BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNICOMPARTMENTAL KNEE PHASE 3 RIGHT MEDIAL TIBIAL TRAY STD SZ C

    MDR report key: 2001845 · Received February 25, 2011

    Report

    Report Number
    1825034-2011-00134
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    October 27, 2010
    Report Date
    January 31, 2011
    Manufacturer
    BIOMET UK LTD
    Product Code
    NRA
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "IMPLANT FRACTURE AND LOOSENING DUE TO CEMENT FAILURE HAS BEEN REPORTED." THE DEVICE IS IN A CLINICAL STUDY AND NOT AVAILABLE FOR EVALUATION. THIS REPORT FILED (B)(6), 2011.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM CLINICAL RESEARCH STATES THAT PATIENT UNDERWENT PARTIAL KNEE ARTHROPLASTY ON (B)(6) , 2008 AS PART OF A CLINICAL STUDY AND THAT A SUBSEQUENT REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2010. THE INFORMATION PROVIDED INDICATES THAT THE CEMENT HAD LOOSENED AND THE TIBIAL BEARING MOVED OUT OF PLACE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXFORD UNICOMPARTMENTAL KNEE PHASE 3 RIGHT MEDIAL TIBIAL TRAY STD SZ C PROSTHESIS, KNEE NRA BIOMET UK LTD N/A 380512

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R