BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 52MM

    MDR report key: 3902941 · Received June 30, 2014

    Report

    Report Number
    0001825034-2014-05851
    Event Type
    Injury
    Date Received
    June 30, 2014
    Report Date
    July 14, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 2 OF 4 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05850 / -05851 & -06572 / -06573).

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THESE TYPES OF EVENTS CAN OCCUR UNDER POSSIBLE ADVERSE EFFECTS: INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-05850 / 05851).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009 AND LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, IT IS ALLEGED THAT PATIENT¿S RIGHT HIP WAS REVISED ON (B)(6) 2013 DUE TO ALLEGATIONS OF PAIN. THERE HAS BEEN NO REPORTED LEFT HIP REVISION PROCEDURE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378994 M2A-MAGNUM MOD HD SZ 52MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 399810

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization