BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL LID

    MDR report key: 24909393 · Received April 17, 2026

    Report

    Report Number
    1818910-2026-07025
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    March 16, 2026
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    FSM
    UDI-DI
    10603295422471
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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 (AND/OR PART 4, AS APPLICABLE). 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE.

    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. H11 ADDITIONAL NARRATIVE: ADDED: D9. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CASE 2, CASE 2 TRAY 1, UNIVERSAL LID, CASE 1, AND CASE 1 TRAY 1 WERE ASSOCIATED WITH SHOULDER EXTRACTION CASES EXHIBITING FLAKING PAINT CHIPS AND PLASTIC, WHICH WERE DEEMED UNACCEPTABLE BY SPD STANDARDS. THE EVENT INVOLVED MULTIPLE INSTRUMENT CASES AND TRAYS, WITH THE REPORTED ISSUE BEING THE PEELING OF NYLON/PLASTIC COATING FROM THE CASE/MODULE, POTENTIALLY PRODUCING CHIPS, FLAKES, OR DEBRIS. THERE WAS NO PATIENT INVOLVEMENT OR OBSERVABLE CLINICAL SYMPTOMS, AND NO CONSEQUENCES OR IMPACT TO THE PATIENT WERE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521311 UNIVERSAL LID INSTRUMENT CASES FSM DEPUY ORTHOPAEDICS INC US 10603295422471

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Unknown