BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA PS CEM FEM SZ2.5 L

    MDR report key: 3181273 · Received June 21, 2013

    Report

    Report Number
    1818910-2013-19472
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    February 2, 2009
    Report Date
    May 28, 2013
    Manufacturer
    8010379 DEPUY INTL., LTD.
    Product Code
    JWH
    PMA / PMN Number
    PK073529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED AND IS PRESUMED TO REMAIN IMPLANTED AS NO REVISION HAS BEEN REPORTED. PATIENT X-RAYS WERE NOT AVAILABLE FOR EXAMINATION. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS 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 THERE WAS AN INTRAOPERATIVE COMPLICATION OF A POPLITEAL ARTERY INJURY. THE ARTERY WAS REPAIRED INTRAOPERATIVELY BY A VASCULAR SUGERON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282488 SIGMA PS CEM FEM SZ2.5 L FEMORAL JWH 8010379 DEPUY INTL., LTD. C5XAN4

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention