BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER TIBIAL TRIAL INSERT PLATE

    MDR report key: 12883152 · Received November 26, 2021

    Report

    Report Number
    MW5105621
    Event Type
    Malfunction
    Date Received
    November 26, 2021
    Date of Event
    November 10, 2021
    Report Date
    November 23, 2021
    Manufacturer
    ZIMMER BIOMET / ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TIBIAL TRIAL PLATE BROKE IN HALF DURING TOTAL KNEE PROCEDURE. ALL PORTIONS RETRIEVED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1777223 ZIMMER TIBIAL TRIAL INSERT PLATE PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH ZIMMER BIOMET / ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female