BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGC DA2000 KN TIB BRG 71/75X14

    MDR report key: 5917921 · Received August 31, 2016

    Report

    Report Number
    3002806535-2016-00697
    Event Type
    Injury
    Date Received
    August 31, 2016
    Report Date
    August 1, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    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 OR DEVIATION. 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 K921182. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS EXPERIENCING RIGHT POLYETHYLENE WEAR APPROXIMATELY THIRTEEN YEARS POST-IMPLANTATION. A REVISION PROCEDURE IS ALLEGEDLY PLANNED TO REMOVE THE POLYETHYLENE BEARING. HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568639 AGC DA2000 KN TIB BRG 71/75X14 PROSTHESIS, KNEE JWH BIOMET UK LTD. N/A 352418

    Patients

    Seq Age Sex Outcome Treatment
    1 Other