BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA C/S NPOR FEM LT SZ 4

    MDR report key: 1864399 · Received October 6, 2010

    Report

    Report Number
    1818910-2010-07234
    Event Type
    Injury
    Date Received
    October 6, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 22, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K950010
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. THE REPORTED DEVICES ARE MANUFACTURED FROM COBALT CHROME MATERIAL, WHICH CONTAIN ELEMENTS OF NICKEL. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE PRODUCT LOT CODES. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND 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, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT REVISED FOR METAL ALLERGY TO NICKLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA C/S NPOR FEM LT SZ 4 87 JWH JWH DEPUY ORTHOPAEDICS, INC. NA 117044HB

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention