BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNICOMPARTMENTAL KNEE PHASE 3 FEMORAL SIZE SMALL

    MDR report key: 2071848 · Received April 28, 2011

    Report

    Report Number
    1825034-2011-00308
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    November 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 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: "PERSISTENT PAIN". THIS REPORT FILED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PARTIAL KNEE ARTHROPLASTY ON (B)(6), 2008 AS PART OF A CLINICAL STUDY. SUBSEQUENTLY, THE PATIENT EXPERIENCED CONTINUED PAIN AND A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2008. THE FEMORAL COMPONENT, TIBIAL TRAY AND TIBIAL BEARING WERE ALL REMOVED AND REPLACED WITH TOTAL KNEE COMPONENTS. NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXFORD UNICOMPARTMENTAL KNEE PHASE 3 FEMORAL SIZE SMALL PROSTHESIS, KNEE NRA BIOMET UK LTD N/A 470317

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R