BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF PKS ANAT MEN BRG UHMWPE LT SML SZ 4

    MDR report key: 3890225 · Received June 24, 2014

    Report

    Report Number
    3002806535-2014-00155
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 30, 2014
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT WAS RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT KNEE SURGERY ON (B)(6) 2012. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO DISLOCATION. NO FURTHER INFORMATION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369200 OXF PKS ANAT MEN BRG UHMWPE LT SML SZ 4 PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 2580049

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R