BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEMLESS M 36

    MDR report key: 24615744 · Received March 17, 2026

    Report

    Report Number
    1818910-2026-04880
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    February 5, 2026
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    PKC
    UDI-DI
    10603295538257
    PMA / PMN Number
    K203108
    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 MANUFACTURER NARRATIVE: H3, H6: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A RECORDS EVALUATION (MRE) WAS NOT PERFORM 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.

    Description of Event or Problem · 0

    SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED THE PATIENT EXPERIENCED PERSISTENT INSTABILITY IN THE LEFT SHOULDER FOLLOWING A REVERSE TOTAL SHOULDER ARTHROPLASTY, DESPITE INITIAL POSTOPERATIVE IMPROVEMENT. IMAGING CONFIRMED STABLE ALIGNMENT OF THE IMPLANT, AND THE INSTABILITY DID NOT RESULT IN A TRUE GLENOHUMERAL DISLOCATION. PERSISTENT SYMPTOMS LED TO A DIAGNOSTIC CT SCAN TO ASSESS PROSTHESIS STABILITY AND POSITION. DEVICE RELATED: POSSIBLE (HUMERAL STEMLESS IMPLANT: YES) PROCEDURE RELATED: POSSIBLE DATE OF EVENT: 05 FEB 2026 DATE OF IMPLANT: (B)(6) 2025 DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: LEFT. TREATMENT/IMPACT: DIAGNOSTIC INTERVENTION (CT) DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 520000036 LOT NUMBER: 662988 COMPONENT TYPE: HUMERAL DESCRIPTION: INHANCE SHOULDER SYSTEM STEMLESS MEDIUM DIAMETER 36MM CEMENTLESS. CATALOG NUMBER: 550011240 LOT NUMBER: 664496 COMPONENT TYPE: BASEPLATE DESCRIPTION: INHANCE SHOULDER SYSTEM MODULAR UNITI PLATFORM BASEPLATE SMALL Ø24MM CEMENTLESS. CATALOG NUMBER: 550035600 LOT NUMBER: 206439 COMPONENT TYPE: SCREW DESCRIPTION: INHANCE SHOULDER SYSTEM CENTRAL SCREW Ø6.0 X 35MM. CATALOG NUMBER: 550310035 LOT NUMBER: 230709 COMPONENT TYPE: SCREW DESCRIPTION: INHANCE SHOULDER SYSTEM LOCKING SCREW 35MM. CATALOG NUMBER: 550310020 LOT NUMBER: 221055 COMPONENT TYPE: SCREW DESCRIPTION: INHANCE SHOULDER SYSTEM LOCKING SCREW 20MM. CATALOG NUMBER: 550536004 LOT NUMBER: 354620 COMPONENT TYPE: GLENOSPHERE DESCRIPTION: INHANCE SHOULDER SYSTEM GLENOSPHERE Ø36+4MM. CATALOG NUMBER: 550036100 LOT NUMBER: MI125077 COMPONENT TYPE: LINER DESCRIPTION: INHANCE SHOULDER SYSTEM REVERSE LINER RETENTIVE X-LINKED VITAMIN E PE Ø36+0MM. CATALOG NUMBER: 550300020 LOT NUMBER: 206618 COMPONENT TYPE: SCREW DESCRIPTION: INHANCE SHOULDER SYSTEM NON-LOCKING SCREW 20MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676861 STEMLESS M 36 SHOULDER IMPLANT - HUMERAL ANCHOR PKC DEPUY IRELAND - 3015516266 662988 10603295538257

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention