PERSONA MC VE ASF R
Report
- Report Number
- 3007963827-2025-00012
- Event Type
- Injury
- Date Received
- January 6, 2025
- Date of Event
- December 10, 2024
- Report Date
- May 1, 2025
- Manufacturer
- ZIMMER ORTHOPAEDIC MFG. LTD.
- Product Code
- MBH
- UDI-DI
- 00889024468436
- PMA / PMN Number
- K150090
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). D10 - MEDICAL PRODUCT: PSN TIB STM 5 DEG SZ E R CATALOG # 42532007102 LOT # 64624454. ALL POLY PATELLA CEMENTED 35 MM DIAMETER CATALOG # 42540000035 LOT # 64775275 FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT SIZE 8 CATALOG # 42502606402 LOT # 64638054. PERSONA CEM FEM/CEM TIB/M CATALOG # 98-0002-400-22 LOT # UNK. H3: 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.
THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G4, G7, H1, H2, H3, H6, H9, H10. EXCESSIVE WEAR CONFIRMED ON ARTICULAR SURFACE. LOOSENING NOT CONFIRMED ON TIBIA. VISUAL EVALUATION OF THE RETURNED DEVICE SHOWS THE DOVETAIL FEATURE EXHIBITS DAMAGE THE ART SURFACE EXHIBITS SIGNS OF WEAR. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.
THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. UPDATED: B4, B5, D2, G1, G3, G6, H1, H2. CORRECTION: H11. H11: LOOSENING NOT CONFIRMED ON TIBIA IS N/A WHICH WAS REPORTED ON INITIAL REPORT.
IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE FOUR YEARS POST IMPLANTATION DUE TO UNKNOWN REASON. GROSS TIBIA FAILURE AND PITTING WAS NOTICED ON THE ARTICULAR SURFACE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.
IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE FOUR YEARS POST IMPLANTATION DUE TO LOOSE TIBIAL COMPONENT. GROSS TIBIA FAILURE AND PITTING WAS NOTICED ON THE ARTICULAR SURFACE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 360910 | PERSONA MC VE ASF R | PROSTHESIS KNEE | MBH | ZIMMER ORTHOPAEDIC MFG. LTD. | N/A | 64649805 | 00889024468436 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| H |