BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK HIP FEMORAL STEM ACTIS

    MDR report key: 25136228 · Received May 11, 2026

    Report

    Report Number
    1818910-2026-08543
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    January 23, 2026
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: JAMIESON R, GUPTA A, RUPPENKAMP JW, PENG M, VARUGHESE B, DIAZ R. CAN DIFFERENT STEM DESIGN IMPACT HOSPITAL HEALTHCARE RESOURCE UTILIZATION FOLLOWING TOTAL HIP ARTHROPLASTY: A COMPARATIVE ANALYSIS USING US HOSPITAL BILLING DATABASE. CURR MED RES OPIN. 2025 DEC;41(12):2253-2261. DOI: 10.1080/03007995.2026.2619042. EPUB 2026 JAN 23. PMID: 41575175. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS STUDY WAS TO EVALUATE HEALTHCARE RESOURCE UTILIZATION AND OUTCOMES FROM A HOSPITAL PERSPECTIVE AMONG THA PATIENTS WHO RECEIVED TRIPLE TAPERED HIP STEM (TTS) COMPARED TO MORPHOMETRIC WEDGE (MMW) BASED FEMORAL STEM. A TOTAL OF 31,816 PATIENTS WHO UNDERWENT THA BETWEEN JANUARY 2016 - SEPTEMBER 2023 MET THE STUDY INCLUSION CRITERIA. 45% (N=14,238) OF IDENTIFIED PATIENTS WERE IMPLANTED WITH THE TTS DEVICE (ACTIS HIP SYSTEM) AND 55% (N=17,578) RECEIVED MMW (ACCOLADE II FEMORAL HIP SYSTEM). AT THE 90-DAY FOLLOW-UP, 13,412 TTS PATIENTS AND 16,564 MMW PATIENTS REMAINED IN THE COHORT, WITH 11,279 TTS PATIENTS AND 14,139 MMW PATIENTS INCLUDED AT THE 365-DAY FOLLOW-UP. PATIENTS IMPLANTED WITH THE TTS VS. MMW DEVICE SHOWED SIMILAR CHARACTERISTICS WITH A MEAN AGE OF 66.55 VS. 64.96 YEARS AND 43% VS. 47% MALE. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES ACTIS HIP SYSTEM. OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: ACETABULAR COMPONENT (UNKNOWN MANUFACTURER) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL CONSTRUCT ACTIS (QTY 1): INTRA-OPERATIVE FRACTURE: NO TREATMENT REPORTED, DEEP INFECTION; NO TREATMENT REPORTED, SUPERFICIAL INFECTION; NO TREATMENT REPORTED, PERIPROSTHETIC FRACTURE; NO TREATMENT REPORTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL STEM ACTIS (QTY 1): ASEPTIC LOOSENING; NO TREATMENT REPORTED, ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL HEAD (QTY 1): - DISLOCATION; NO TREATMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452381 UNK HIP FEMORAL STEM ACTIS FEMORAL STEM LPH DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1