ACTIS 3010-01-090Recalls & reported problems
Depuy (Ireland) · ACTIS HIP SYSTEM BROACH SIZE 9 · Class 2
All models of ACTIS (97)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295548683), received between Jun 12, 2023 and Mar 13, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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. 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
- Device-Device Incompatibility2
- Break1
- Illegible Information1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2026Break
IT WAS REPORTED THE BROACH IS UNABLE TO EXTRACT DUE TO A BROKEN TRUNNION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24591131 ↗MalfunctionMar 26, 2025Scratched Material; Illegible Information; Scratched Material; Illegible Information
IT WAS REPORTED THAT 9 MI ACTIS BROACH WAS SCRATCHED UP AND THE LABEL WAS DIFFICULT TO SEE. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21701860 ↗MalfunctionDec 8, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE BROACH WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18290450 ↗MalfunctionJun 12, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT NECK TRIALS WILL NOT FIT ON SIZE 9 BROACH. SURGICAL DELAY UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17108775 ↗
Other Instruments designed for press-fit osteochondral implants devices
- ACTIS 3010-01-060Depuy (Ireland) · Instruments designed for press-fit osteochondral implants14 reports
- ACTIS 3010-01-050Depuy (Ireland) · Instruments designed for press-fit osteochondral implants14 reports
- ACTIS 3010-01-040Depuy (Ireland) · Instruments designed for press-fit osteochondral implants12 reports
- ACTIS 3010-01-070Depuy (Ireland) · Instruments designed for press-fit osteochondral implants12 reports
- ACTIS 3010-01-080Depuy (Ireland) · Instruments designed for press-fit osteochondral implants7 reports
- ACTIS 3010-01-010Depuy (Ireland) · Instruments designed for press-fit osteochondral implants5 reports
- ACTIS 3010-01-020Depuy (Ireland) · Instruments designed for press-fit osteochondral implants4 reports
- ACTIS 3010-01-030Depuy (Ireland) · Instruments designed for press-fit osteochondral implants4 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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