BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLOBAL UNITE FX RSA EPI CENTER

    MDR report key: 23478940 · Received November 5, 2025

    Report

    Report Number
    1818910-2025-19188
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 17, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    PHX
    UDI-DI
    10603295444749
    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 FOUND NOTHING INDICATIVE OF A DEVICE NONCONFORMANCE. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 4830638 LOT NUMBER, AND ONE NON-CONFORMANCES WAS IDENTIFIED, NO RELATED TO THE REPORTED FAILURE MODE OF THIS COMPLAINT. ALTHOUGH NO DAMAGE WAS OBSERVED ON THE GLOBAL UNITE FX RSA EPI CENTER THE OVERALL WAS CONFIRMED AS THE OBSERVED CONDITION ON THE STEM WOULD HAVE CONTRIBUTED TO COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS REQUIRED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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: 24-JUN-2025. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: ONE NON CONFORMANCE NOT RELATED TO FAILURE MODE OF CURRENT COMPLAINT. 4) EXPIRY DATE: 5-31-2035. 5) IFU REFERENCE: IFU-0902-00-850. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 4830638 LOT NUMBER, AND ONE NON-CONFORMANCES WAS IDENTIFIED, NO RELATED 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: D9, D10 CONCOMITANT, H4. CORRECTED: 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: KREISKRANKENHAUS GELNHAUSEN HERZBACHWEG 14

    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
    2692957 GLOBAL UNITE FX RSA EPI CENTER SHOULDER HUMERAL STEM ACCESSORY PHX DEPUY ORTHOPAEDICS INC US 4830638 10603295444749

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown