BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA CRVD INSERT SZ3 8MM

    MDR report key: 1800863 · Received August 10, 2010

    Report

    Report Number
    1818910-2010-05521
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 19, 2010
    Manufacturer
    DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS
    Product Code
    JWH
    PMA / PMN Number
    K943462
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE PRODUCT LOT CODE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE PRODUCT TO EXAMINE. 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 ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS LOOSENING. POLY WEAR WAS DISCOVERED INTRAOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA CRVD INSERT SZ3 8MM 87JWH JWH DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS NA 1060277

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention