BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERLC BMPC LAT 6.0X132 12/14

    MDR report key: 5847950 · Received August 4, 2016

    Report

    Report Number
    3002806535-2016-00658
    Event Type
    Malfunction
    Date Received
    August 4, 2016
    Report Date
    July 7, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS 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. THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET IN THE UNITED STATES; HOWEVER, WE ARE FILING THIS REPORT AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K101086. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    THE PICTURE OF THE IMPLANT ON THE PACKAGE LABEL DOES NOT SHOW THE CORRECT IMPLANT DESIGN. THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY IN A PROCEDURE AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499878 TAPERLC BMPC LAT 6.0X132 12/14 PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 1583748

    Patients

    Seq Age Sex Outcome Treatment
    1