BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF TWIN-PEG CMNTD FEM SM PMA

    MDR report key: 3716593 · Received April 1, 2014

    Report

    Report Number
    0001825034-2014-02293
    Event Type
    Injury
    Date Received
    April 1, 2014
    Date of Event
    June 10, 2013
    Report Date
    March 3, 2014
    Manufacturer
    BIOMET U.K. LTD
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-02292 / 02293).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT RIGHT PARTIAL KNEE ARTHROPLASTY ON (B)(6), 2012. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2013 DUE TO PROGRESSION OF ARTHRITIS AND IMPINGEMENT BETWEEN THE FEMORAL AND TIBIAL COMPONENTS. BOTH COMPONENTS WERE REMOVED AND REPLACED WITH A TOTAL KNEE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193186 OXF TWIN-PEG CMNTD FEM SM PMA PROSTHESIS, KNEE NRA BIOMET U.K. LTD N/A 2674843

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R