BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER BIOMET TRIAL

    MDR report key: 16529568 · Received March 10, 2023

    Report

    Report Number
    MW5115673
    Event Type
    Malfunction
    Date Received
    March 10, 2023
    Date of Event
    March 3, 2023
    Report Date
    March 9, 2023
    Manufacturer
    ZIMMER/BIOMET, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CRACKED TRIAL FOUND IN A ZIMMER LOANER PAN DURING ASSEMBLY. VENDOR: ZIMMER/BIOMET. ITEM# 42-5274-010-10 (SIZE 10-12/G-H) VENDORS MUST DO A BETTER JOB WITH CHECKING THEIR INSTRUMENTATION FOR FUNCTIONALITY AND CLEANLINESS BEFORE BRINGING THEM INTO THE FACILITY. ZIMMER/BIOMET. ZIMMER REP LOCATION: MADISON WI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836684 ZIMMER BIOMET TRIAL PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH ZIMMER/BIOMET, INC. 42-5274-010-10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown