BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNICOMPARTMENTAL PHASE 3 LEFT MEDIAL TIBIAL TRAY STD SIZE D

    MDR report key: 2073161 · Received April 29, 2011

    Report

    Report Number
    1825034-2011-00322
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    March 25, 2008
    Report Date
    March 31, 2011
    Manufacturer
    BIOMET UK LTD
    Product Code
    NRA
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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: "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY." DATE IMPLANTED: UNKNOWN. THIS REPORT FILED APRIL 29, 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PARTIAL KNEE ARTHROPLASTY AS PART OF A CLINICAL STUDY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT SUFFERED A GROUND LEVEL FALL DURING HOSPITAL STAY AND DISLOCATED HER MENISCAL BEARING. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2008 TO REMOVE AND REPLACE THE FEMORAL COMPONENT, TIBIAL TRAY AND TIBIAL BEARING. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXFORD UNICOMPARTMENTAL PHASE 3 LEFT MEDIAL TIBIAL TRAY STD SIZE D PROSTHESIS, KNEE NRA BIOMET UK LTD N/A 372151

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R