BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SIZE 46MM

    MDR report key: 6631916 · Received June 9, 2017

    Report

    Report Number
    0001825034-2017-03770
    Event Type
    Injury
    Date Received
    June 9, 2017
    Date of Event
    February 17, 2015
    Report Date
    October 4, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: UNKNOWN TAPER ADAPTER. THE INVESTIGATION IS STILL IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-03771.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: ITEM # 103202; LOT # 826360 TAPERLOC POR FEMORAL 7.5X135, ITEM # 139256; LOT # 404870 M2A-MAGNUM 42-50 TAPER INSERT STD, ITEM # 157446; LOT # 235820 M2A-MAGNUM MOD HD SIZE 46 MM, ITEM # US157852; LOT # 230680 M2A-MAGNUM PF CUP 52ODX46ID. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OP NOTES. REVIEW OF THE REVISION OP NOTES REVEAL THE MORSE TAPER SHOWED SOME CORROSIVE CHANGES BELOW THE HEAD STEM JUNCTION. 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 THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY SEVEN YEARS POST INITIAL IMPLANTATION DUE TO PAIN. IT WAS NOTED THAT THERE WAS CLOUDY FLUID SURROUNDING THE JOINT WITH MODERATE PSEUDOCYST FORMATION. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411358 M2A-MAGNUM MOD HD SIZE 46MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 235820

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| O