BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SHOULDER PROXIMAL BODY GLOBAL

    MDR report key: 22335733 · Received June 26, 2025

    Report

    Report Number
    1818910-2025-10627
    Event Type
    Injury
    Date Received
    June 26, 2025
    Date of Event
    January 1, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED. 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: THE DEVICE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED.

    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: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: HONOKI K. ET AL. A SECULAR RADIOGRAPHIC CHANGE AROUND UNCEMENTED HUMERAL STEM AFTER SHOULDER ARTHROPLASTY - MORE THAN 8 YEARS FOLLOW-UP. SEMINARS IN ARTHROPLASTY 34 (2024) 197-202. HTTPS://DOI.ORG/10.1053/J.SART.2023.10.005. (PUBMED CITATION NOT AVAILABLE) OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE CHRONOLOGICAL RADIOGRAPHIC CHANGES TO THE HUMERUS IN THE LONG TERM AFTER UNCEMENTED SHOULDER ARTHROPLASTY. THIS RETROSPECTIVE CASE-SERIES STUDY WAS APPROVED BY THE INSTITUTIONAL REVIEW BOARD (IRB) OF HOKUSHIN ORTHOPAEDIC HOSPITAL (APPROVAL NO. 2301). SUBJECTS COMPRISED 24 PATIENTS WHO UNDERWENT TOTAL SHOULDER ARTHROPLASTY (TSA; N=14) OR HUMERAL HEAD REPLACEMENT (HHR; N=10) BETWEEN 2005 AND 2012 AND WERE ABLE TO BE FOLLOWED UP FOR =8 YEARS. ALL ARTHROPLASTIES WERE PERFORMED USING A SINGLE UNCEMENTED STANDARD HUMERAL STEM (GLOBAL ADVANTAGE; DEPUY, WARSAW, IN, USA). THE MEAN FOLLOW-UP WAS 10.7 ± 1.6 YEARS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES GLOBAL ADVANTAGE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER HUMERAL STEM GLOBAL AND UNK SHOULDER PROXIMAL BODY GLOBAL (QTY 2): 2 CASES HAD LOOSENING OF THE STEM. NO INTERVENTION NOTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER CONSTRUCT GLOBAL (QTY 19): (N=14) SCLEROSIS AT THE TIP OF THE STEM; INTERVENTION NOT PROVIDED. (N=1) GRADE 4 BONE RESORPTION IN THE PROXIMAL AREA AT 2 YEARS. NO INTERVENTION NOTED. (N=3) GRADE 1 BONE RESORPTION IN THE PROXIMAL AREA AT 2 YEARS, WHICH DISAPPEARED AT FINAL FOLLOW-UP. NO INTERVENTION NOTED. (N=1) GRADE 3 BONE RESORPTION IN THE PROXIMAL AREA AT 2 YEARS WHICH PROGRESSED TO GRADE 4 AT FINAL FOLLOW-UP WITHOUT LOOSENING. NO INTERVENTION NOTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER CONSTRUCT GLOBAL (QTY 1): - IN 76-YEAR-OLD MALE PATIENT, DISTAL RLL TURNED TO DISTAL SCLEROSIS. NO INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175397 UNK SHOULDER PROXIMAL BODY GLOBAL SHOULDER PROXIMAL BODY HSD DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention