BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK SHOULDER HUMERAL CUP DELTA XTEND

    MDR report key: 23191801 · Received October 1, 2025

    Report

    Report Number
    1818910-2025-16881
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Date of Event
    April 30, 2025
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    PHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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. H11 ADDITIONAL NARRATIVE: ADDED: D4 (CATALOG).

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

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: FISHER B, ASTOLFI M, DESLAURIER J, CHILDERS K, LEE JYJ, SAMANI M, DECLERCQ M, WIATER JM. POLYETHYLENE WEAR: AN UNDER-REPORTED CAUSE OF FAILED SHOULDER ARTHROPLASTY. JSES INT. 2025 APR 30;9(4):1293-1302. DOI: 10.1016/J.JSEINT.2025.04.002. PMID: 40959024; PMCID: PMC12435049. OBJECTIVE/METHODS/STUDY DATA THE GOAL OF THIS STUDY WAS TO DESCRIBE THE CLINICAL, RADIOGRAPHIC, AND INTRAOPERATIVE FEATURES OF A SERIES OF ANATOMIC TOTAL SHOULDER ARTHROPLASTY (ATSA) AND REVERSE TOTAL SHOULDER ARTHROPLASTY (RTSA) PATIENTS WHO PRESENTED WITH PE WEAR. BETWEEN 2018 AND 2024, 43 PATIENTS (29 MALES & 13 FEMALES; MEAN AGE FOR ATSA: 58.8; MEAN AGE FOR RTSA: 65.2)) WERE INCLUDED IN THIS STUDY. FOR THE ATSA, THE IMPLANTS USED WERE ZIMMER BIGLIANI-FLATOW 6 (27.3%) ZIMMER TM, 8 (36.4%); ZIMMER NANO STEMLESS, 1 (4.5%); BIOMET COMPREHENSIVE, 2 (9.1%); DEPUY GLOBAL, 2 (9.1%); SYNTHES EPOCA, 2 (9.1%); AND CATALYST ANATOMIC STEMLESS, 1 (4.5%). FOR THE RTSA, IMPLANTS USED WERE ZIMMER TM REVERSE ALONE,13 (59.1%) BIOMET COMPREHENSIVE REVERSE, 2 (9.5%); DJO ENCORE, 1 (4.8%); DEPUY DELTA REVERSE, 1 (4.8%) ZIMMER TM STEM + DJO ENCORE GLENOSPHERE, 3 (14.3%); ZIMMER TM STEM WITH BIOMET GLENOSPHERE, 1 (4.8%). THE MEAN FOLLOW-UP PERIOD IS UNKNOWN. LOT, MODEL AND CATALOG NUMBERS ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY GLOBAL & DEPUY DELTA REVERSE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER CONSTRUCT GLOBAL (QTY 2): (N=2) HUMERAL OSTEOLYSIS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER CONSTRUCT DELTA XTEND (QTY 1): (N=1) HUMERAL OSTEOLYSIS & GLENOID OSTEOLYSIS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER GLENOID GLOBAL (QTY 2): (N=2) POLYETHYLENE WEAR. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER HUMERAL CUP DELTA XTEND (QTY 1): (N=1) POLYETHYLENE WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2154650 UNK SHOULDER HUMERAL CUP DELTA XTEND SHOULDER HUMERAL CUP PHX DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown