BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GLENOSPHERE

    MDR report key: 20333764 · Received September 30, 2024

    Report

    Report Number
    0001822565-2024-03101
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    August 31, 2024
    Report Date
    January 15, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K181611
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - MEDICAL PRODUCT: CATALOG #: 110031418, STANDARD 36MM DIAMETER BEARING, LOT # 66638022, CATALOG #: 113628, COMP PRIMARY STEM 8MM MINI, LOT # 66255332, CATALOG #: 010000589, COMP RVRS 25MM BSPLT HA+ADPTR, LOT # 66535816. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE HAS BEEN REQUESTED BUT NOT RETURNED BY HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS COMPONENT WAS REPORTED UNDER THE INCORRECT MFR NUMBER. THE EVENT WILL BE REPORTED UNDER THE CORRECT MFR NUMBER (0001825034-2025-00151); THEREFORE, THIS REPORT SHOULD BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS PRESENTED IN THE SURGEON'S OFFICE WITH A DISLOCATED SHOULDER. DETAILS OF HOW THIS OCCURRED WERE UNCLEAR. THE HUMERAL STEM, TRAY, AND POLYETHYLENE INSERT WERE REVISED. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS COMPONENT WAS REPORTED UNDER THE INCORRECT MFR NUMBER. THE EVENT WILL BE REPORTED UNDER THE CORRECT MFR NUMBER (0001825034-2025-00151); THEREFORE, THIS REPORT SHOULD BE VOIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962705 UNKNOWN GLENOSPHERE EXTREMITY IMPLANT KWS ZIMMER BIOMET, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention| H