BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM 12/14 TPR FEM HEAD -4 NK

    MDR report key: 5755610 · Received June 28, 2016

    Report

    Report Number
    3002806535-2016-00388
    Event Type
    Injury
    Date Received
    June 28, 2016
    Date of Event
    May 16, 2016
    Report Date
    May 30, 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
    BE
    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 THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS PRODUCT IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K042037.

    Description of Event or Problem · 1

    A PATIENT ENROLLED IN A CLINICAL STUDY REPORTED EXPERIENCING PAIN AND LOSS OF RANGE OF MOTION APPROXIMATELY 4 MONTHS POST-IMPLANTATION. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408651 36MM 12/14 TPR FEM HEAD -4 NK PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 3337965

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R