FRANCE S.A.R.L.
- Product Code
- MBH
- UDI-DI
- 03599870105337
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). D4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(6). G2 ¿ FOREIGN ¿ JAPAN. G4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K122745. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H11 UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT AND MEDWATCH REPORT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER 3002806535. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D9, G3, G6, H2, H3, H6, H11. VISUAL INSPECTION OF THE PICTURES PROVIDED SHOWS A CRACK ON ONE SIDE OF THE BLISTER THAT CONFIRMS THE EVENT. PERFORMED A VISUAL INSPECTION OF PACKAGING AND LABELING. OUTER PACKAGING (PRODUCT CARTON/BOX) EXHIBITS NO DAMAGE. INSPECTED INNER PLASTIC TRAY/CAVITY, CONFIRMING COMPLAINT IS CRACKED. TRAY/CAVITY DAMAGE WAS NOT TRANSFERRED THROUGH THE CARTON/BOX A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. REPORTED EVENT DID OCCUR IN AN OPERATING ROOM OR AS PART OF A MEDICAL PROCEDURE, BUT REVIEW OF THE MEDICAL RECORDS HAS NOT BEEN PERFORMED, AS THE EVENT IS NOT RELATED TO THE MEDICAL PROCEDURE. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED THAT DURING SURGERY, THE SURGEON NOTICED THAT THE OUTER PLASTIC CASE OF THE IMPLANT WAS DAMAGED. THE SURGEON ONLY NOTICED THIS DAMAGE AFTER THEY HAD REMOVED THE IMPLANT FROM THE PACKAGING, THEREFORE COULD NOT BE SURE IF THE STERILITY WAS COMPROMISED. THE SURGERY WAS COMPLETED WITH ANOTHER IMPLANT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT AND MEDWATCHREPORT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BEVOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER 3002806535.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1180703 | VANGUARD ROCC POR FEM S57.5 L | KNEE PROSTHESIS | MBH | BIOMET FRANCE S.A.R.L. | 0001700628 | 03599870105337 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |