BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLISHED IBEAM TIB TRAY 71MM

    MDR report key: 5781696 · Received July 11, 2016

    Report

    Report Number
    0009610576-2016-00007
    Event Type
    Injury
    Date Received
    July 11, 2016
    Date of Event
    June 9, 2016
    Report Date
    June 10, 2016
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 CLEARED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER ZIMMER BIOMET IN (B)(6) MANUFACTURES A SIMILAR DEVICE UNDER 510K NUMBER K915132. ADDITIONAL EVENTS ARE REPORTED FOR THIS PATIENT ON MDR NUMBERS 1825034-2016-02527 / 02528.

    Description of Event or Problem · 1

    PATIENT WAS REVISED APPROXIMATELY 5 YEARS POST-IMPLANTATION DUE TO A METAL ALLERGY. DURING THE PROCEDURE, ALL COMPONENTS WERE REPLACED WITH CEMENT SPACER MOLDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436683 POLISHED IBEAM TIB TRAY 71MM PROSTHESIS, KNEE JWH BIOMET SPAIN, S.L. N/A 2010030343

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R