BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATN LAG SCREW 110MM STERILE

    MDR report key: 1770287 · Received July 21, 2010

    Report

    Report Number
    1818910-2010-04721
    Event Type
    Injury
    Date Received
    July 21, 2010
    Date of Event
    June 21, 2010
    Report Date
    June 21, 2010
    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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. ALTHOUGH THE EXACT ROOT CAUSE COULD NOT BE DETERMINED, INITIAL IMPLANT PLACEMENT AND BONE QUALITY ARE CONTRIBUTING FACTORS. THE EXACT ROOT CAUSE COULD NOT BE DETERMINED WITHOUT THE PRE AND POST OP X-RAYS. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THIS PART AND LOT NUMBER COMBINATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD 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

    PT WAS REVISED TO ADDRESS FEMORAL HEAD COLLAPSE.

    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 DJHBV6

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention