BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIS

    MDR report key: 24828809 · Received April 9, 2026

    Report

    Report Number
    1818910-2026-06464
    Event Type
    Injury
    Date Received
    April 9, 2026
    Date of Event
    March 11, 2026
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    MEH
    UDI-DI
    10603295380610
    PMA / PMN Number
    K202472
    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.

    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: 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. ADDED: D10 CONCOMITANT.

    Description of Event or Problem · 0

    SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR PERIPROSTHETIC FRACTURE- FEMORAL-CALCAR DEVICE RELATED: NOT RELATED. PROCEDURE RELATED: CAUSAL RELATIONSHIP. DATE OF EVENT: (B)(6) 2026. DATE OF IMPLANT: (B)(6) 2026. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: OBSERVATION. DEPUY SYNTHES PRODUCTS USED. CATALOG NUMBER: 471056000. LOT NUMBER: 5021178. COMPONENT TYPE: SHELL. DESCRIPTION: EMPHASYS ACETABULAR SHELL NO-HOLE 56MM. CATALOG NUMBER: 472256036. LOT NUMBER: 5020334. COMPONENT TYPE: LINER. DESCRIPTION: EMPHASYS POLYETHYLENE LINER AOX NEUTRAL 56-58MM 36MM. CATALOG NUMBER: 101012090. LOT NUMBER: MA1444. COMPONENT TYPE: STEM. DESCRIPTION: ACTIS DUOFIX HIP PROSTHESIS (FEMORAL STEM 12/14 TAPER CEMENTLESS SIZE 9 HIGH COLLAR) CE. CATALOG NUMBER: 136536310. LOT NUMBER: 5030261. COMPONENT TYPE: HEAD. DESCRIPTION: BIOLOX DELTA CERAMIC FEMORAL HEAD +1.5 36MM DIA 12/14 TAPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251094 ACTIS HIP FEMORAL STEM MEH DEPUY ORTHOPAEDICS INC US MA1444 10603295380610

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention DELTA CER HEAD 12/14 36MM +1.5| EMSYS LNR AOX N 56-58X36| EMSYS SHL NOHOLE 56