ACTIS 101012060Recalls & reported problems
Depuy (Ireland) · ACTIS DUOFIX HIP PROSTHESIS (FEMORAL STEM 12/14 TAPER CEMENTLESS SIZE 6 HIGH COLLAR) CE · Class 2 · Implant
Quick summary
This DePuy ACTIS Duofix hip implant is a cementless femoral stem used in hip replacement surgery. Its 59 reports mostly describe pain and complications after surgery — infection around the implant, broken bones (including fractures after a fall), and the stem not growing properly into the bone or shifting. Fifty-three reports involved injuries and none involved deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 61
- Deaths reported
- 0
- Injuries reported
- 54
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10603295380580), received between Oct 20, 2017 and Sep 29, 2026 — classified as 54 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (8 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem33
- Loss of Osseointegration8
- Migration6
- Osseointegration Problem6
- Tear, Rip or Hole in Device Packaging4
- Device-Device Incompatibility3
- Device Contaminated During Manufacture or Shipping2
- Insufficient Device Problem Information2
Patient problems
- Unspecified Infection19
- Limb Fracture18
- Fall13
- Inadequate Osseointegration13
- No Code Available12
- No Clinical Signs, Symptoms or Conditions8
- Pain5
- Bone Fracture(s)3
Recent adverse event reports
The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that Patient was revised for periprosthetic fracture.DOI: Unknown.DOR: (b)(6) 2026. Affected Side: Unknown Hip.
Patient problems: Limb Fracture
MAUDE report 50933443 ↗MalfunctionSep 17, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812046 ↗InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that there was a periprosthetic fracture due to fall.Affected side: Unknown.
Patient problems: Fall; Limb Fracture
MAUDE report 50495034 ↗InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem
It was reported that ALTRX +4 10D 36IDX54OD was involved in a post-implant event concerning instability after a fall. During revision surgery, the insert was found to be no longer in its original position. The insert and femoral head were removed, new components were implanted, and implant stability was confirmed. The ALTRX +4 10D 36IDX54OD implant was explanted and is available for return. DELTA CER HEAD 12/14 36MM +1.5, PINN SECTOR W/GRIPTION 54MM, and ACTIS COLLARED HIGH SIZE 6 were also involved in the revision procedure and were explanted.
Patient problems: Fall; Joint Laxity
MAUDE report 50146613 ↗MalfunctionAug 3, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50117226 ↗InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE THREE WEEKS POST OP, THE PATIENT FELL OUT OF BED AND BROKE THE LEFT FEMUR THAT HAD JUST BEEN REPLACED. TOOK THE ACTIS STEM OUT, FIXED THE FRACTURE, AND PUT IN A RECLAIM MONOBLOC STEM. AFFECTED SIDE: LEFT HIP.
Patient problems: Fall; Limb Fracture
MAUDE report 25782576 ↗InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED AS THE IMPLANTS WERE REMOVED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. NO PATIENT CONSEQUENCE. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 24428527 ↗InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED: A. IS THE STEM A DEPUY PRODUCT? - YES. ACTIS. NOT REVISED.
Patient problems: Fall; Limb Fracture
MAUDE report 24214824 ↗InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
(B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK FOR Q4 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: "REVISION FOR INFECTION: THE ARTICULAR SURFACE OF THE FEMORAL HEAD SHOWS SEVERE METAL TRANSFER THE NON-ARTICULAR SURFACE OF THE POLY LINER SHOWS MINOR YELLOWING. THE ARTICULAR SURFACE SHOWS MODERATE YELLOWING AND EMBEDDED METAL".
Patient problems: Unspecified Infection
MAUDE report 23934549 ↗InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INFECTION OF STAGE 1 OF 2. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Unspecified Infection
MAUDE report 23077080 ↗InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT FELL DOWN THREE WEEKS FOLLOWING A TOTAL HIP ARTHROPLASTY, PERIPROSTHETIC FRACTURE OCCURRED. REMOVAL OF SIZE 6 ACTIS STEM, 36 +5 HEAD, PINNACLE 36 +4 NEURAL LINER. FOLLOWING REMOVAL RECLAIM MONOBLOC WAS PLACED. NO DELAY IN REMOVAL OF IMPLANTS. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.
Patient problems: Fall; Limb Fracture
MAUDE report 22770840 ↗MalfunctionJun 16, 2025Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE OUTER SHIPPING BOX WAS NOT DAMAGED. DAMAGE WAS TO PACKAGING OF IMPLANT, MAKING IMPLANT UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22213851 ↗InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. DOI: UNKNOWN DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT HIP.
Patient problems: Limb Fracture
MAUDE report 22118281 ↗InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT DEVELOPED A VERY BAD INFECTION. SURGEON REMOVED THE CONSTRUCT AND PUT IN AN ANTIBIOTIC SPACER. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 22106026 ↗InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
(B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 21983996 ↗InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT FEMUR WAS FRACTURED AND STEM WAS STILL INTACT. STEM WAS REMOVED AND REPLACED WITH A REVISION STEM/CABLES. THERE WAS NO DELAY REPORTED. AFFECTED SIDE: RIGHT HIP.
Patient problems: Limb Fracture
MAUDE report 21662798 ↗InjuryNov 12, 2024Migration; Migration
IT WAS REPORTED THAT THE PATIENT HAD FALLEN CAUSING A PROXIMAL FEMUR FRACTURE WHICH CAUSED THE STEM TO SUBSIDE AND DISLOCATE. THE STEM WAS REMOVED AND REPLACED WITH A ZIMMER REVISION STEM AND THE DOCTOR PLACED A +4 10 LINER TO HELP WITH STABILITY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Fall; Limb Fracture
MAUDE report 20664947 ↗InjuryOct 16, 2024Fracture; Fracture
PATIENT'S STEM WAS EXPLANTED DUE TO FRACTURE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Limb Fracture
MAUDE report 20462926 ↗InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION ONE STAGE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP SIDE.
Patient problems: Unspecified Infection
MAUDE report 20361871 ↗MalfunctionOct 2, 2024Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT ON (B)(6) 2024, THE SURGICAL TEAM WENT TO OPEN A 6 HIGH ACTIS STEM AND THE PACKAGING WAS NOT SEALED PROPERLY; PACKING WAS DAMAGED. YOU COULD SEE ON ONE SIDE WHERE IT WAS NOT PROPERLY "SEALED". THE DECISION WAS MADE BY OR TEAM THAT THIS IMPLANT SHOULD NOT BE USED ON THIS PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20352927 ↗MalfunctionJul 8, 2024Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT PACKAGE CAME WET AND OPEN. CONTENTS INSIDE WERE DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19688825 ↗InjuryApr 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS HAD PERSISTENT INFECTION. A SINGLE STAGE WASHOUT/REVISION WAS PREVIOUSLY PERFORMED BUT UNFORTUNATELY INFECTION WAS STILL PRESENT. SO ALL IMPLANTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 19080889 ↗MalfunctionJan 19, 2024Device-Device Incompatibility; Device-Device Incompatibility
SCRUB TECH REVIEWED THE BROACH, SAID 6HI, NURSE OPENED THE 6HI IMPLANT. UPON IMPLANTING REALIZED IT WAS TOO SMALL, WIPED THE BROACH AND REALIZED IT WAS A 8. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18542108 ↗InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INFECTION, EVERYTHING TAKEN OUT AND A PROSTALAC PUT IN. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Unspecified Infection
MAUDE report 18464135 ↗InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INFECTED HIP. SURGEON PULLED ALL IMPLANTS AND REPLACED WITH NEW. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2018, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT.
Patient problems: Unspecified Infection
MAUDE report 18440813 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.