BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A TAPER 37/28MM LINER

    MDR report key: 3191278 · Received June 26, 2013

    Report

    Report Number
    0001825034-2013-02281
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    May 30, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK993438
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 5 OF 7 MDRS FILED FOR THE SAME PERSON(REFERENCE 1825034-2012-02197-1, 2199-1, 2022-1 AND 2013-02280/02283). THE PREVIOUS REVISION PROCEDURE NOVEMBER 19, 2002 WAS REPORTED ON MEDWATCH NUMBER 1825034-2012-02198.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN OPERATIVE NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS A RIGHT HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2000 AND A LEFT HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2001. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2002, ON THE LEFT HIP DUE TO DISLOCATION. THE MODULAR HEAD WAS REMOVED AND REPLACED. FURTHER, PATIENT WAS AGAIN REVISED ON (B)(6) 2003, DUE TO AN UNKNOWN REASON. A STEM WAS REMOVED AND REPLACED WITH ANOTHER BIOMET STEM BUT NO INFORMATION IN WHICH HIP WAS REVISED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2003, WAS ON THE LEFT HIP WAS DUE TO BONE FRACTURE AND STEM INSTABILITY. THE OPERATIVE NOTES CONFIRM THAT THE FEMORAL STEM WAS REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN PATIENT'S BLOOD TESTS INDICATES ELEVATED COCR LEVELS. 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
    291497 M2A TAPER 37/28MM LINER PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 674420

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R