BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC C/R FEM POR LFT SZ4

    MDR report key: 323326 · Received March 30, 2001

    Report

    Report Number
    1818910-2001-00113
    Event Type
    Injury
    Date Received
    March 30, 2001
    Date of Event
    October 23, 2000
    Report Date
    March 30, 2001
    Manufacturer
    DEPUY-RAYNHAM/A DIV OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MEDIAL CONDYLE HAD FRACTURED OFF OF THE 96-0024 LEFT SIZE 4 FEMORAL; AND THAT THERE WAS SEVERE POLY WEAR (OF THE UNIDENTIFIED TIBIAL BEARING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14349 PFC C/R FEM POR LFT SZ4 TOTAL KNEE PROSTHESIS JWH DEPUY-RAYNHAM/A DIV OF DEPUY ORTHOPAEDICS, INC. NA 795DF

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention