BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA C/R NPOR FEM RT SZ4

    MDR report key: 609862 · Received June 2, 2005

    Report

    Report Number
    1818910-2005-00821
    Event Type
    Injury
    Date Received
    June 2, 2005
    Report Date
    May 26, 2005
    Manufacturer
    DEPUY-RAYNAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BONE CEMENT DID NOT ADHERE TO COMPONENTS AND BECAME LOOSE AFTER IMPLANTATION. NO HARM TO PT. DELAYED SURGERY (1) HOUR. INFORMATION WAS RECEIVED 05/2005, THAT PRODUCTS COULD ALSO HAVE CONTRIBUTED TO EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA C/R NPOR FEM RT SZ4 TOTAL KNEE REPLACEMENT JWH DEPUY-RAYNAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA 045014BD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention