BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LPS ARTICULAR SURFACE SIZE CD 10 MM HEIGHT

    MDR report key: 25174402 · Received May 14, 2026

    Report

    Report Number
    0001822565-2026-01577
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 13, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00889024211766
    PMA / PMN Number
    K173057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 00-5980-037-01, TIBIAL COMPONENT, LOT: 67129781 G2: FOREIGN - EVENT OCCURRED IN CHINA. 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 DURING AN INITIAL TKA THE TIBIAL LINER COULD NOT BE ASSEMBLED TO THE TIBIAL TRAY. THE SURGICAL TECHNIQUE WAS UTILIZED; THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566045 LPS ARTICULAR SURFACE SIZE CD 10 MM HEIGHT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 66723982 00889024211766

    Patients

    Seq Age Sex Outcome Treatment
    1