BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - EPOCA

    MDR report key: 23256048 · Received October 9, 2025

    Report

    Report Number
    8030965-2025-10165
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. INVESTIGATION SUMMARY: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH 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 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: 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, A TOTAL OF 43 PATIENTS WERE INCLUDED IN THE STUDY. CONSIST OF 29 MALES & 13 FEMALES; THE MEAN AGE FOR ATSA: 58.8; MEAN AGE FOR RTSA: 65.2)). 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%). FOLLOWED UP WERE UNKNOWN. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SYNTHES EPOCA. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK -EPOCA (QTY 2) .-(N=2) POLYETHYLENE WEAR AND OSTEOLYSIS; INTERVENTION: NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2610753 UNK - EPOCA PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention