BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LPS DSTL FEM TRL LO PROFILE RT

    MDR report key: 15797070 · Received November 15, 2022

    Report

    Report Number
    1818910-2022-22919
    Event Type
    Malfunction
    Date Received
    November 15, 2022
    Date of Event
    August 18, 2022
    Report Date
    November 15, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LXH
    UDI-DI
    10603295157830
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED 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. 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

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE REPORTED EVENT WITHOUT THE DEVICE TO EXAMINE. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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 · 0

    DR USED A LPS DISTAL FEMORAL REPLACEMENT FOR A REVISION OF A PERI PROSTHETIC FRACTURE (NOT A J&J PRODUCT) IN (B)(6) 2022. HE USED A LPS DISTAL FEMUR WITH SLEEVE ADAPTOR AND UNIVERSAL STEM AND SLEEVE FOR THE FEMORAL IMPLANT COMBINATION. I HAVE BEEN INFORMED THAT THERE WERE CHALLENGES SEPARATING THE 10MM SLEEVE ADAPTOR FROM THE LPS DISTAL FEMORAL TRIAL DURING KIT DECONTAMINATION, AND THAT THE AFFECTED INSTRUMENTS WERE SENT BACK TO THE WA WAREHOUSE FOR COMPLETE SEPARATION FOLLOWING THE HOSPITALS DECONTAMINATION PROCEDURE. I AM NOW BEING TOLD BY THE WA WAREHOUSE THAT THE 10MM ADAPTOR BOLT IS MISSING, AND THAT IT WAS NEVER RETURNED FROM THE HOSPITAL WHICH CONTRADICTS THE COMPLAINT OF THE ADAPTOR BOLT BEING STUCK IN THE TRIAL FEMUR. THERE HAS BEEN A COMPLETE SEARCH OF THE HOSPITAL SSD AND THE "MISSING" ADAPTOR CAN NOT BE LOCATED THERE. THE WA WAREHOUSE RECEIVABLES TEAM NEED TO DO A FULL SEARCH OF THE RETURNS AREA OR PC INSTRUMENT HOLD AREA FOR THESE PRODUCTS FOR FURTHER FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020834 LPS DSTL FEM TRL LO PROFILE RT HIP INSTRUMENTS : FEMORAL TRIALS LXH DEPUY ORTHOPAEDICS INC US 2987-14-105 AE0705 10603295157830

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown