BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50 TPR INSRT STD

    MDR report key: 3940925 · Received July 17, 2014

    Report

    Report Number
    0001825034-2014-06202
    Event Type
    Injury
    Date Received
    July 17, 2014
    Report Date
    June 18, 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. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. 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 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." 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 1825034-2014-06199/06202).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A HIP ARTHROPLASTY ON (B)(6), 2009. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, LACK OF MOBILITY, DAMAGE TO BONE/TISSUE, METALLOSIS, METAL TOXICITY, BONE EROSION, SYNOVIAL FLUID AND PSEUDOTUMOURS. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNKNOWN DATE. A REVIEW OF POST-OPERATIVE MEDICAL RECORDS CONFIRM PATIENT UNDERWENT A REVISION PROCEDURE DUE TO INFECTION WHERE CEMENT SPACER MOLDS WERE IMPLANTED. SUBSEQUENTLY, PATIENT UNDERWENT A REIMPLANTATION PROCEDURE ON AN UNKNOWN DATE WHERE COMPETITOR COMPONENTS WERE IMPLANTED. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE SURGERY DATE; HOWEVER, A REVISION INVOICE COULD NOT BE LOCATED TO CONFIRM THE REVISION PROCEDURE AND WHICH COMPONENTS WERE REMOVED AND REPLACED. 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
    420611 M2A-MAGNUM 42-50 TPR INSRT STD PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 297960

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R