BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MODULAR HEAD STD NK

    MDR report key: 3222606 · Received July 12, 2013

    Report

    Report Number
    0001825034-2013-02644
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 5, 2013
    Report Date
    October 24, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION. NO EVIDENCE OF PRODUCT NON-CONFORMANCES WAS FOUND.

    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.

    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 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2013 ALLEGEDLY DUE TO ELEVATED METAL ION LEVELS. THE HEAD AND TAPER ADAPTER WERE REMOVED. A POLYETHYLENE LINER AND CERAMIC HEAD WERE IMPLANTED. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATES METAL SYNOVITIS, METAL STAINED DEBRIS, AND SYNOVIAL TISSUE DURING THE (B)(6) 2013 REVISION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2013, ALLEGEDLY DUE TO ELEVATED METAL ION LEVELS. THE HEAD AND TAPER ADAPTER WERE REMOVED AND A POLYETHYLENE LINER AND CERAMIC HEAD WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322728 M2A 38MM MODULAR HEAD STD NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 125380

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R