BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF UNI C/LESS TIB TRAY LM C

    MDR report key: 5718601 · Received June 10, 2016

    Report

    Report Number
    3002806535-2016-00350
    Event Type
    Injury
    Date Received
    June 10, 2016
    Report Date
    May 11, 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 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 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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: DATE OF EVENT - NI. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT CONSERVATIVE TREATMENT DUE TO TIBIA FRACTURE WHICH OCCURRED APPROXIMATELY TWENTY-ONE DAYS POST-IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371708 OXF UNI C/LESS TIB TRAY LM C PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 3605049

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R