BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PKS TIB TRAY COCR 47X30MM RM

    MDR report key: 2832333 · Received November 14, 2012

    Report

    Report Number
    3002806535-2012-00338
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    September 7, 2012
    Report Date
    October 15, 2012
    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
    UK
    Reporter Occupation
    OTHER

    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.IMPLANT DATE - UNKNOWN.THIS IS 1 OF 3 REPORTS RELATED TO THE SAME EVENT. (SEE 3002806535-2012-00338/340).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY OXFORD SURGERY ON AN UNKNOWN DATE. REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2012 DUE TO PROGRESSION LATERAL OA, LOOSE TIBIAL COMPONENTS, POSTERIOR WEAR AND POLY IMPINGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXFORD PKS TIB TRAY COCR 47X30MM RM OXFORD TIBIAL TRAY NRA BIOMET UK LTD. N/A 502107

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R