BEUDAMED
    FDA Adverse Event Injury Summary report: N

    14/16 LG TAPER M HEAD 36MM+11

    MDR report key: 3761190 · Received April 21, 2014

    Report

    Report Number
    1818910-2014-17155
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    October 1, 2008
    Report Date
    April 1, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. 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.

    Additional Manufacturer Narrative · 1

    CLINICAL REPORT STATES THAT PATIENT EXPERIENCED HEMORRHAGING FROM POSTERIOR TEAR OF COMMON FEMORAL VEIN DURING PRIMARY THA WHICH WAS TREATED WITH SAPHENOUS VEIN PATCH BY VASCULAR SURGEON.EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES AND/OR A REVIEW OF DEVICE HISTORY RECORDS WERE NOT POSSIBLE AS THE REQUIRED PRODUCT/LOT CODE COMBINATIONS WERE NOT PROVIDED. THE INVESTIGATION CAN DRAW NO CONCLUSION REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THAT PATIENT UNDERWENT REVISION/OPEN REDUCTION OF DISLOCATION 32 DAYS AFTER PRIOR SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240859 14/16 LG TAPER M HEAD 36MM+11 HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other