BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNICOMPARTMENTAL KNEE PHASE 3 TIBIAL TRAY WIDE 41 X 26MM

    MDR report key: 1992137 · Received February 15, 2011

    Report

    Report Number
    1825034-2011-00108
    Event Type
    Injury
    Date Received
    February 15, 2011
    Report Date
    January 19, 2011
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6) 2011. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED FROM THE USER FACILITY. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    PATIENT REPORTED THAT PARTIAL KNEE ARTHROPLASTY WAS PERFORMED IN 2003 OR 2004 AND SUBSEQUENT REVISION TO A TOTAL KNEE OCCURRED. THE REASON FOR THE REVISION, THE DATES OF AND LOCATIONS OF BOTH PROCEDURES WAS NOT COMMUNICATED. A REVIEW OF INVOICE HISTORY REVEALED THAT THE PARTIAL KNEE WAS IMPLANTED ON (B)(6) 2006. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXFORD UNICOMPARTMENTAL KNEE PHASE 3 TIBIAL TRAY WIDE 41 X 26MM PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 1101545

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R