BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SULOX¿¢, HEAD, L, ø 32/+3.5, TAPER 12/14

    MDR report key: 20673254 · Received November 13, 2024

    Report

    Report Number
    0009613350-2024-00535
    Event Type
    Injury
    Date Received
    November 13, 2024
    Date of Event
    June 15, 2024
    Report Date
    January 22, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    UDI-DI
    00889024416994
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4): D10: ITEM # 0100013410, DURASUL®, ALPHA INSERT, JJ/32, LOT # 3191683; ITEM # 0100551109, FITMORE®, HIP STEM, UNCEMENTED, A/9, TAPER 12/14, LOT # 3152758; ITEM # 4246, ALLOFIT® ALLOCLASSIC®, SHELL WITH POLAR SCREW PLUG, UNCEMENTED, 54/JJ, LOT # 3196055. G2: REPORT SOURCE GERMANY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS EVENT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MDR NUMBER AS IS A DUPLICATE. THIS REPORT SHOULD BE VOIDED AND REPORTABILITY WILL BE CONTINUE UNDER 0009613350-2024-00297.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM LEGAL THAT A PATIENT UNDERWENT HIP REVISION APPROXIMATELY 1 MONTH POST IMPLANTATION DUE TO IMPLANT FRACTURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS EVENT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MDR NUMBER AS IT IS A DUPLICATE. THIS REPORT SHOULD BE VOIDED AND REPORTABILITY WILL BE CONTINUE UNDER 0009613350-2024-00297.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2421311 SULOX¿¢, HEAD, L, ø 32/+3.5, TAPER 12/14 PROSTHESIS, HIP LZO ZIMMER GMBH N/A 3185367 00889024416994

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention| H