VANGUARD ROCC POR FEM S55 R
Report
- Report Number
- 3006946279-2025-00067
- Event Type
- Malfunction
- Date Received
- June 4, 2025
- Date of Event
- May 15, 2025
- Report Date
- January 22, 2026
- Manufacturer
- BIOMET FRANCE S.A.R.L.
- Product Code
- MBH
- UDI-DI
- 03599870105412
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). D-4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). G2 ¿ FOREIGN ¿ JAPAN. G-4: 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 AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D9, G3, G6, H1, H2, H3, H6, H11. THE FOLLOWING SECTIONS WAS CORRECTED: H6 - COMPONENT CODE. 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 FOR THE REPORTED ITEM. 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 IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR 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.
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.
IT WAS REPORTED THAT IT WAS NOTICED DURING THE SURGERY THAT THE BLISTER CONTAINING IMPLANT IS FRACTURED. AS IT WAS SUSPECTED THAT THE STERILITY OF THE IMPLANT COULD BE COMPROMISED, A SPARE IMPLANT WAS USED, AND THE OPERATION WAS SUCCESSFULLY COMPLETED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 529828 | VANGUARD ROCC POR FEM S55 R | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED | MBH | BIOMET FRANCE S.A.R.L. | 0001597342 | 03599870105412 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |