BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA STAB INS SZ4 12.5MM

    MDR report key: 1170005 · Received September 18, 2008

    Report

    Report Number
    1818910-2008-03945
    Event Type
    Injury
    Date Received
    September 18, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 20, 2008
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K961685
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE AS NO PRODUCT WAS RETURNED. A SEARCH OF THE WARSAW AND INTERNATIONAL COMPLAINT DATABASE DID NOT FIND ANY ADDITIONAL REPORTS OF THIS NATURE FOR THE PRODUCT CODE/LOT PROVIDED SINCE ITS RESPECTIVE RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS 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

    PATIENT REVISED TO ADDRESS FRACTURE OF NATURAL PATELLA, POLYETHYLENE WEAR NOTED AND INSERT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA STAB INS SZ4 12.5MM 87JWH JWH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA 70153A

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention