BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPR RVS GLENO 2-PRNG INS/IMP

    MDR report key: 15005625 · Received July 13, 2022

    Report

    Report Number
    0001825034-2022-01633
    Event Type
    Malfunction
    Date Received
    July 13, 2022
    Report Date
    September 20, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00887868470011
    PMA / PMN Number
    K193373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSTRUMENT FRACTURED DURING A SURGICAL PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM OR FOREIGN OBJECT RETAINED BY THE PATIENT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408045 COMPR RVS GLENO 2-PRNG INS/IMP SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES KWS ZIMMER BIOMET, INC. 110028879 484010 00887868470011

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown