BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLAP HAMMER M6/M10 ADAPTATOR

    MDR report key: 3853153 · Received June 6, 2014

    Report

    Report Number
    1818910-2014-20385
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE FOR AS THE LOT CODE REQUIRED WAS NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4) APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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.

    Description of Event or Problem · 1

    RELATED CASE (B)(4). DURING TOTAL HIP REPLACEMENT REVISION, THE CORAIL EXTRACTION INSTRUMENT SNAPPED OFF IN THE STEM, THEREFORE, THE SURGEON COULD NOT USE THE EXTRACTION INSTRUMENT TO REMOVE THE STEM FROM THE BODY. SURGEON PROCEEDED BY USING A MOLEWRENCH FLAT HAMMER AND AN SROM STEM EXTRACTOR AND SPLIT THE FEMUR IN ORDER TO REMOVE THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332693 SLAP HAMMER M6/M10 ADAPTATOR HIP INSTRUMENT/TRIAL LXH DEPUY FRANCE SAS 3003895575 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention