BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLOBAL UNITE STD STEM SZ 10

    MDR report key: 23478927 · Received November 5, 2025

    Report

    Report Number
    1818910-2025-19187
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 17, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HSD
    UDI-DI
    10603295004080
    PMA / PMN Number
    K170748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: BOTH PRODUCTS COULD NOT BE PROPERLY CONNECTED TO EACH OTHER. THERE WAS A REMAINING GAP OF 2CM. NO APPRECIABLE OP TIME DELAY. NO PATIENT DAMAGE THE PRODUCT WAS RETURNED TO DEPUY SYNTHES CORK SITE FOR A MANUFACTURING INVESTIGATION. VISUAL INSPECTION OF THE RETURNED DEVICE WAS ABLE TO CONFIRM THE REPORTED EVENT, AS THE TAB WIDTH WAS OUT OF SPECIFICATION (TOO WIDE), CONDITION THAT IMPEDES AN INTENDED ASSEMBLY. COMPLAINT UNIT: (B)(4), GLOBAL UNITE STD STEM SZ 10, BATCH 4788075, QUANTITY: 01 IT WAS OBSERVED THAT THE TOP OF THE TAB WAS DAMAGED AND THEREFORE COULD NOT FIT WITH THE RETURNED MATING PART, GLOBAL UNITE REVERSE FX EPI, BATCH: 4830638, QUANTITY: 01. THE ASSIGNABLE CAUSE WAS DEEMED TO BE ¿MAN¿. THIS ASSIGNABLE CAUSE IS ASSOCIATED WITH HUMAN ERROR AS THE INSPECTION OF THE TAB WIDTH WAS NOT CARRIED OUT CORRECTLY. COMPLAINT FAILURE MODE WAS TRACED TO A MALFUNCTION BETWEEN THE MATING DEVICE WITH ITS COUNTERPART. THERE IS NO EXPECTED IMPACT ON THE STERILITY OF UNIT OR THE INTEGRITY OF STERILE BARRIER BASED ON THE COMPLAINT INVESTIGATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 4788075 LOT NUMBER, AND TWO NON-CONFORMANCES WERE IDENTIFIED ASSOCIATED TO THE REPORTED FAILURE MODE OF THIS COMPLAINT. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE GLOBAL UNITE STD STEM SZ 10 WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INFORMATION CURRENTLY AVAILABLE, A PRODUCT ISSUE WAS IDENTIFIED DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH DEPUY SYNTHES QUALITY SYSTEM. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: 1) QUANTITY MANUFACTURED: (B)(4). 2) DATE OF MANUFACTURE: 05-01-2025. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: 2 NON-CONFORMANCES ASSOCIATED TO THE FAILURE MODE OF THIS COMPLAINT. 4) EXPIRY DATE: 4-30-2035. 5) IFU REFERENCE: IFU-0902-00-850. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 4788075 LOT NUMBER, AND TWO NON-CONFORMANCES WERE IDENTIFIED ASSOCIATED TO THE REPORTED FAILURE MODE OF THIS COMPLAINT. ADDED: D10 (CONCOMITANT). CORRECTED: H3.

    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: D4 EXPIRATION DATE, D9, D10 CONCOMITANT, H4, CORRECTED: D4 PRIMARY UDI NUMBER, H8. 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) 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 MANUFACTURER NARRATIVE: E1 INITIAL REPORTER ADDRESS LINE 1:(B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BOTH PRODUCTS COULD NOT BE PROPERLY CONNECTED TO EACH OTHER. THERE WAS A REMAINING GAP OF 2CM. NO APPRECIABLE OP TIME DELAY. NO PATIENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2491660 GLOBAL UNITE STD STEM SZ 10 GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS HSD DEPUY ORTHOPAEDICS INC US 4788075 10603295004080

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GLOBAL UNITE FX RSA EPI CENTER.