BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAL SIZER FOR SHOULDER

    MDR report key: 12985429 · Received December 10, 2021

    Report

    Report Number
    MW5105989
    Event Type
    Malfunction
    Date Received
    December 10, 2021
    Date of Event
    November 19, 2021
    Report Date
    December 8, 2021
    Manufacturer
    DON JOY ORTHOPEDIC / ENCORE MEDICAL, L. P.
    Product Code
    KWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PRODUCT PROBLEM: UPON REMOVAL OF THE SHOULDER DJO (MANUFACTURER) HUMERAL HEAD TRIAL, THE TRIAL BROKE. THE VENDOR WAS PRESENT DURING THE PROCEDURE AND WAS AWARE OF THE SIZER HEAD ISSUE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1871868 TRIAL SIZER FOR SHOULDER PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS DON JOY ORTHOPEDIC / ENCORE MEDICAL, L. P.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male