BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCEED ABT M2A-36 MOD HEAD

    MDR report key: 5754696 · Received June 28, 2016

    Report

    Report Number
    3002806535-2016-00385
    Event Type
    Injury
    Date Received
    June 28, 2016
    Date of Event
    March 20, 2016
    Report Date
    June 15, 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
    DA
    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. THIS DEVICE IS NOT 510K CLEARED IN THE UNITED STATES; HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE UNDER 510K NUMBER K042037. MANUFACTURE DATE - DURING NOVEMBER 2013. THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 3002806535-2016-00025, 00385, 00386). REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT MANUAL MANIPULATION APPROXIMATELY 14 MONTHS POST-IMPLANTATION DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409432 EXCEED ABT M2A-36 MOD HEAD PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 321889

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R