BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 54ODX48ID

    MDR report key: 8063545 · Received November 13, 2018

    Report

    Report Number
    0001825034-2018-10577
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    November 1, 2016
    Report Date
    February 25, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES STATING THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO ELEVATED METAL ION LEVELS, METALLOSIS AND PSEUDOTUMOR. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 · 0

    IT WAS REPORTED PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 9 YEARS POST IMPLANTATION DUE TO METALLOSIS, ELEVATED METAL ION LEVELS, AND PSEUDOTUMOR. DURING THE SURGERY, COBALT IN THE BLOOD WAS AT 80 OF UNKNOWN UNITS, THE CUP AND HEAD COMPONENTS WERE REMOVED AND REPLACED AND THE STEM WAS FOUND TO BE WELL FIXED THEREFORE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 139252 ¿ M2A MAGNUM TAPER INSERT ¿ 955280, 157448 ¿ M2A MAGNUM HEAD ¿ 955490, 11-103204 ¿ TAPERLOC FEMORAL STEM ¿ 388770. CUSTOMER HAS INDICATED THAT PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-10578, 0001825034-2018-10579, 0001825034-2018-10580.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 9 YEARS POST IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903464 M2A-MAGNUM PF CUP 54ODX48ID PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 954240

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R