BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR TAPERLOC FEMORAL

    MDR report key: 6946331 · Received October 12, 2017

    Report

    Report Number
    0001825034-2017-08607
    Event Type
    Injury
    Date Received
    October 12, 2017
    Date of Event
    September 29, 2014
    Report Date
    October 12, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET M2A MAGNUM TAPER ADAPTER CATALOG#: 139254 LOT#: 060720 M2A MAGNUM MODULAR HEAD, CATALOG#: 157442, LOT#: 617070 M2A MAGNUM PF CUP, CATALOG#: US157848, LOT#: 150960. THIS IS ONE OF MULTIPLE MDRS FILED FOR THIS EVENT: 1825034-2016-03736, 03737, AND 1825034-2017-08607. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. 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

    PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY FIVE YEARS POST-IMPLANTATION DUE TO PATIENT ALLEGATIONS OF ELEVATED LEVELS OF COCR, PAIN, DISCOMFORT, POPPING SENSATION, ANTALGIC GAIT, SORENESS, SIGNIFICANT AMOUNT OF METALLIC-STAINED TISSUE AND DEHISCENCE OF THE POSTERIOR HIP IMPLANT WITH NOTATIONS. IT WAS REPORTED IN OPERATIVE REPORT RECEIVED THAT PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY FIVE YEARS POST-IMPLANTATION DUE TO METALLOSIS WITH OSTEOLYSIS AND MALPOSITION. DURING THE PROCEDURE, AN OSTEOLYTIC LESION AND DEBRIS, BONE LOSS AND THE REMOVAL OF BRUSAL AND SYNOVIAL TISSUE WERE NOTED. ALL COMPONENTS WERE REMOVED AND REPLACED WITH LEGACY ZIMMER PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725661 MODULAR TAPERLOC FEMORAL PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 746740

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R