BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZTT, 16D-SML

    MDR report key: 3942087 · Received July 17, 2014

    Report

    Report Number
    1818910-2014-23675
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    October 7, 2008
    Report Date
    June 18, 2014
    Manufacturer
    DEPUY INTL., LTD.8010379
    Product Code
    LPH
    PMA / PMN Number
    PK934412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL REPORT STATES THAT THE PATIENT WAS REVISED, MIGRATION/LOOSENING ¿ STEM WERE NOTED. EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THAT THE PATIENT WAS REVISED, MIGRATION/LOOSENING ¿ STEM WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418377 S-ROM*SLEEVE PRX ZTT, 16D-SML HIP FEMORAL STEM/SLEEVE LPH DEPUY INTL., LTD.8010379 1117949

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention