ACTIS 1010-21-050Recalls & reported problems
Depuy (Ireland) · ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS STANDARD COLLARLESS SIZE 5 · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295526643), received between Oct 6, 2023 and Jul 27, 2026 — classified as 4 injuries.
The most frequently reported specific device problem is “Migration” (2 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 Problem2
- Migration2
- Osseointegration Problem1
Patient problems
- Limb Fracture4
- Fall1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
It was reported that Stem revision for periprosthetic fracture due to fall.Affected Side: Right Hip.
Patient problems: Fall; Limb Fracture
MAUDE report 50009384 ↗InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. ACETABULAR CUP REMAINED IN PATIENT. DOI: ON (B)(6) 2023, DOR: ON (B)(6) 2024, AFFECTED SIDE : RIGHT HIP.
Patient problems: Limb Fracture
MAUDE report 18490218 ↗InjuryOct 6, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration
THE PATIENT WAS REVISED DUE TO THE FRACTURE OF THE FEMUR. THERE WAS A SUBSIDENCE OF THE STEM. THERE WAS LOOSENING OF THE STEM AT THE NON CEMENTED INTERFACE. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: UNKNOWN.
Patient problems: Limb Fracture
MAUDE report 17886178 ↗InjuryOct 6, 2023Migration; Migration
PATIENT WAS REVISED DUE TO FEMUR FRACTURE/ STEM SUBSIDENCE. DOI: (B)(6) 2023 . DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.
Patient problems: Limb Fracture
MAUDE report 17885978 ↗
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 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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