BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF TWIN-PEG CMNTD FEMORAL XS PMA

    MDR report key: 3889970 · Received June 24, 2014

    Report

    Report Number
    0001825034-2014-05713
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    February 18, 2014
    Report Date
    March 3, 2016
    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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT INFORMATION. DEVICE REQUESTED BUT NOT RETURNED BY HOSPITAL.

    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: "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05713 / 05714).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO DISLOCATION. ALL COMPONENTS WERE REMOVED AND REPLACED WITH A TOTAL KNEE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368350 OXF TWIN-PEG CMNTD FEMORAL XS PMA PROSTHESIS, KNEE NRA BIOMET U.K. LTD N/A 813460

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R