BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATN LAG SCREW 110MM STERILE

    MDR report key: 1040452 · Received May 8, 2008

    Report

    Report Number
    1818910-2008-01341
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 16, 2008
    Report Date
    April 23, 2008
    Manufacturer
    DEPUY ACE S.A. R.L.
    Product Code
    HSB
    PMA / PMN Number
    K042325
    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. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR BOTH REPORTED PART AND LOT NUMBER COMBINATIONS. REVIEW OF THE DEVICE HISTORY RECORDS BY LELOCLE FOUND NO DISCREPANCIES. ALTHOUGH THE COMPLAINT IS NON-VERIFIABLE, INITIAL IMPLANT PLACEMENT AND BONE QUALITY ARE CONTRIBUTING FACTORS. ALSO, THE SURGICAL TECHNIQUE FOR THE ATN SYSTEM RECOMMENDS TAPPING OF THE FEMORAL HEAD BEFORE INSERTION OF THE LAG SCREW. THE ATN LAG SCREW IS NOT SELF-TAPPING. IF THE FEMORAL HEAD IS NOT TAPPED BEFORE LAG SCREW INSERTION, THE LAG SCREW FORCES THE BONE IN THE FEMORAL HEAD TO BE PUSHED AWAY FROM THE LAG SCREW THREAD. THE THREADS WILL NOT PURCHASE INTO THE BONE AND THERE IS NOT ADEQUATE SUPPORT TO HOLD THE LAG SCREW IN THE FEMORAL HEAD. IF THE LAG SCREW IS INADEQUATELY FIXED INTO THE FEMORAL HEAD LAG SCREW BACKOUT CAN OCCUR. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD THE PRODUCT AND/OR ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    IT WAS FOUND THAT THE LAG SCREW WAS BACKED OUT TWO MONTHS AND A HALF AFTER THE SURGERY. THE PT HAD A PAIN. ANOTHER SURGERY WAS DONE TO REMOVE THE LAG SCREW OUT OF THE PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATN LAG SCREW 110MM STERILE 87HSB HSB DEPUY ACE S.A. R.L. NA DFDCJM

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention