BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM 16X11X150 STD 36+6 LAT

    MDR report key: 2854061 · Received December 3, 2012

    Report

    Report Number
    1818910-2012-28485
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 28, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    LPH
    PMA / PMN Number
    K954935
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 RETURNED DEVICE WAS NOT POSSIBLE AS IT WAS NOT RETURNED. IT WAS COMMUNICATED THAT THE DEVICE REMAINS IMPLANTED AND THERE ARE NO PLANS FOR SURGICAL INTERVENTION. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT LOT CODE COMBINATION SINCE ITS RELEASE TO DISTRIBUTION. REVIEW OF PROVIDED PATIENT X-RAYS CONFIRMS THE FRACTURE. ADDITIONALLY, RESEARCH USING THE AS400 SYSTEM INDICATES THAT SEVERAL OTHER DEVICES FROM THE REPORTED LOT HAVE BEEN DELIVERED AND ARE CONSIDERED SUCCESSFULLY IMPLANTED AS NO OTHER REPORTS HAVE BEEN RECEIVED. 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 THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH PAIN IN THE RIGHT HIP, AND AFTER X-RAY IMAGING, IT WAS SHOWN THAT THE STEM WAS FRACTURED DISTALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SROM 16X11X150 STD 36+6 LAT DEPUY HIP IMPLANT LPH DEPUY INTERNATIONAL 2708821

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention