BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 48MM

    MDR report key: 2792125 · Received October 16, 2012

    Report

    Report Number
    0001825034-2012-01926
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 22, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THIS REPORT IS NUMBER 1 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2012-01926-1, 01926, 2408 / 2411).

    Additional Manufacturer Narrative · 1

    EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE IS (OR MAY BE) NEEDED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY. 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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION PROVIDED IN OPERATIVE NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS THE LEFT HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2006 AND THE RIGHT HIP ARTHROPLASTY PROCEDURE OCCURED ON (B)(6) 2010. A SUBSEQUENT LEFT HIP REVISION PROCEDURE WAS PERFORMED (B)(6) 2012 ALLEGEDLY DUE TO INFECTION. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT M2A HIP ARTHROPLASTY ON (B)(6) 2010. LEGAL COUNSEL FOR PATIENT REPORTS ALLEGATIONS OF PERSONAL INJURIES. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. 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
    1 M2A-MAGNUM MOD HD SZ 48MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 945040

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R