BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLOBAL UNITE REV STEM SZ 8

    MDR report key: 20388680 · Received October 7, 2024

    Report

    Report Number
    1818910-2024-21000
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    October 1, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HSD
    UDI-DI
    10603295004059
    PMA / PMN Number
    K170748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. PRODUCT DESCRIPTION:- GLOBAL UNITE REV STEM SZ 8. PRODUCT CODE:- 110008600. LOT NO:- 4110628. QUANTITY OF MANUFACTURED:- (B)(4). DATE OF MANUFACTURING:- 24-MAR-2023. EXPIRY DATE:- 28-FEB-2033. 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 ==> PRODUCT DESCRIPTION:- GLOBAL UNITE REV STEM SZ 8. PRODUCT CODE:- 110008600. LOT NO:- 4110628. QUANTITY OF MANUFACTURED:- (B)(4). DATE OF MANUFACTURING:- 24-MAR-2023. EXPIRY DATE:- 28-FEB-2033. DEVICE HISTORY REVIEW ==> A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A RIGHT SHOULDER SURGERY ON (B)(6) 2024, THE STEM LABELING WAS MISLEADING. 8 LONG INSTEAD OF 8 STD WAS OPENED. THERE WAS NO ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247941 GLOBAL UNITE REV STEM SZ 8 GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS HSD DEPUY ORTHOPAEDICS INC US 4110628 10603295004059

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female