FDA Adverse Event
Malfunction
Summary report: N
NEXGEN 10MM DISTAL FEM AUGMENT SZ B
MDR report key: 24390685
·
Received February 19, 2026
Report
- Report Number
- 0001822565-2026-00557
- Event Type
- Malfunction
- Date Received
- February 19, 2026
- Date of Event
- February 10, 2026
- Report Date
- May 14, 2026
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- JWH
- UDI-DI
- 00889024223899
- PMA / PMN Number
- K152494
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
(B)(4). G2: (B)(6). THE 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.
Description of Event or Problem · 0
IT WAS REPORTED THAT AN IMPLANT WAS RECEIVED AT RECEPTION WITH AN INCORRECT PHOTO ON THE PRODUCT LABEL. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 33337 | NEXGEN 10MM DISTAL FEM AUGMENT SZ B | PROSTHESIS, KNEE | JWH | ZIMMER BIOMET, INC. | 64011761 | 00889024223899 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |