BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP

    MDR report key: 6622377 · Received June 8, 2017

    Report

    Report Number
    0001825034-2017-03546
    Event Type
    Injury
    Date Received
    June 8, 2017
    Date of Event
    September 22, 2015
    Report Date
    December 2, 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)(6). CONCOMITANT PRODUCT(S): - M2A 38MM MOD HD -3MM NK/ PN 11-173661/ LN 747080, TAPERLOC MICROP FMRL 6.0MM/ PN 14-103201/ LN 374600. IT IS UNKNOWN IF THE DEVICE IS RETURNING FOR ANALYSIS; HOWEVER, ONCE THE INVESTGIATION IS COMPLETE ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT: 0001825034-2017-03547.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS ABLE TO BE CONFIRMED VIA OPERATIVE REPORT RECEIVED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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 · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY SEVEN YEARS POST-IMPLANTATION DUE TO UNSPECIFIED METAL ON METAL COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405034 M2A-MAGNUM PF CUP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 703880

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R