BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MODULAR HEAD COMPONENT 28MM+6MM

    MDR report key: 15500924 · Received September 28, 2022

    Report

    Report Number
    3002806535-2022-00413
    Event Type
    Injury
    Date Received
    September 28, 2022
    Date of Event
    February 29, 2012
    Report Date
    September 27, 2022
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MEDICAL PRODUCTS EXCEED ABT E1 MULLER CUP 28X56; ITEM: EP-122856: LOT: 2241124. UNKNOWN MALLORY HEAD STEM 12X165MM. FOREIGN NETHERLANDS STUDY CLINICAL STUDY ORTHO.CR.GH005. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3002806535 -2022 -00412. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS

    Description of Event or Problem · 0

    IT WAS REPORTED IN A CLINICAL STUDY THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 1 MONTH POST IMPLANTATION DUE TO DISLOCATION WHERE THE HEAD WAS EXCHANGED AND IMPINGEMENT OF THE FRONT LEFT ACETABULUM DUE TO OSTEOPHYTES WAS REMOVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2257532 UNKNOWN MODULAR HEAD COMPONENT 28MM+6MM HIP PROSTHESIS LZO BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H