ACTIS 1010-21-060Recalls & reported problems
Depuy (Ireland) · ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS STANDARD COLLARLESS SIZE 6 · Class 2 · Implant
All models of ACTIS (97)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295526650), received between Jan 31, 2023 and Nov 18, 2025 — classified as 7 injuries.
The most frequently reported specific device problem is “Migration” (1 report).
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 Problem5
- Migration1
- Osseointegration Problem1
Patient problems
- Limb Fracture6
- Fall1
- Inadequate Osseointegration1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT FELL AND FRACTURED CALCAR. SURGEON WENT IN WITH LONGER STEM. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.
Patient problems: Limb Fracture; Pain
MAUDE report 23583410 ↗InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED WITH REMOVAL OF STEM AND HEAD DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Unspecified Infection
MAUDE report 20700059 ↗InjurySep 9, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT PATIENT SUSTAINED A FALL AFTER TOTAL HIP ARTHROPLASTY WHICH RESULTED IN A PERIPOROSTHETIC PROXIMAL FEMUR FRACTURE. AS A RESULT, A REVISION TOTAL HIP ARTHROPLASTY WAS PERFORMED TO ADDRESS THE FRACTURE AND LOOSE STEM. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Inadequate Osseointegration; Limb Fracture
MAUDE report 20168889 ↗InjurySep 5, 2024Migration; Migration
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO FALL AFTER PRIMARY TOTAL HIP ARTHROPLASTY, RESULTING IN A PERIPROSTHETIC PROXIMAL FEMUR FRACTURE WITH SUBSIDENCE OF THE STEM. SURGEON ELECTED FOR REVISION TOTAL HIP ARTHROPLASTY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Fall; Limb Fracture
MAUDE report 20148516 ↗InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF ACTIS TO RECLAIM. ADDITIONAL EVENT INFORMATION: ON 29-SEPT-2023, SALES REP STATED THAT THE REVISION WAS DUE TO A FEMUR FRACTURE.
Patient problems: Limb Fracture
MAUDE report 17845336 ↗InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF ACTIS TO RECLAIM DUE TO FRACTURE.
Patient problems: Limb Fracture
MAUDE report 17844896 ↗InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CALCAR FRACTURE WHEN IMPLANTING AN ACTIS COLLARLESS STEM.
Patient problems: Limb Fracture
MAUDE report 16271895 ↗
Other Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate devices
- Novation 130-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls156 reports
- Novation 130-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls79 reports
- CORAIL 3L92511Depuy (Ireland) · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate158 reports
- Acumatch A Series 138-36-29Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 recalls1 report
- Novation 136-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls43 reports
- Novation 130-32-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls33 reports
- Novation 132-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls26 reports
- Novation 136-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls22 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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