BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTI ROTATION LAG SCREW

    MDR report key: 1152838 · Received September 5, 2008

    Report

    Report Number
    1818910-2008-02937
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 7, 2008
    Manufacturer
    DEPUY ACE S.A. 'R.L.
    Product Code
    HWC
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. THE INVESTIGATION WAS LIMITED TO THE INFO PROVIDED, AS THE LOT NUMBER REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. ALTHOUGH THE COMPLAINT IS NON-VERIFIABLE, INITIAL IMPLANT PLACEMENT INTO THE FEMORAL HEAD AND BONE QUALITY ARE FACTORS GREATLY CONTRIBUTING TO THE CUTOUT RATE. POOR BONE QUALITY OR FEMORAL HEAD COLLAPSE IS A KNOWN AND EXPECTED COMPLICATION. THESE FACTORS ARE COMPLETELY INDEPENDENT OF THE IMPLANT AND CAN POTENTIALLY RESULT IN FAILURE REGARDLESS OF IMPLANT SELECTION. PROVIDED INFO STATES THE LENGTH OF THE LAG SCREW WAS NOT LONG ENOUGH AND COULD NOT SUPPORT THE FEMORAL HEAD, WHICH MIGHT MAKE THE FEMORAL HEAD VARUS AND FEMORAL BONE SHORTENED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY WARSAW CONSIDERS THE INVESTIGATION CLOSED. SHOULD THE PRODUCT AND/OR ANY ADDITIONAL INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    INITIAL SURGERY WAS DONE WITH TROCHANTERIC NAIL SYSTEM FOR FEMORAL NECK FRACTURE. THE DATE OF THE SURGERY IS UNKNOWN. IT WAS NOTED THAT THE ANTI-ROTATION LAG SCREW WAS FOUND CUT OUT AFTER THE SURGERY. ACCORDING TO THE SALES REP, THE LENGTH OF THE LAG SCREW WAS NOT LONG ENOUGH AND COULD NOT SUPPORT THE FEMORAL HEAD, WHICH MIGHT MAKE THE FEMORAL HEAD VARUS AND FEMORAL BONE SHORTENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI ROTATION LAG SCREW TRAUMA DEVICE HWC DEPUY ACE S.A. 'R.L. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA