BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCEED ABT M2A-36 MOD HEAD -3MM T1

    MDR report key: 5693014 · Received June 1, 2016

    Report

    Report Number
    3002806535-2016-00308
    Event Type
    Injury
    Date Received
    June 1, 2016
    Date of Event
    March 21, 2013
    Report Date
    May 3, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    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. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(6) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(6) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K042037. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A TOTAL HIP ARTHROPLASTY. APPROXIMATELY 12 MONTHS LATER, PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT DUE TO INFECTION. A SECOND IRRIGATION AND DEBRIDEMENT WAS PERFORMED 10 DAYS AFTER THE FIRST AND THE FEMORAL HEAD WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346621 EXCEED ABT M2A-36 MOD HEAD -3MM T1 PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 1524522

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R