ACTIS 1010-21-070Recalls & reported problems
Depuy (Ireland) · ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS STANDARD COLLARLESS SIZE 7 · Class 2 · Implant
All models of ACTIS (97)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295526667), received between Oct 2, 2024 and Feb 5, 2026 — classified as 5 injuries.
The most frequently reported specific device problem is “Migration” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Migration3
- Adverse Event Without Identified Device or Use Problem2
- Osseointegration Problem1
Patient problems
- Fall2
- Unspecified Infection2
- Inadequate Osseointegration1
- Insufficient Information1
- Limb Fracture1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryFeb 5, 2026Migration
IT WAS REPORTED THAT THE STEM AND HEADBALL REMOVAL DUE TO PATIENT FALL AND PROSTHESIS MIGRATION.
Patient problems: Fall
MAUDE report 24270410 ↗InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PATIENT WAS INFECTED SO IMPLANTS WERE REMOVED AND ANTIBIOTIC SPACER WAS PUT IN. ORIGINAL IMPLANT DATE: (B)(6) 2025. EXPLANT DATE: (B)(6) 2025.
Patient problems: Unspecified Infection
MAUDE report 23647070 ↗InjuryJun 11, 2025Migration; Migration
IT WAS REPORTED THAT THE PATIENT'S 7 STD ACTIS STEM WAS SUBSIDED. THE STEM AND HEAD WERE REMOVED AND REPLACED WITH A RECLAIM MONOBLOC STEM AND 32 +1 CERAMIC HEAD. THERE WAS NO DELAY IN CASE. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Insufficient Information
MAUDE report 22187050 ↗InjuryMay 14, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration
IT WAS REPORTED THAT THE PATIENT WITH A DEPUY TOTAL HIP REPLACEMENT FELL AND FRACTURED HER FEMUR, CAUSING THE STEM TO LOOSEN AND SUBSIDE. THERE WAS LOOSENING OF THE FEMORAL STEM BECAUSE OF FRACTURE. FEMORAL STEM AND FEMORAL HEAD WERE REMOVED AND REPLACED. THE FRACTURE WAS FIXED WITH CABLES, THEN A NEW STEM AND HEAD WERE IMPLANTED. AFFECTED SIDE: RIGHT HIP.
Patient problems: Fall; Inadequate Osseointegration; Limb Fracture
MAUDE report 22019209 ↗InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT : THERE WAS NO SURGICAL DELAY.
Patient problems: Unspecified Infection
MAUDE report 20350441 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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