ACTIS 101011060Recalls & reported problems
Depuy (Ireland) · ACTIS DUOFIX HIP PROSTHESIS (FEMORAL STEM 12/14 TAPER CEMENTLESS SIZE 6 STD COLLAR) CE · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ACTIS DUOFIX hip prosthesis is a metal femoral stem used in hip replacement surgery. The 64 reports mostly describe the stem loosening or sinking into the bone, infection around the implant, and bone fractures after falls, along with a few packaging seal failures. Reports mention no deaths and 55 injuries. 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
- 66
- Deaths reported
- 0
- Injuries reported
- 57
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 10603295380467), received between Nov 19, 2019 and Sep 23, 2026 — classified as 57 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Osseointegration Problem” (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 Problem45
- Osseointegration Problem8
- Migration6
- Tear, Rip or Hole in Device Packaging5
- No Apparent Adverse Event3
- Device Contaminated During Manufacture or Shipping2
- Loss of Osseointegration2
- Device Damaged Prior to Use1
Patient problems
- Unspecified Infection23
- Limb Fracture13
- Inadequate Osseointegration10
- Fall9
- No Code Available9
- No Clinical Signs, Symptoms or Conditions7
- Pain6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
Recent adverse event reports
The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fall; Limb Fracture
MAUDE report 50873606 ↗InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient was revised due to prostalac placement for infection. There was a removal of all implants.DOI: (b)(6) 2024.DOR: (b)(6) 2026.Affected side: Left.
Patient problems: Unspecified Infection
MAUDE report 50530852 ↗InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem
It was reported that Stem and head were replaced due to a fracture. There was no harm done to the patient. And implants were removed from the field and disposed of immediately.DOI: Unknown.DOR: (b)(6) 2026.Affected side: Right.
Patient problems: Limb Fracture
MAUDE report 50103709 ↗InjuryJul 29, 2026Osseointegration Problem
It was reported that Patient fell while going down the steps and fx their femur.Affected side-Left hip.
Patient problems: Fall; Inadequate Osseointegration; Limb Fracture
MAUDE report 50072832 ↗InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT HIP.
Patient problems: Pain
MAUDE report 24998982 ↗InjuryApr 21, 2026Osseointegration Problem; Migration
IT WAS REPORTED THAT STEM SUBSIDENCE. IT WAS STATED THAT FEMORAL STEM1365 WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS BONE TO IMPLANT.
Patient problems: Inadequate Osseointegration
MAUDE report 24936194 ↗MalfunctionApr 13, 2026Tear, Rip or Hole in Device Packaging; No Apparent Adverse Event
IT WAS REPORTED THAT THE ITEMS CAME IN A NEW BOX WITH A BAG. ITEM APPEARED TO BE DAMAGED IN SHIPPING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24859133 ↗MalfunctionApr 13, 2026Tear, Rip or Hole in Device Packaging; No Apparent Adverse Event
IT WAS REPORTED THAT THE STEM PACKAGING HAD A MANUFACTURING ERROR. THE SEALS WERE NOT AIR TIGHT. THE SECOND BARRIER PROTRUDED THROUGH THE FIRST BARRIER WHEN IT WAS SEALED. THIS IS THE SECOND 6STD STEM IN THE PAST 2 MONTHS THAT THIS HAS HAPPENED. AFFECTED SIDE- UNKNOWN HIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24857988 ↗MalfunctionMar 17, 2026Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE SECOND BARRIER OF THE STEM WAS PROTRUDING THROUGH THE FIRST BARRIER SEAL THUS CAUSING IT TO LOSE THE AIRTIGHT SEAL. THE SECOND BARRIER WAS ALSO COMPROMISED AND NOT AIR SEALED. THE BOX WAS SEALED AND NOT TAMPERED WITH. THIS WAS A PRODUCTION ERROR THAT OCCURRED DURING THE SEALING PROCESS. AFFECTED SIDE: UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24617915 ↗InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION, EXPLANTED ALL COMPONENTS FOR I AND D. THERE WAS NO DELAY IN THE CASE, THERE WAS NO HARM DONE TO THE PATIENT, THERE WERE NO COMPLAINTS. I HAD NO FURTHER INFORMATION LAST REVISION WAS (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 24531197 ↗MalfunctionMar 4, 2026Difficult to Open or Remove Packaging Material
IT WAS REPORTED THAT WHILE THE NURSE WAS OPENING THE STERILE IMPLANT THE IMPLANT GOT STUCK TO THE STERILE WRAPPER AND WAS CONTAMINATED. ANOTHER IMPLANT WAS OPENED SUCCESSFULLY TO COMPLETE CASE. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24507974 ↗InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO FALL SEVERAL DAYS AFTER SURGERY AND HAD A PROXIMAL FEMUR FRACTURE. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.
Patient problems: Fall; Limb Fracture
MAUDE report 24499826 ↗InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ARTIFICIAL BONE REPLACEMENT SURGERY ON HIP JOINT WITH THE PRODUCTS IN QUESTION. AFTER THE SURGERY, THE INFECTION WAS SUSPECTED. THE DEBRIDEMENT WAS PERFORMED ON (B)(6) 2026, BUT THE INFECTION NUMBERS DID NOT IMPROVE. NO FURTHER INFORMATION IS AVAILABLE. THIS PC IS RELATED TO (B)(4) WHICH REPORTS THE REMOVAL SURGERY. THIS PC REPORTS THE DEBRIDEMENT PERFORMED ON (B)(6) 2026.
Patient problems: Unspecified Infection
MAUDE report 24236003 ↗InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT HIP.
Patient problems: Pain
MAUDE report 24212114 ↗InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
IT WAS REPORTED THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2025. AFTER THE SURGERY, THE INFECTION WAS SUSPECTED. THE DEBRIDEMENT WAS PERFORMED ON (B)(6) 2026, (REPORTED ON (B)(4)) BUT THE INFECTION NUMBERS DID NOT IMPROVE. THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2026, DURING THE SURGERY, THE STEM WAS FIXED AND ONLY THE ACETABULAR SIDE WAS REMOVED. THE CEMENT MOLD WAS PLACED AND THE SURGERY WAS COMPLETED.
Patient problems: Unspecified Infection
MAUDE report 24211458 ↗InjuryDec 11, 2025Improper or Incorrect Procedure or Method; Noise, Audible; Improper or Incorrect Procedure or Method; Noise, Audible
PATIENT WAS REPORTING "CLANKING" DURING POST OP PT. X-RAYS LOOKED IN ORDER ACCORDING TO THE SURGEON, SO THEIR ASSUMPTION WAS THAT THE LINER MAY HAVE NOT ENGAGED FULLY. PATIENT WAS TAKEN BACK TO SURGERY; STEM AND FEMORAL HEAD WERE EXPLANTED. THE CUP AND LINER WERE SOLID WITH NO VISIBLE ISSUE ACCORDING TO THE SURGEON. THE SURGEON DETERMINED THE STEM TO BE UNDERSIZED AND LOOSE AT NON-CEMENTED INTERFACE. FEMUR WAS REBROACHED UP TO A SIZE 7 ACTIS COLLARED; HAD GOOD AXIAL AND ROTATIONAL STABILITY. A +12MM TS HEAD WAS IMPACTED AND THE LEG WAS REDUCED. CONSTRUCT WAS STABLE, HAD GOOD SCHUCK, AND WAS NOT DISLOCATING/IMPINGING. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23778904 ↗InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD HIS HIP REPLACED ON (B)(6) 2025 BY SURGEON. HE CAME INTO THE ER FEELING SICK, A FEVER, AND HIP PAIN. AFTER EXAMINATION, IT WAS DETERMINED THAT HIS LEFT HIP WAS INFECTED. SURGEON DECIDED TO DO A REVISION SURGERY WHERE ALL THE IMPLANTS WERE EXPLANTED, A THOROUGH DEBRIDEMENT WAS DONE, AND THEN NEW COMPONENTS WERE IMPLANTED. ACTIVITY LEVEL: YES, DOI: ON (B)(6) 2025, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT HIP.
Patient problems: Pain; Unspecified Infection
MAUDE report 23328059 ↗InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT TRIPPED AND FELL SIX HOURS POST OPERATIVELY CAUSING A PERIPROSTHETIC FEMUR FRACTURE. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT SIDE.
Patient problems: Fall; Limb Fracture
MAUDE report 22678096 ↗InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTED HIP. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 22087526 ↗InjuryMay 22, 2025Adverse 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. AFFECTED SIDE: RIGHT HIP.
Patient problems: Pain
MAUDE report 22069589 ↗InjuryMay 2, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration
IT WAS REPORTED THAT THE PATIENT TRIPPED AND FELL CAUSING LESSER TROCHANTER TO BREAK AND STEM TO SUBSIDE. ACTIS FEMORAL STEM WAS LOOSE. LOOSENING INTERFACE WAS NON-CEMENTED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.
Patient problems: Fall; Inadequate Osseointegration; Limb Fracture
MAUDE report 21952222 ↗InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO UNSTABLE IMPLANT. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.
Patient problems: Joint Laxity
MAUDE report 21142593 ↗InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO.
Patient problems: Unspecified Infection
MAUDE report 20735814 ↗InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO PERI-PROSTHETIC FRACTURE. PATIENT FELL. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Fall; Limb Fracture
MAUDE report 20248722 ↗InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD INFECTION IN THE HIP. REMOVED TOTAL HIP AND REPLACED WITH ANTIBIOTIC SPACER. DOI: (B)(6) 2023; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 19352477 ↗
Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices
- STAGEONE 431209Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 recalls0 reports
- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- Compress® Device 178552Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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