BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM TPR ADPR TI DIA42-50/+3MM(T1)

    MDR report key: 3905211 · Received July 1, 2014

    Report

    Report Number
    3002806535-2014-00165
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    June 2, 2014
    Report Date
    October 7, 2014
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT WAS RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. PRODUCT HAS BEEN REQUESTED, BUT NOT RETURNED YET. UPON RECEIPT OF ITEMS AND COMPLETION OF EVALUATION, AN MDR FOLLOW-UP WILL BE SUBMITTED TO THE FDA. THIS IS 2 OF 2 MDR REPORTS FOR THE SAME EVENT (ALSO SEE WARSAW ORTHOPEDICS MEDWATCH: 0001825034-2014-05810).

    Additional Manufacturer Narrative · 1

    THE EXPLANTED ITEMS WERE RETURNED FOR EVALUATION. ALTHOUGH THE REASON FOR REVISION WAS NOT STATED IT WAS OBSERVED THAT THE TAPER WAS FUSED AND COULD NOT BE SEPARATED. EXAMINATION OF THE RADIOGRAPHS AND BEARING SURFACES SUGGEST SUB OPTIMAL POSITIONING OF THE ACETABULAR COMPONENT, POSSIBLE JOINT LAXITY AND POSSIBLE ADVERSE WEAR CONDITIONS OF THE HEAD. THESE FACTORS MAY HAVE CONTRIBUTED TO ELEVATED STRESSES IN THE TAPER INTERFACE THAT COULD HAVE RESULTED IN A FRETTING/GALLING PROCESS LEADING ULTIMATELY TO THE FUSING OF THE COMPONENTS. NO FURTHER CONCLUSIONS CAN BE MADE WITHOUT FURTHER INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO UNKNOWN REASONS. DURING THE PROCEDURE, THE TAPER ADAPTER ALLEGEDLY WOULD NOT DISENGAGE FROM THE FEMORAL STEM. AN EXTENDED OSTEOTOMY TROCHANTER PROCEDURE WAS PERFORMED TO REMOVE THE TAPER ADAPTER AND FEMORAL STEM. A DELAY OF OVER 30 MINUTES OCCURRED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382509 M2A MAGNUM TPR ADPR TI DIA42-50/+3MM(T1) PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 1439385

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R