ACTIS 3010-01-005Recalls & reported problems
Depuy (Ireland) · ACTIS HIP SYSTEM BROACH SIZE 0 · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295548560), received between Mar 28, 2024 and Jun 30, 2025 — classified as 2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility2
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 30, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT DAMAGED ACTIS BROACH HARD TO ATTACH TO BROACH HANDLE POSSIBLE BURR OR BENT TRUNION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22366838 ↗MalfunctionMar 28, 2024Device-Device Incompatibility; Device-Device Incompatibility
THERE WAS NO SURGICAL DELAY OR IMPACT ON THE PATIENT IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18993165 ↗
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 3010-01-070Depuy (Ireland) · Instruments designed for press-fit osteochondral implants12 reports
- ACTIS 3010-01-040Depuy (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 3010-01-090Depuy (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 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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