BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFCSIG CEM FEM STEM5DG15X130MM

    MDR report key: 981533 · Received January 16, 2008

    Report

    Report Number
    1818910-2007-04530
    Event Type
    Injury
    Date Received
    January 16, 2008
    Date of Event
    December 17, 2007
    Report Date
    December 17, 2007
    Manufacturer
    DEPUY-RAYNHAM
    Product Code
    JWH
    PMA / PMN Number
    K952830
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE AS NO PRODUCT WAS RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID NOT FIND ANY ADDITIONAL REPORTS OF THIS NATURE FOR THE PRODUCT CODE/LOTS PROVIDED SINCE THEIR 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 THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFO THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED. SHOULD ADDITIONAL INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. DEPUY CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS PAIN AND INSTABILITY. FEMUR WAS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFCSIG CEM FEM STEM5DG15X130MM 87JWH JWH DEPUY-RAYNHAM NA 315718

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention