BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF UNI CMNTLS TIB SZ A RM

    MDR report key: 5718370 · Received June 10, 2016

    Report

    Report Number
    3002806535-2016-00353
    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. 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. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT UNKNOWN CONSERVATIVE TREATMENT DUE TO A TIBIA FRACTURE WHICH OCCURRED APPROXIMATELY EIGHT DAYS POST-IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371684 OXF UNI CMNTLS TIB SZ A RM PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R