BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNEE UNK TIBIAL

    MDR report key: 24755278 · Received April 1, 2026

    Report

    Report Number
    0001822565-2026-01035
    Event Type
    Injury
    Date Received
    April 1, 2026
    Report Date
    April 1, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: #ITEM 42-5110-004-10, PSN ASF CR 10MM PLY L 3-9 CD, #LOT UNK. #ITEM 42-5026-056-01,PSN FEM CR CMT CCR STD SZ 4 L, #LOT UNK. THERAPY DATE: REMAINS IMPLANTED. G2: FOREIGN - EVENT OCCURRED IN UNITED KINGDOM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A LEFT TOTAL KNEE REPLACEMENT. SUBSEQUENTLY, THE PATIENT DEVELOPED INCREASING LEFT KNEE PAIN, AND IMAGING APPROXIMATELY 4 YEARS POST-IMPLANTATION INDICATED TIBIAL COMPONENT FAILURE WITH REVISION RECOMMENDED. THE PATIENT EXPERIENCED INCREASING KNEE PAIN AND HAD NOT BEEN LISTED FOR REVISION SURGERY AT THE TIME OF REPORT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812766 KNEE UNK TIBIAL PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other