BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANCE CALCAR SZ3 200MM

    MDR report key: 16370749 · Received February 14, 2023

    Report

    Report Number
    1818910-2023-03613
    Event Type
    Injury
    Date Received
    February 14, 2023
    Date of Event
    January 1, 2023
    Report Date
    February 14, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    UDI-DI
    10603295057338
    PMA / PMN Number
    K961619
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). COMPONENT CODE: APPROPRIATE TERM/CODE NOT AVAILABLE (G07002) USED TO CAPTURE NO FINDINGS AVAILABLE. INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. 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

    IT WAS REPORTED THAT PATIENT HAD A TOTAL LEFT HIP ARTHOPLASTY DONE (B)(6) 2021. ("TOTAL HIP PACKAGE LEFT FEMORAL STEM 12/14 TAPER ENDURANCE HIP SIZE 3 1521 62 000 DEPUY SNA"). THE CEMENT FELL OUT("2/3RDS OF IT FROM BOTTOM UP"). END OF STEM GOUGING 2 NOTCHES INSIDE FEMORAL. CHRONIC PAIN. RALLY MY AB CEMENT WAS USED. NOW THEY WANT TO DO IT ALL OVER AGAIN, WITH NO GUARANTEE IT WON'T HAPPEN AGAIN. SURGEON IS VERY VAGUE ON HIS PLAN OF ATTACK, WHEN ASKED IF HE IS GOING TO USE A PRESS IN STEM THIS TIME, OR CEMENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810708 ENDURANCE CALCAR SZ3 200MM MISCELLANEOUS HIP STEM : HIP FEMORAL STEM JDI DEPUY ORTHOPAEDICS INC US 1521-62-000 10603295057338

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention