NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT
Report
- Report Number
- 0002648920-2025-00366
- Event Type
- Malfunction
- Date Received
- December 23, 2025
- Report Date
- April 14, 2026
- Manufacturer
- ZIMMER MANUFACTURING B.V.
- Product Code
- JWH
- PMA / PMN Number
- K173057
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). D10: 00596401552, FEMORAL COMPONENT OPTION SIZE E RIGHT COMPATIBLE WITH LPS-FLEX PROLONG, 61935971. 00596404012, ARTICULAR SURFACE SIZE EF 12 MM HEIGHT ''USE WITH PLATE 5, 61906121. 00597206535, ALL POLY PETELLA STANDARD CEMENTED SIZE 35 MM DIAMETER 9.0 MM THICKNESS, 61915691. 402283, COBALT G-HV BONE CEMENT 40G, 941920. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; D4; G1; G3; G6; H1; H2; H3; H4; H6. THE EVENT CANNOT BE CONFIRMED. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS AND RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A DEFINITIVE ROOT CAUSE CANNOT 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; B7; D2; G1; G3; G6; H1; H2 THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT KNEE SURGERY. SUBSEQUENTLY, THE PATIENT REPORTED TIBIAL LOOSENING; HOWEVER, IS NOT PLANNING TO BE REVISED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
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 |
|---|---|---|---|---|---|---|---|
| 2381332 | NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT | PROSTHESIS, KNEE | JWH | ZIMMER MANUFACTURING B.V. | 61844253 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | SEE H11. |