BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SP2 TIBIAL RADEL IMPACTOR

    MDR report key: 3943244 · Received July 18, 2014

    Report

    Report Number
    1818910-2014-23697
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. THE INITIAL REPORT STATED THE DEVICE WOULD BE RETURNED. FOLLOW UP COMMUNICATION FOR PRODUCT RETURN WAS UNSUCCESSFUL. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED BREAKAGE BASED ON THE LACK OF THE PRODUCT TO EXAMINE. BASED ON THE INABILITY TO CONFIRM THE REPORTED EVENT AND THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION IS NOT WARRANTED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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

    TIBIAL IMPACTOR CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421738 SP2 TIBIAL RADEL IMPACTOR KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. J0708

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR