BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INHANCE

    MDR report key: 25314808 · Received May 28, 2026

    Report

    Report Number
    1818910-2026-09328
    Event Type
    Injury
    Date Received
    May 28, 2026
    Date of Event
    May 28, 2025
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    PHX
    UDI-DI
    10603295547112
    PMA / PMN Number
    K212737
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE.

    Description of Event or Problem · 0

    SUBJECT ID: (B)(6), STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR NON-DISPLACED LESSER TUBEROSITY FRACTURE ON AXILLARY VIEW DEVICE RELATED: POSSIBLE PROCEDURE RELATED: POSSIBLE DATE OF EVENT: 28 MAY 2025 DATE OF IMPLANT: (B)(6) 2025 DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: LEFT. TREATMENT/IMPACT: OBSERVATION DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 520002032 LOT NUMBER: 58471 COMPONENT TYPE: STEM DESCRIPTION: INHANCE SHOULDER SYSTEM STANDARD STEM SMALL Ø32MM X 109MM. CATALOG NUMBER: 550300500 LOT NUMBER: 230242 COMPONENT TYPE: SCREW DESCRIPTION: INHANCE SHOULDER SYSTEM SELF-DRILLING & LOCKING SCREW 4 PACK 20MM & 25MM. CATALOG NUMBER: 550011240 LOT NUMBER: 663948 COMPONENT TYPE: BASEPLATE DESCRIPTION: INHANCE SHOULDER SYSTEM MODULAR UNITI PLATFORM BASEPLATE SMALL Ø24MM CEMENTLESS. CATALOG NUMBER: 550035600 LOT NUMBER: 226421 COMPONENT TYPE: SCREW DESCRIPTION: INHANCE SHOULDER SYSTEM CENTRAL SCREW Ø6.0 X 35MM. CATALOG NUMBER: 550532004 LOT NUMBER: 351203 COMPONENT TYPE: GLENOSPHERE DESCRIPTION: INHANCE SHOULDER SYSTEM GLENOSPHERE Ø32+4MM. CATALOG NUMBER: 550000320 LOT NUMBER: 664124 COMPONENT TYPE: SHELL DESCRIPTION: INHANCE SHOULDER SYSTEM REVERSE HUMERAL SHELL SMALL Ø32+0MM. CATALOG NUMBER: 550032100 LOT NUMBER: MI124845 COMPONENT TYPE: LINER DESCRIPTION: INHANCE SHOULDER SYSTEM REVERSE LINER RETENTIVE X-LINKED VITAMIN E PE Ø32+0MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409739 INHANCE SHOULDER IMPLANT - HUMERAL STEM PHX DEPUY IRELAND - 3015516266 10603295547112

    Patients

    Seq Age Sex Outcome Treatment
    1