ACTIS 101012050Recalls & reported problems
Depuy (Ireland) · ACTIS DUOFIX HIP PROSTHESIS (FEMORAL STEM 12/14 TAPER CEMENTLESS SIZE 5 HIGH COLLAR) CE · Class 2 · Implant
Quick summary
This DePuy Actis DuoFix hip implant is a cementless metal stem that replaces the top of the femur. Most of the 57 reports describe patients who later needed the stem removed or revised after falls that broke the bone around the implant, along with infections, pain, and the stem loosening or sinking. There were 49 injuries and no deaths. No recalls name this device, and reports rose from 3 in the earlier 12 months to 7 in the most recent.
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
- 57
- Deaths reported
- 0
- Injuries reported
- 49
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 10603295380573), received between Feb 2, 2018 and Aug 31, 2026 — classified as 49 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Migration” (5 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 Problem37
- Migration5
- Osseointegration Problem5
- Device-Device Incompatibility4
- Fitting Problem2
- Insufficient Device Problem Information2
- Loss of Osseointegration2
- Tear, Rip or Hole in Device Packaging2
Patient problems
- Unspecified Infection17
- Limb Fracture15
- No Code Available10
- Fall9
- Inadequate Osseointegration7
- Pain5
- Insufficient Information4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
Recent adverse event reports
The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.
InjuryAug 31, 2026Osseointegration Problem
Patient problems: Inadequate Osseointegration; Limb Fracture
MAUDE report 50522782 ↗InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FALL RESULTING IN A PERI-PROSTHETIC FEMUR FRACTURE, WHICH REQUIRED REMOVAL OF THE STEM AND PLACEMENT OF A RECLAIM. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.
Patient problems: Fall; Limb Fracture
MAUDE report 25693204 ↗InjuryMar 31, 2026Osseointegration Problem; Migration
IT WAS REPORTED THAT THE STEM SUBSIDED DUE TO FEMUR FRACTURE WHEN PATIENT FELL. IT WAS STATED THAT THE STEM WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. DOE: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.
Patient problems: Fall; Inadequate Osseointegration; Limb Fracture
MAUDE report 24747792 ↗InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO FALL WHICH CAUSED A PERI PROSTHETIC FRACTURE. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT.
Patient problems: Fall; Limb Fracture
MAUDE report 24698606 ↗InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT FELL IN THE BATHROOM AND FRACTURED THEIR FEMUR AROUND THE IMPLANT. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.
Patient problems: Fall; Limb Fracture
MAUDE report 23888441 ↗InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.
Patient problems: Pain
MAUDE report 23679842 ↗InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANTS WERE REMOVED DUE TO INFECTION. DOI- UNKNOWN. DOR- (B)(6) 2025. AFFECTED SIDE- LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 23622247 ↗InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANTS WERE REMOVED DUE TO INFECTION. STAGE 1 REVISION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 23357965 ↗InjuryJun 12, 2025Migration; Migration
IT WAS REPORTED THAT AFTER THEIR ORIGINAL SURGERY, THE STEM HAD SUBSIDED, AND THE PATIENT STARTED TO DISLOCATE WHICH IS WHY THE HIP WAS REVISED. THE SURGEON REMOVED THE ACTIS STEM AND WENT UP IN STEM SIZE, AFTER THE NEUTRAL LINER WAS REMOVED AND REPLACED WITH DUAL MOBILITY FOR STABILITY. AFFECTED AREA: UNK HIP.
Patient problems: Insufficient Information
MAUDE report 22194321 ↗InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD THEIR INITIAL SURGERY ON (B)(6) 2025. UNFORTUNATELY, THEIR HIP BECAME INFECTED. SURGEON WANTED TO PERFORM A SINGLE STAGE REVISION WHERE HE EXPLANTED THE COMPONENTS AND WENT BACK IN WITH NEW IMPLANTS. ONCE THE IMPLANTS WERE TAKEN OUT, IT WAS THOROUGHLY WASHED AND THE BONE WAS THEN PREPPED FOR NEW IMPLANTS. HIP WAS THEN REDUCED AND FOUND TO BE STABLE. CLOSING PROCESS BEGAN. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 21676806 ↗InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Pain
MAUDE report 20428489 ↗InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT HIP REVISION WAS DUE TO FEMORAL FRACTURE AS A RESULT OF THE PATIENT FALLING. STEM, HEADBALL AND LINER TO BE REVISED. DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- UNKNOWN HIP.
Patient problems: Fall; Limb Fracture
MAUDE report 20076004 ↗InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE STEM WAS REVISED FOR INSTABILITY. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2024; DOR: (B)(6) 2024; AFFECTED SIDE: UNKNOWN.
Patient problems: Joint Laxity
MAUDE report 20025971 ↗MalfunctionJul 16, 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 THE PRODUCT WAS DELIVERED WET, OPEN AND DAMAGED. UNKNOWN SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 19749508 ↗InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE INFECTED TOTAL HIP LINER, STEM, AND HIP BALL WERE EXPLANTED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 19214574 ↗InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2024 THE PATIENT WAS REVISED DUE TO DEHISCED WOUND THAT BECAME INFECTED. ALL PRODUCTS WERE REMOVED AND THE WOUND WAS WASHED AND NEW COMPONENTS WERE USED. NO DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection; Wound Dehiscence
MAUDE report 18970287 ↗MalfunctionMar 20, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT AFTER BROACHING WITH A 5 STEM WITH GREAT STABILITY THE SURGEON DECIDED THAT WAS THE CORRECT IMPLANT SIZE HE WANTED. IMPLANT WAS OPENED ONTO THE FIELD. WHEN IMPLANTING THE STEM INTO THE FEMUR THE IMPLANT DID NOT SEEM TO BE APPROPRIATE FOR THE SIZE IT SHOULD BE. IT WAS MUCH SMALLER THAN THE BROACH. ALL MEASURES WERE TAKEN TO CONFIRM THE CORRECT BROACH WAS USED AND THE CORRECT STEM WAS OPENED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE : UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 18947279 ↗InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO INFECTION. THE SURGEON PULLED ALL IMPLANTS AND PLACED ANTIBIOTIC SPACER. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Unspecified Infection
MAUDE report 18684246 ↗InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO. B. WAS THERE ANY ALLEGATION AGAINST THE HEAD? NONE.
Patient problems: Limb Fracture
MAUDE report 18571697 ↗InjuryJan 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF LEFT HIP DUE TO THIGH PAIN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.
Patient problems: Pain
MAUDE report 18551698 ↗MalfunctionJan 10, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SURGEON BELIEVES THAT THERE WAS AN ISSUE WITH THE STEM UPON IMPLANTING. THE STEM SAT PROUD RELATIVE TO WHERE THE BROACH SAT. THE STEM WAS NOT IMPLANTED AND IS BEING SENT IN FOR INSPECTION. UNKNOWN SURGICAL DELAY. DOE: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18482535 ↗InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE AFFECTED SITE WAS THE LEFT. THERE WERE NO ALLEGATION OR ACCUSATIONS OF ANY KIND.
Patient problems: Limb Fracture
MAUDE report 18283450 ↗InjuryNov 21, 2023Migration; Migration
IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH PARKINSONS. ACTIS STEM ROTATED SHORTLY AFTER ORIGINAL SURGERY. DOI: (B)(6) 2023. DOR: NOVEMBER 7, 2023. AFFECTED SIDE : RIGHT HIP.
Patient problems: Insufficient Information
MAUDE report 18182992 ↗InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO PROSTHETIC FRACTURE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.
Patient problems: Limb Fracture
MAUDE report 18011008 ↗InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED FOR FEMORAL FRACTURE POSTOPERATIVE. DOI: (B)(6) 2023 DOR: (B)(6) 2023 AFFECTED SIDE: LEFT SIDE .
Patient problems: Limb Fracture
MAUDE report 17843973 ↗
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.