BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA/OV DOME PAT 3 PEG,32

    MDR report key: 2071652 · Received April 15, 2011

    Report

    Report Number
    1818910-2011-06499
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    November 8, 2010
    Report Date
    March 18, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K961685
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES PT REVISED FOR METALLOSIS, POLYETHYLENE WEAR AND INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA/OV DOME PAT 3 PEG,32 87 JWH JWH DEPUY ORTHOPAEDICS, INC. NA 182733

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention