BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF UNI C/LESS TIB TRAY RM AA

    MDR report key: 5659414 · Received May 17, 2016

    Report

    Report Number
    3002806535-2016-00247
    Event Type
    Injury
    Date Received
    May 17, 2016
    Report Date
    June 1, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY ADDITIONAL PRODUCT INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. 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. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER PMA NUMBER P010014.

    Description of Event or Problem · 1

    PATIENT UNDERWENT UNKNOWN CONSERVATIVE TREATMENT DUE TO TIBIAL PLATEAU FRACTURE WHICH OCCURRED APPROXIMATELY THREE WEEKS POST-IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314642 OXF UNI C/LESS TIB TRAY RM AA PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 3594656

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention