BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE GELNOSPHERE MINI BASEPLATE WITH TAPER ADAPTER

    MDR report key: 12365477 · Received August 25, 2021

    Report

    Report Number
    0001825034-2021-02495
    Event Type
    Injury
    Date Received
    August 25, 2021
    Date of Event
    January 24, 2020
    Report Date
    August 25, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304532465
    PMA / PMN Number
    K120121
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: CATALOG #: 110031399, MINI HUMERAL TRAY STANDARD THICKNESS, LOT # 64396704; CATALOG #: 110031418, BEARING STANDARD 36 MM DIAMETER, LOT # 64343765; CATALOG #: 113625, COMPREHENSIVE MINI PRIMARY STEM, LOT # 434380; CATALOG #: 115316, COMPREHENSIVE REVERSE GLENOSPHERE 36MM, LOT # 829820. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS DISCARDED. THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW, HOWEVER, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS PATIENT; PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT: 0001825034-2021-00954.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER ARTHROPLASTY REVISION APPROXIMATELY SIX (6) WEEKS POST-OPERATIVELY TO ADDRESS DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261890 COMPREHENSIVE REVERSE GELNOSPHERE MINI BASEPLATE WITH TAPER ADAPTER PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 966260 00880304532465

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R