BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50M TPR INSRT +3

    MDR report key: 3007469 · Received March 15, 2013

    Report

    Report Number
    0001825034-2013-00622
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    January 25, 2013
    Report Date
    February 20, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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 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. THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00620 / 00623).

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE EXPLANTED DEVICES FOUND EVIDENCE THAT THE HEAD APPEARED TO SHOW EVIDENCE OF SUBLUXATION OF THE JOINT AND SCRATCHING OF THE BEARING SURFACES. DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00622-1 / 00623-1).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2010 ALLEGEDLY DUE TO MULTIPLE DISLOCATIONS. THE HEAD, CUP AND LINER WERE REMOVED AND REPLACED WITH M2A HEAD, CUP AND TAPER ADAPTER. FURTHER, PATIENT WAS REVISED ON (B)(6) 2013 ALLEGEDLY DUE TO A PSEUDOTUMOR. THE HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED WITH BIOMET PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109652 M2A-MAGNUM 42-50M TPR INSRT +3 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 183160

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R