BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF PKS DOMED LAT MEN BRG UHMW PE MED SZ4

    MDR report key: 5355228 · Received January 8, 2016

    Report

    Report Number
    3002806535-2016-00019
    Event Type
    Injury
    Date Received
    January 8, 2016
    Date of Event
    December 15, 2015
    Report Date
    December 17, 2015
    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
    AS
    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 OR DEVIATION. 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 WARSAW, INDIANA MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER P010014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2015 DUE TO INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14566 OXF PKS DOMED LAT MEN BRG UHMW PE MED SZ4 PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 1520551

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R