BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SROM*STM LG 36+8L 20X15X225R

    MDR report key: 3834478 · Received May 28, 2014

    Report

    Report Number
    1818910-2014-19571
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    DEPUY IRELAND REG. # 9616671
    Product Code
    JDI
    PMA / PMN Number
    PK851422
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. REVIEW OF PROVIDED X-RAYS AND PHOTOGRAPHY CONFIRMS THE REPORTED FEMORAL STEM FRACTURE. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED TWO OTHER REPORTS AGAINST THE 2938010 LOT CODE. THE REPORTS ARE NOT RELATED OR SIMILAR. NO OTHER REPORTS WERE FOUND AGAINST THE REMAINING PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN 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.

    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

    PROCEDURE: HIP REVISION. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2013. REVISION SURGERY WAS PERFORMED ON (B)(6) 2014. HIP WAS REVISED BECAUSE THE DISTAL PART OF THE STEM HAS BROKEN. ADDITIONAL PRIMARY IMPLANTS WERE LIMA 62MM CUP AND INSERT. COMPONPRE-OP X-RAY AND PHOTO OF THE EXPLANTED STEM ARE AVAILABLE. PATIENT INITIALS AND DOB ARE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314153 SROM*STM LG 36+8L 20X15X225R HIP FEMORAL STEM/SLEEVE JDI DEPUY IRELAND REG. # 9616671 3140583

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR