BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LPS FEM TO SLEEVE ADAPTER +5

    MDR report key: 4192340 · Received October 22, 2014

    Report

    Report Number
    1818910-2014-30392
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK040281
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 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 THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS INFECTION. DURING THE CASE, THE DISTAL FEMORAL COMPONENT AND LPS SLEEVE ADAPTER "CAME OUT OF THE SURGICAL WOUND." (B)(6) STATES LOOSENING, BUT FOLLOW-UP DISCUSSIONS WITH REP INDICATE DISASSOCIATION. BOTH COMPONENTS WERE AUTOCLAVED AND REIMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674247 LPS FEM TO SLEEVE ADAPTER +5 KNEE OTHER IMPLANT JWH DEPUY ORTHOPAEDICS, INC. 378268

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention