BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLENOSPHERE INSERTER TIP

    MDR report key: 18889103 · Received March 12, 2024

    Report

    Report Number
    1818910-2024-05628
    Event Type
    Malfunction
    Date Received
    March 12, 2024
    Date of Event
    March 8, 2024
    Report Date
    March 12, 2024
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    LXH
    UDI-DI
    10603295547266
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A SEARCH OF THE DEPUY NONCONFORMANCE (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT 650011104/LOT 202693 COMBINATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT A SEARCH OF THE DEPUY NONCONFORMANCE (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT 650011104/LOT 202693 COMBINATION.

    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. H10 ADDITIONAL NARRATIVE: ADDED: B5. 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). 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

    ADDITIONAL INFORMATION WAS RECEIVED: NO SURGERY DELAY. NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GLENOSPHERE INSERTION TIP STRIPPED OUT AND NEEDS TO BE REPLACED. SURGICAL DELAY WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029521 GLENOSPHERE INSERTER TIP SHOULDER INSTRUMENT - INSERTION DEVICE LXH DEPUY IRELAND - 3015516266 202693 10603295547266

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown