BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC TOTAL KNEE SYSTEM OVAL PATELLA

    MDR report key: 358047 · Received October 23, 2001

    Report

    Report Number
    1818910-2001-00356
    Event Type
    Malfunction
    Date Received
    October 23, 2001
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ABNORMAL POLY WEAR WAS REPORTED TO DEPUY FRANCE WITH NO PATIENT INFORMAITON. UNKNOWN IF REVISION HAS TAKEN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47465 PFC TOTAL KNEE SYSTEM OVAL PATELLA TOTAL KNEE PROSTHESIS JWH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA 523CN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention