BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD SZ 44MM

    MDR report key: 2618325 · Received June 15, 2012

    Report

    Report Number
    0001825034-2012-00839
    Event Type
    Injury
    Date Received
    June 15, 2012
    Date of Event
    May 11, 2012
    Report Date
    May 17, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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: "MATERIAL SENSITIVITY REACTIONS." "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY MAY ALSO CONTRIBUTE TO THESE CONDITIONS." 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 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00838 / 00840).

    Additional Manufacturer Narrative · 1

    REVIEW OF EXPLANTED DEVICE FOUND FINER SCRATCHES AND DEEP SCRATCHES IN PARALLEL BANDS. THESE DEEPER SCRATCHES ARE POSSIBLE INDICATIONS OF EDGE CONTACT WITH THE RIM OF THE ACETABULAR CUP. THERE WAS NO EVIDENCE OF CHANGES IN SURFACE CONTOUR AT THE EDGES OF THE CONTACT AREA, FROM WHICH IT IS INFERRED THAT WEAR RATES WERE NOT EXCESSIVE. DEVICE MET SPECIFICATIONS FOR ALL MEASURABLE DIMENSIONS. THIS FOLLOW-UP REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00838-1 / 00840-1).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY PROCEDURE ON AN (B)(6) 2009. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO DISLOCATION AND SUSPECTED PSEUDOTUMOR THE ACETABULAR CUP, MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A-MAGNUM MODULAR HEAD SZ 44MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 207770

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R