BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERLOC PC 15.0 MM 12/14

    MDR report key: 5847951 · Received August 4, 2016

    Report

    Report Number
    3002806535-2016-00659
    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. PMA 510(K): 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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: DATE OF EVENT - NI. INITIAL REPORTER - NAME NI. 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
    499800 TAPERLOC PC 15.0 MM 12/14 PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 2786670

    Patients

    Seq Age Sex Outcome Treatment
    1