BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA PS CEM FEM SZ3 R

    MDR report key: 3033372 · Received April 3, 2013

    Report

    Report Number
    1818910-2013-14785
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    DEPUY (IRELAND) 9616671
    Product Code
    JWH
    PMA / PMN Number
    PK073529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODE REQUIRED WAS NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4). PATIENT OPERATIVE REPORTS AND X-RAYS WERE RECEIVED. REVIEW OF THE SUPPLIED INPUTS CONFIRMED OSTEOLYSIS AND DEBONDING BETWEEN THE CEMENT AND DEVICE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE ROOT CAUSE OF THE OSTEOLYSIS OR DEVICE DEBONDING WITH INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF PAIN, OSTEOLYSIS, AND LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137217 SIGMA PS CEM FEM SZ3 R INSERT JWH DEPUY (IRELAND) 9616671 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention