BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SP*2 FEMORAL IMPACTOR

    MDR report key: 3994135 · Received August 8, 2014

    Report

    Report Number
    1818910-2014-25275
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 5, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. 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 SP*2 FEMORAL IMPACTOR ASSOCIATED WITH THE REPORTED EVENT WAS NOT RETURNED. THE PRODUCT LOT CODE REQUIRED TO IDENTIFY THE MANUFACTURE DATE/DESIGN REVISION WAS NOT PROVIDED. A SEARCH OF THE COMPLAINT DATABASE FOUND PREVIOUS REPORTS OF SP*2 FEMORAL IMPACTOR DAMAGE. THE PREVIOUS REPORTS WERE INVESTIGATED AND THE ROOT CAUSE ATTRIBUTED TO PRODUCT WEAR OUT. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE CURRENT REPORTED EVENT WITHOUT THE INSTRUMENT TO EXAMINE. 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.

    Description of Event or Problem · 1

    TKR: HALF WAY THROUGH THE PROCEDURE AND DURING USE ON PATIENT, THE INSTRUMENT BROKE WHILE THE SURGEON WAS USING IT. MANAGED BY USING SAME LIKE PRODUCT. NO DELAY TO SURGERY. NO AE TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467623 SP*2 FEMORAL IMPACTOR KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1