BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW 35

    MDR report key: 24313190 · Received February 11, 2026

    Report

    Report Number
    1818910-2026-02804
    Event Type
    Malfunction
    Date Received
    February 11, 2026
    Date of Event
    January 26, 2026
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    HSD
    UDI-DI
    10603295546603
    PMA / PMN Number
    K212737
    Product Problem
    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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: 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. DEVICE HISTORY LOT: THERE IS 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.

    Description of Event or Problem · 0

    SUBJECT ID: (B)(6) STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR IMPLANT SHIFT DEVICE RELATED: CASUAL RELATIONSHIP (HUMERAL STEMLESS IMPLANT: YES) PROCEDURE RELATED: POSSIBLE DATE OF EVENT: 26 JAN 2026 DATE OF IMPLANT: (B)(6) 2025 DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: OBSERVATION. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 550011240 LOT NUMBER: 66451 COMPONENT TYPE: BASEPLATE DESCRIPTION: INHANCE SHOULDER SYSTEM MODULAR UNITI PLATFORM BASEPLATE SMALL Ø24MM CEMENTLESS. CATALOG NUMBER: 550035600 LOT NUMBER: 237381 COMPONENT TYPE: SCREW DESCRIPTION: INHANCE SHOULDER SYSTEM CENTRAL SCREW Ø6.0 X 35MM. CATALOG NUMBER: 550310035 LOT NUMBER: 229426 COMPONENT TYPE: SCREW DESCRIPTION: INHANCE SHOULDER SYSTEM LOCKING SCREW 35MM. CATALOG NUMBER: 550310025 LOT NUMBER: 233600 COMPONENT TYPE: SCREW DESCRIPTION: INHANCE SHOULDER SYSTEM LOCKING SCREW 25MM. CATALOG NUMBER: 550310035 LOT NUMBER: 223956 COMPONENT TYPE: SCREW DESCRIPTION: INHANCE SHOULDER SYSTEM LOCKING SCREW 35MM. CATALOG NUMBER: 550540008 LOT NUMBER: 333136 COMPONENT TYPE: GLENOSPHERE DESCRIPTION: INHANCE SHOULDER SYSTEM GLENOSPHERE Ø40+8MM. CATALOG NUMBER: 520000044 LOT NUMBER: 659883 COMPONENT TYPE: HUMERAL DESCRIPTION: INHANCE SHOULDER SYSTEM STEMLESS X-LARGE DIAMETER 44MM CEMENTLESS. CATALOG NUMBER: 550000440 LOT NUMBER: 659083 COMPONENT TYPE: SHELL DESCRIPTION: INHANCE SHOULDER SYSTEM REVERSE HUMERAL SHELL X-LARGE Ø44+0MM. CATALOG NUMBER: 550040104 LOT NUMBER: MI124741 COMPONENT TYPE: LINER DESCRIPTION: INHANCE SHOULDER SYSTEM REVERSE LINER RETENTIVE X-LINKED VITAMIN E PE Ø40+4MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378194 LOCKING SCREW 35 SHOULDER IMPLANT - LOCKING SCREW HSD DEPUY IRELAND - 3015516266 223956 10603295546603

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male CENTRAL SCREW 6.0X35| GLENOSPHERE 40+8| LOCKING SCREW 25| LOCKING SCREW 35| MOD UNITI CONV BASEPLATE S 24| REVERSE HUMERAL SHELL XL 44+0| REVERSE LINER 40+4 R| STEMLESS XL 44