BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNICOMPARTMENTAL KNEE PHASE 3 ANATOMIC ARCOM MENISCAL BEARING LG LEFT 5MM

    MDR report key: 2110636 · Received June 1, 2011

    Report

    Report Number
    1825034-2011-00463
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    December 8, 2010
    Report Date
    May 9, 2011
    Manufacturer
    BIOMET UK LTD
    Product Code
    NRA
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. THIS REPORT FILED (B)(6), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT PARTIAL KNEE ARTHROPLASTY ON (B)(6), 2008. SUBSEQUENTLY, PATIENT REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2010 TO REMOVE THE PARTIAL KNEE COMPONENTS. DETAILED EVENT INFORMATION REGARDING THE REVISION WAS NOT PROVIDED. NO FURTHER INFORMATION HAS BEEN SUPPLIED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXFORD UNICOMPARTMENTAL KNEE PHASE 3 ANATOMIC ARCOM MENISCAL BEARING LG LEFT 5MM PROSTHESIS, KNEE NRA BIOMET UK LTD N/A 362102

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R