BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA STAB INS SZ5 10MM

    MDR report key: 1002221 · Received February 20, 2008

    Report

    Report Number
    1818910-2008-00258
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 22, 2008
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K961685
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED EXPLANTED PRODUCTS CONFIRMS THE REPORTED WEAR AND LOOSENING. THE EXACT ROOT CAUSE COULD NOT BE DETERMINED, BUT EVIDENCE INDICATES THE PRESENCE OF THIRD BODY DEBRIS, WHICH WAS LIKELY A CONTRIBUTING FACTOR TO THE POLY WEAR. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF LOOSENING AND WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA STAB INS SZ5 10MM 87JWH JWH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA 41517A

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention