ACTIS 3010-01-010Recalls & reported problems
Depuy (Ireland) · ACTIS HIP SYSTEM BROACH SIZE 1 · Class 2
All models of ACTIS (97)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295548577), received between Jun 8, 2023 and Dec 9, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
- Break5
- No Apparent Adverse Event3
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2025Break; Break
IT WAS REPORTED THAT BROACH WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23758462 ↗MalfunctionOct 28, 2024Break; Break
IT WAS REPORTED THAT THE BROACH TIP FELL OFF.
Patient problems: Insufficient Information
MAUDE report 20543402 ↗MalfunctionJun 8, 2023Break; No Apparent Adverse Event; Break; No Apparent Adverse Event
IT WAS REPORTED THAT THE BROACH BROKE AFTER THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17089634 ↗MalfunctionJun 8, 2023Break; No Apparent Adverse Event; Break; No Apparent Adverse Event
IT WAS REPORTED THAT THE BROACH BROKE AFTER THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17089618 ↗MalfunctionJun 8, 2023Break; No Apparent Adverse Event; Break; No Apparent Adverse Event
IT WAS REPORTED THAT THE BROACH BROKE AFTER THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17089609 ↗
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 3010-01-020Depuy (Ireland) · Instruments designed for press-fit osteochondral implants4 reports
- ACTIS 3010-01-030Depuy (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 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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