ACTIS 1010-22-080Recalls & reported problems
Depuy (Ireland) · ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS HIGH COLLARLESS SIZE 8 · Class 2 · Implant
All models of ACTIS (97)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295526803), received between Sep 28, 2023 and Jan 6, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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 Problem2
- Device-Device Incompatibility1
Patient problems
- Fall1
- Limb Fracture1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
- Unspecified Infection1
- Wound Dehiscence1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT IS ON DIALYSIS, FELL AND BROKE HER HIP IN JUNE. A TOTAL HIP WAS DONE THEN; SHE HAD A LINER AND HEAD REVISION ON (B)(6) 2025 BECAUSE SHE DISLOCATED MULTIPLE TIMES. SOMEWHERE BETWEEN ON (B)(6) 2025 AND TODAY SHE DISLOCATED AGAIN. SHE WAS NOT AT THE HOSPITAL FOR HIP PAIN BUT THEY TOOK AND X RAY ANYWAY AND FOUND IT TO BE DISLOCATED. PATIENT ALSO HAD WHAT WAS BELIEVED TO BE A SINUS TRACK ON HER SCAR SO THE DOCTOR DECIDED TO DO AN EXPLANT WITH GIRDLE STONE. AFFECTED SIDE: RIGHT HIP.
Patient problems: Pain; Unspecified Infection; Wound Dehiscence
MAUDE report 23974300 ↗MalfunctionMar 8, 2024Device-Device Incompatibility; Device-Device Incompatibility
SURGEON USING ACTIS STEM, FIRST CASE, TEMPLATED SIZE 6, ENDED UP BROACHING UP TO 8. SATISFIED WITH 8, IMPLANT STEM 8, HOWEVER IT SUNK 1 CM DEEP. ENDED USING A 9, AND IT SUNK AS WELL. FINALLY USED A SIZE 10, AND WAS SATISFIED WITH FINAL FIT. PERHAPS TEMPLATING WAS INCORRECT BASED ON MAGNIFICATION. PERHAPS FINAL BROACH SIZE WAS UNDERSIZED. A 5 MINUTE SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18864903 ↗InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT STEM AND HEAD WERE REPLACED WITH A REVISION STEM DUE TO A PERIPROSTHETIC FEMUR FRACTURE FROM A FALL. NOTHING MORE TO REPORT. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT HIP.
Patient problems: Fall; Limb Fracture
MAUDE report 17836051 ↗
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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