BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCS COMPLETE REV FEM TRL L LG

    MDR report key: 10052547 · Received May 13, 2020

    Report

    Report Number
    1818910-2020-12038
    Event Type
    Malfunction
    Date Received
    May 13, 2020
    Date of Event
    April 30, 2020
    Report Date
    April 30, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LXH
    UDI-DI
    10603295113133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE:  ADDED DEVICE IDENTIFICATION (LOT#). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE:  ADDED DEVICE IDENTIFICATION (LOT), CONCOMITANT MEDICAL PRODUCTS AND DEVICE MANUFACTURE DATE. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED DEVICES CONFIRMED THE REPORTED EVENT. THE ROOT CAUSE IS ATTRIBUTED TO MIS-USE. THE DEVICE WAS MANUFACTURED ON MANUFACTURED ON (B)(6) 2008. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    SURGEON WAS UNABLE TO CONNECT THE SAMPLE SLEEVE TO THE SAMPLE FEMUR WITH THE USE OF SCREW: 217861100. ALLEGATION AGAINST THE SCREW 217861100. PATIENT: MALE, (B)(6). SURGERY DELAY: 20MIN. NO ADVERSE PATIENT HARM. SURGERY PERFORMED: MBT REVISION AND LCS VVC BY LYING SPACER. SURGERY SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514700 LCS COMPLETE REV FEM TRL L LG KNEE INSTRUMENT : FEMORAL TRIALS LXH DEPUY ORTHOPAEDICS INC US 2294-29-060 AF0208 10603295113133

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR