BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50MM TPR INSRT-3

    MDR report key: 4233779 · Received November 6, 2014

    Report

    Report Number
    0001825034-2014-08550
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 27, 2010
    Report Date
    October 28, 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
    NY, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06728 / 06730 & -08550).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. PATIENT'S LEGAL COUNSEL FURTHER REPORTS PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, BONE/TISSUE DAMAGE, ELEVATED METAL ION LEVELS AND METALLOSIS. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2011. THE MODULAR HEAD WAS REMOVED AND REPLACED. REVIEW OF INVOICE HISTORY CONFIRMED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND A REVISION PROCEDURE ON AN UNKNOWN SIDE ON (B)(6) 2010. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT OPERATIVE (OP) NOTES DATED (B)(6) 2010 REPORTS, PATIENT WAS REVISED ON THE LEFT HIP DUE TO MIGRATION OF THE ACETABULAR COMPONENT. REVISION OP REPORT NOTES THE PRESENCE OF METALLOSIS, POCKETS OF METAL DEBRIS-LINED SYNOVIUM, AND A FRACTURE OF THE GREATER TROCHANTER. IN ADDITION, OP REPORT NOTES THE HEAD WAS COLD WELDED. THE CUP, HEAD, AND TAPER INSERT WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN PATIENT OP NOTES DATED (B)(6) 2011, REPORTS THE RIGHT HIP WAS REVISED DUE TO PAIN AND POPPING. REVISION OP REPORT NOTES THE PRESENCE OF METALLOSIS AND CLOUDY FLUID. IN ADDITION, OP REPORT NOTES THE POPPING WAS A RESULT OF IMPINGEMENT OF TROCHANTER ON POSTERIOR RIM OF ACETABULAR COMPONENT, WHICH WAS ANTEVERTED BUT STABLE. THE HEAD WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715800 M2A-MAGNUM 42-50MM TPR INSRT-3 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 156860

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R