BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM SYSTEM

    MDR report key: 6533982 · Received May 1, 2017

    Report

    Report Number
    0001825034-2017-02388
    Event Type
    Injury
    Date Received
    May 1, 2017
    Date of Event
    January 26, 2017
    Report Date
    November 26, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED. THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 0001825034-2017-02386, 0001825034-2017-02387, 0001825034-2017-02389).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL, UPDATED AND CORRECTED INFORMATION. MEDICAL DEVICES: CER BIOLOXD OPTION HD 28MM P/N 650-1055 L/N 263690, CER OPTION TYPE 1 TPR SLEVE +3 P/N 650-1067 L/N 603970, ACT ARTIC E1 HIP BRG 28X50MM P/N EP-200156 L/ N 093280, TAPERLOC POR FMRL 17.5X155 P/N 103209 L/N 565620. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD 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 · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY 2 MONTHS POST IMPLANTATION DUE TO PAIN. OPERATIVE NOTES INDICATED POLY BEARING WEAR AND MALPOSITION OF THE CUP. MULTIPLE POLYETHYLENE SHAVINGS IN THE SOFT TISSUES; THESE WERE REMOVED METICULOUSLY. THE CUP AND POLY BEARING WERE EXPLANTED. THE CUP WAS EXPLANTED AS THE SURGEON FELT THE POSITION OF THE CUP COULD BE A CONTRIBUTING FACTOR TO THE PATIENT'S PAIN. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316890 M2A MAGNUM SYSTEM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 990940

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R