BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR LATERALIZED TAPERLOC FEMORAL

    MDR report key: 7526286 · Received May 18, 2018

    Report

    Report Number
    0001825034-2018-03422
    Event Type
    Injury
    Date Received
    May 18, 2018
    Date of Event
    September 27, 2017
    Report Date
    May 17, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM #: 157444, ITEM NAME: M2A MAGNUM HEAD, LOT #: 309130, ITEM #: 139256, ITEM NAME: M2A TAPER ADAPTOR, LOT #: 520360, US157850 M2A-MAGNUM PF CUP 50ODX44ID LOT# 022410. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 02430 0001825034 - 2018 - 02421. REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED REVISION OP NOTES WHICH IDENTIFIED THAT THE PATIENT WAS REVISED DUE TO ADVERSE METAL REACTION AND CUP LOOSENING. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT WAS REVISED APPROXIMATELY EIGHT YEARS POST-IMPLANTATION DUE TO ADVERSE METAL REACTION AND ASEPTIC ACETABULAR CUP LOOSENING. DURING THE REVISION, SIGNIFICANT METALLOSIS, NECROTIC METAL-STAINED BONE AND TISSUE, LARGE CAVITARY DEFECTS, INCOMPLETE FRACTURE OF THE TROCHANTER, AND MODERATE ACETABULAR BONE LOSS WERE NOTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368576 MODULAR LATERALIZED TAPERLOC FEMORAL PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 309130

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R