BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL CONSTRUCT ACTIS

    MDR report key: 24118004 · Received January 20, 2026

    Report

    Report Number
    1818910-2026-01148
    Event Type
    Injury
    Date Received
    January 20, 2026
    Date of Event
    October 16, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    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: D2A: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED. 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 DEVICE LOT NUMBER IS UNKNOWN; THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: LEBRUN DG, RUIZ V, GAUSDEN EB, WESTRICH GH. TRIPLE-TAPER COLLARED STEM MORPHOLOGY INFLUENCES PERIPROSTHETIC FEMORAL FRACTURE RISK: A COMPARISON OF SINGLE-, DUAL-, TRIPLE-, AND QUADRANGULAR-TAPER STEMS. J ARTHROPLASTY. 2025 OCT 23:S0883-5403(25)01324-5. DOI: 10.1016/J.ARTH.2025.10.045. EPUB AHEAD OF PRINT. PMID: 41138996. OBJECTIVE/METHODS/STUDY DATA: THIS STUDY AIMS TO COMPARE TRIPLE-TAPER COLLARED STEMS WITH SINGLE, DUAL, AND QUADRANGULAR-TAPER STEMS IN TERMS OF (1) OVERALL PFF FRACTURE RISK, (2) INTRAOPERATIVE PFF RISK, AND (3) EARLY (90-DAY) POSTOPERATIVE PFF RISK, USING UNIVARIATE AND MULTIVARIABLE ANALYSES. BETWEEN FEBRUARY 2016 TO DECEMBER 2023 , A TOTAL OF (N = 23,448) PRIMARY TOTAL HIP ARTHROPLASTY (THA) CASES FROM USING CEMENTLESS SINGLE-TAPER (N = 8,529) WHICH INCLUDES N = 2,757 TRI-LOCK (DEPUY SYNTHES), DUAL-TAPER (N = 8,514) WHICH INCLUDES N = 2,080 SUMMIT (DEPUY SYNTHES), TRIPLE-TAPER COLLARED (N = 4,024) WHICH INCLUDES N = 2,810 ACTIS (DEPUY SYNTHES), AND QUADRANGULAR-TAPER STEMS (N = 2,381) WHICH INCLUDES N = 865 CORAIL (DEPUY SYNTHES), WERE EVALUATED. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: TRI-LOCK, SUMMIT, ACTIS, CORAIL. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL CONSTRUCT ACTIS (QTY 10): N=6 INTRAOPERATIVE PERIPROSTHETIC FEMORAL FRACTURE ¿ NO TREATMENT REPORTED. N=4 POSTOPERATIVE PERIPROSTHETIC FEMORAL FRACTURE ¿ NO TREATMENT REPORTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL CONSTRUCT CORAIL (QTY 17): N=13 INTRAOPERATIVE PERIPROSTHETIC FEMORAL FRACTURE ¿ NO TREATMENT REPORTED. N=4 POSTOPERATIVE PERIPROSTHETIC FEMORAL FRACTURE ¿ NO TREATMENT REPORTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL CONSTRUCT SUMMIT (QTY 19): N=12 INTRAOPERATIVE PERIPROSTHETIC FEMORAL FRACTURE ¿ NO TREATMENT REPORTED. N=7 POSTOPERATIVE PERIPROSTHETIC FEMORAL FRACTURE ¿ NO TREATMENT REPORTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL CONSTRUCT TRI-LOCK (QTY 16): N=9 INTRAOPERATIVE PERIPROSTHETIC FEMORAL FRACTURE ¿ NO TREATMENT REPORTED. N=7 POSTOPERATIVE PERIPROSTHETIC FEMORAL FRACTURE ¿ NO TREATMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177986 UNKNOWN HIP FEMORAL CONSTRUCT ACTIS PROSTHESIS, HIP, SEMI-CONSTRAINED LZO DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention