CORAIL L98413XRecalls & reported problems
Depuy (Ireland) · CORAIL HIP SYSTEM CORAIL REVISION BROACH, SIZE 13 · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295394204), received between Aug 27, 2018 and Dec 18, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Mechanical Jam1
Patient problems
- Insufficient Information1
- Limb Fracture1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 18, 2024Break; Break
ADDITIONAL INFORMATION RECEIVED: A. WAS THE OPERATION DELAYED DUE TO THE REPORTED EVENT? YES, 60 MINUTES. B. WAS THE PROCESS COMPLETED SUCCESSFULLY? YES. C. WERE FRAGMENTS CREATED? YES, THE RASP COULD NO LONGER BE REMOVED WITH THE STANDARD ATTACHMENT DUE TO THE BROKEN PIN. A FRACTURE OF THE GREATER TROCHANTER OCCURRED WHEN THE RASP WAS REMOVED. IF SO, WERE THEY EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION? A CERCLAGE OF THE GREATER TROCHANTER WAS PERFORMED. D. PATIENT STATUS/RESULT/CONSEQUENCES , IF ANOTHER MEDICAL INTERVENTION (E.G. X-RAY, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) WAS REQUIRED: TO DATE, NO FURTHER INTERVENTIONS HAVE BEEN NECESSARY. E. IS THE PATIENT PART OF A CLINICAL STUDY? NO.
Patient problems: Insufficient Information; Limb Fracture
MAUDE report 20964174 ↗MalfunctionAug 27, 2018Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE CALCAR MEDIUM DISC AND POST BOUND UP ON SIZE 13 CORAIL REVISION BROACH DURING SURGERY. ALL 3 PARTS ARE DAMAGED AND WILL NOT WORK SMOOTHLY TOGETHER. SURGICAL DELAY OF 1 MINUTE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7819281 ↗
Other BROACH devices
- NA 2598-07-550Depuy (Ireland) · BROACH323 reports
- SUMMIT 2570-00-000Depuy (Ireland) · BROACH269 reports
- NA 952212500FDepuy (Ireland) · BROACH245 reports
- ACTIS 2010-01-050Depuy (Ireland) · BROACH235 reports
- CORAIL 9522-11-500Depuy (Ireland) · BROACH210 reports
- ACTIS 2010-01-060Depuy (Ireland) · BROACH186 reports
- ACTIS 2010-01-040Depuy (Ireland) · BROACH172 reports
- ACTIS 2010-01-070Depuy (Ireland) · BROACH162 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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