BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP FEMORAL CONSTRUCT ACTIS

    MDR report key: 25142566 · Received May 11, 2026

    Report

    Report Number
    1818910-2026-08561
    Event Type
    Injury
    Date Received
    May 11, 2026
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LZO
    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 NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, (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: MAHON J, KEOGH C, MOHAMED B, BYRNE V, MORAN F, ROWAN F, SHERIDAN GA, CASHMAN JP. MULTICENTRE OUTCOMES OF TOTAL HIP ARTHROPLASTY USING A NOVEL COLLARED CEMENTLESS FEMORAL STEM. BONE JT OPEN. 2026 MAR 13;7(3):366-372. DOI: 10.1302/2633-1462.73.BJO-2025-0233.R1. PMID: 41819145; PMCID: PMC12981940. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS STUDY IS TO REPORT SHORT-TERM OUTCOMES AND SURVIVORSHIP FOR A NOVEL DESIGN OF FEMORAL COMPONENT ACROSS FOUR NON-DESIGNER CENTRES. BETWEEN JULY 2020 TO JANUARY 2025, A TOTAL OF 517 COMPONENTS IN 482 PATIENTS (221 WERE FEMALE (45.9%) AND MALE 261 (54.1) UNDERWENT PRIMARY THA (TOTAL HIP ARTHROPLASTY) USING ACTIS (DEPUY SYNTHES, USA) CEMENTLESS FEMORAL COMPONENT AND PINNACLE ACETABULAR SYSTEM (DEPUY SYNTHES, USA). THE MEAN PATIENT AGE WAS 60.9 YEARS (14 TO 94; SD 12.7). WITH PLANNED ROUTINE FOLLOW-UP AT SIX MONTHS AND TWO YEARS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: ACTIS (DEPUY SYNTHES, USA) CEMENTLESS FEMORAL COMPONENT AND PINNACLE ACETABULAR SYSTEM (DEPUY SYNTHES, USA) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL CONSTRUCT ACTIS (QTY 12). -N=1; UNDERWENT REVISION SURGERY FOR AN EARLY POPPF ON THE SECOND POSTOPERATIVE DAY. -N=1; OTHER REVISION CASE RETURNED TO THEATRE ONE MONTH POSTOPERATIVELY WITH A LARGE NON-RESOLVING HAEMATOMA DUE TO ANTICOAGULATION. -N=1; LIMB LENGTH DISCREPANCY OF < 2 CM WHICH WAS MANAGED WITH A SHOE RAISE. -N=4; EXPERIENCED WOUND ISSUES MANAGED BY THEIR PRIMARY CARE DOCTOR WITH ORAL ANTIBIOTICS, AND TWO PATIENTS REQUIRED TRANSFER OR ADMISSION TO HOSPITAL IN THE EARLY POSTOPERATIVE PERIOD FOR MEDICAL COMORBIDITIES. -N=2 PATIENTS AFFECTED BY PJI; ONE UNDERWENT DEBRIDEMENT WITH ANTIBIOTICS AND IMPLANT RETENTION TWO MONTHS POSTOPERATIVELY AND REMAINS ASYMPTOMATIC AND OFF ANTIBIOTICS AT 14 MONTHS FOLLOW-UP, THE OTHER PATIENT WAS MANAGED WITH ORAL ANTIBIOTICS AND PASSED AWAY DUE TO MALIGNANCY. -N=3 INSTABILITY - (N=2) MANAGED WITH CLOSED REDUCTION WITHOUT FURTHER SEQUELAE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR CONSTRUCT PINNACLE (QTY 9). -N=4; EXPERIENCED WOUND ISSUES MANAGED BY THEIR PRIMARY CARE DOCTOR WITH ORAL ANTIBIOTICS, AND TWO PATIENTS REQUIRED TRANSFER OR ADMISSION TO HOSPITAL IN THE EARLY POSTOPERATIVE PERIOD FOR MEDICAL COMORBIDITIES. -N=2 PATIENTS AFFECTED BY PJI; ONE UNDERWENT DEBRIDEMENT WITH ANTIBIOTICS AND IMPLANT RETENTION TWO MONTHS POSTOPERATIVELY AND REMAINS ASYMPTOMATIC AND OFF ANTIBIOTICS AT 14 MONTHS FOLLOW-UP, THE OTHER PATIENT WAS MANAGED WITH ORAL ANTIBIOTICS AND PASSED AWAY DUE TO MALIGNANCY. -N=3 INSTABILITY - (N=2) MANAGED WITH CLOSED REDUCTION WITHOUT FURTHER SEQUELAE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP FEMORAL HEAD AND UNKNOWN HIP ACETABULAR LINERS (QTY 2). -N=2 ISOLATED DISLOCATION - CLOSED REDUCTION WITHOUT FURTHER SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538952 UNK HIP FEMORAL CONSTRUCT ACTIS PROSTH, HIP, SEMI-CONSTR, METAL/CERAMIC/POLYM, CEMENT OR NON-POROUS, UNCEMENT LZO DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1