BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP

    MDR report key: 7359522 · Received March 21, 2018

    Report

    Report Number
    0001825034-2018-02085
    Event Type
    Injury
    Date Received
    March 21, 2018
    Date of Event
    February 23, 2018
    Report Date
    April 25, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO IMPLANTS REMAINING IN PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: BIOMET M2A-MAGNUM MOD HD SZ 52 MM ITEM #: 157452 LOT #: 022620, BIOMET M2A-MAGNUM 52-60 MM TPR INSRT-3 ITEM #: 139266 LOT #: 253770, BIOMET TAPERLOC MICRO LAT FMRL 11 MM ITEM #: 15-103205 LOT #: 826730. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-02072, 0001825034-2018-02078, 0001825034-2018-02079.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD 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 A PATIENT UNDERWENT AN ATTEMPTED HIP REVISION APPROXIMATELY 11 YEARS POST-IMPLANTATION DUE TO UNKNOWN REASONS. DURING THE PROCEDURE, AN INTRAOPERATIVE COMPLICATION OCCURRED, PREVENTING THE COMPLETION OF THE REVISION. FURTHER INFORMATION ABOUT A RESCHEDULED REVISION HAS NOT BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202329 M2A-MAGNUM PF CUP HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 172760

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R