BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORMANCE MODULAR TIBIAL TRAY SML

    MDR report key: 6036204 · Received October 18, 2016

    Report

    Report Number
    0009610576-2016-00011
    Event Type
    Injury
    Date Received
    October 18, 2016
    Report Date
    September 19, 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
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4). DATE IMPLANTED - NI. THIS DEVICE IS NOT CLEARED FOR DISTRIBUTION IN THE US, BUT ZIMMER BIOMET IN THE US MARKETS/MANUFACTURES A SIMILAR DEVICE UNDER 510K NUMBER K915132. THIS REPORT IS NUMBER 3 OF 7 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0009610576-2016-00009/00014 & 3006946279-2016-00377).

    Description of Event or Problem · 1

    PATIENT HAS BEEN INDICATED FOR ALLERGY TESTING DUE TO PAIN AND POSSIBLE ALLERGIC REACTION POST-IMPLANTATION. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688503 PERFORMANCE MODULAR TIBIAL TRAY SML PROSTHESIS, KNEE JWH BIOMET SPAIN, S.L. N/A 2014090656

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention