ACTIS 101011110Recalls & reported problems
Depuy (Ireland) · ACTIS DUOFIX HIP PROSTHESIS (FEMORAL STEM 12/14 TAPER CEMENTLESS SIZE 11 STD COLLAR) CE · Class 2 · Implant
All models of ACTIS (97)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295380511), received between Jan 12, 2023 and Jan 15, 2026 — classified as 2 injuries.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Fall1
- Limb Fracture1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INFECTED TOTAL HIP. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 24079567 ↗InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO TRAUMATIC FALL RESULTING IN FRACTURED FEMUR. SURGEON EXPLANTED STEM, HEAD AND LINER TO ACCOMMODATE COMPETITIVE REVISION STEM AND MDM CONSTRUCT. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.
Patient problems: Fall; Limb Fracture
MAUDE report 16146790 ↗
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
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 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
- 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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