BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD SZ 52MM

    MDR report key: 5991824 · Received September 30, 2016

    Report

    Report Number
    0001825034-2016-03899
    Event Type
    Injury
    Date Received
    September 30, 2016
    Date of Event
    August 3, 2015
    Report Date
    October 5, 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
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-03805, 03851, 03854, 03890, 03899).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). CONCOMITANT MEDICAL PRODUCTS - M2A-MAGNUM PF CUP 58ODX52ID/ PN US157858/ LN 132560, TAPERLOC POR RED/LAT 15X150/ PN 13-103208/ LN 363050, M2A MAGNUM TPR ADPR TI DIA52-6 0/0MMT1/ PN 139268/ LN 953510.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED EVENT COULD NOT BE CONFIRMED BASED ON LIMITED INFORMATION RECEIVED. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE, THE VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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 AN UNKNOWN SURGICAL PROCEDURE POST-IMPLANTATION. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A SURGERY TO REPAIR RIGHT ADDUCTOR MUSCLES. WHILE REPAIRING MUSCLES, METALLOSIS WAS FOUND. NOTHING WAS IMPLANTED OR EXPLANTED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641791 M2A-MAGNUM MODULAR HEAD SZ 52MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 134710

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R