BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM TAPER ADAPTOR

    MDR report key: 1183524 · Received October 3, 2008

    Report

    Report Number
    1825034-2008-00251
    Event Type
    Injury
    Date Received
    October 3, 2008
    Date of Event
    August 15, 2008
    Report Date
    September 8, 2008
    Manufacturer
    BIOMET INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT. A FAX WAS SENT TO INFORM THE USER FACILITY OF THE EVENT. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO FDA. THE FOLLOWING USER FACILITY INFORMATION IS AVAILABLE: EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE WAS INCONCLUSIVE. THIS REPORT FILED DECEMBER 10, 2008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION PROCEDURE IN 2008. THE SURGEON INTENDED TO LEAVE THE FEMORAL STEM FIXED IN PLACE; HOWEVER, THE TAPER JUNCTION BETWEEN THE STEM AND THE FEMORAL HEAD WOULD NOT SEPARATE FROM THE STEM, REQUIRING IT TO BE REMOVED. A 1 1/2 HOUR DELAY IN THE PROCEDURE WAS EXPERIENCED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION PROCEDURE 2008. THE SURGEON INTENDED TO LEAVE THE FEMORAL STEM FIXED IN PLACE; HOWEVER, THE TAPER JUNCTION BETWEEN THE STEM AND THE FEMORAL HEAD WOULD NOT SEPARATE FROM THE STEM, REQUIRING IT TO BE REMOVED A 1 1/2 HOUR DELAY IN THE PROCEDURE WAS EXPERIENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MAGNUM TAPER ADAPTOR PROSTHESIS, HIP COMPONENT KWA BIOMET INC. N/A 970680

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R