BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNICOMPARTMENTAL KNEE PHASE 3 FEMORAL SIZE SMALL

    MDR report key: 1913027 · Received December 2, 2010

    Report

    Report Number
    1825034-2010-00637
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    June 24, 2008
    Report Date
    November 3, 2010
    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: POSSIBLE ADVERSE EFFECT #20 - PERSISTENT PAIN. THE DEVICE IS IN A CLINICAL STUDY AND NOT AVAILABLE FOR EVALUATION. THIS REPORT FILED (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2007 AS PART OF A CLINICAL STUDY. SUBSEQUENTLY, PATIENT BEGAN TO EXPERIENCE PAIN AND A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2008. THE FEMORAL COMPONENT, TIBIAL TRAY AND MENISCAL BEARING WERE REMOVED AND REPLACED. 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 FEMORAL SIZE SMALL PROSTHESIS, KNEE NRA BIOMET UK LTD N/A 285564

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R