BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA CRVD INSERT SZ3 8MM

    MDR report key: 1033566 · Received April 23, 2008

    Report

    Report Number
    1818910-2008-01118
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 24, 2008
    Manufacturer
    DEPUY - RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC
    Product Code
    HSH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS A PAINFUL RIGHT KNEE. A 8MM CURVED INSERT WAS REPLACED WITH A 10MM CURVED INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA CRVD INSERT SZ3 8MM NONE HSH DEPUY - RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC NA 59603A

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention