BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZT HA 16D-LRG

    MDR report key: 3105227 · Received May 10, 2013

    Report

    Report Number
    1818910-2013-16920
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    9616671 DEPUY IRELAND
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    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. REVIEW OF DEVICE HISTORY RECORDS BY DEPUY CORK FINDS PRODUCT CODE 1803511 , WORK ORDER 528330 WAS MANUFACTURED ON 09 SEPTEMBER 2004. 30 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. REVIEW OF PROVIDED PATIENT X-RAYS FINDS HERE ARE NOTED CABLES AROUND THE PROXIMAL FEMUR SIGNIFYING THE POSSIBILITY OF A PERIPROSTHETIC FRACTURE. NO EXTREME RADIOLUCENCY NOTED AROUND THE STEM AND SLEEVE INTERFACE, BASED ON THE QUALITY OF THE X-RAY PROVIDED. 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.

    Description of Event or Problem · 1

    REASON FOR REVISION: PATIENT HYPER MOBILE. SROM STEM LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206784 S-ROM*SLEEVE PRX ZT HA 16D-LRG SLEEVE MEH 9616671 DEPUY IRELAND 1815362

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention