BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNEE OTHER IMPLANT

    MDR report key: 5900301 · Received August 24, 2016

    Report

    Report Number
    1818910-2016-25821
    Event Type
    Malfunction
    Date Received
    August 24, 2016
    Date of Event
    August 12, 2016
    Report Date
    August 12, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HXC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 AS THE PRODUCT LOT CODE REQUIRED WAS NOT PROVIDED. A SEARCH OF THE COMPLAINT DATABASE AGAINST PRODUCT CODE (B)(4) FOUND ADDITIONAL REPORTS OF SIGMA FEM ADAPTER 5 DEGREE GETTING STUCK ON THE SIG FEM ADPT TORQUE WRENCH. THE PREVIOUS INVESTIGATIONS ATTRIBUTED THE ROOT CAUSE TO PRODUCT DESIGN. CO (B)(4) WAS RELEASED (B)(6) 2015 TO CHANGE THE DESIGN OF PRODUCT CODE (B)(4) AS PART OF CAPA 000509. THE CURRENT COMPLAINT SAMPLE WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF CO (B)(4). NO FURTHER CORRECTIVE ACTION REQUIRED. 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.

    Description of Event or Problem · 1

    THE FEMORAL ADAPTER WRENCH GOT STUCK ON THE FEMORAL ADAPTER, SCRATCHING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553505 KNEE OTHER IMPLANT KNEE INSTRUMENT/TRIAL HXC DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR