CORAIL L98111Recalls & reported problems
Depuy (Ireland) · CORAIL HIP SYSTEM CEMENTLESS FEMORAL STEM HA COATED REVISION 12/14 AMT 135 DEGREES HIGH OFFSET COLLAR SIZE 11 · Class 2 · Implant
All models of CORAIL (121)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295262398), received between Oct 29, 2018 and Jul 1, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (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. 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
- Loss of Osseointegration1
- Use of Device Problem1
Patient problems
- Ambulation or Postural Difficulties1
- Bone Fracture(s)1
- Inadequate Osseointegration1
- No Code Available1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 1, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A STEM PH REVIS TIGE CIM CORAIL HO T11 185 MM. ON AN UNKNOWN DATE IN 2023 DRIVING IN OF THE STEM WITH RUPTURE OF THE DISTAL 1/3. NO FUNCTIONAL RESENTMENT. THE PATIENT DID NOT WISH TO HAVE SURGERY BECAUSE THERE WAS NO GENE. NO SENSATION WAS NOTED. IN 2025, THE PATIENT RETURNED FOR A CHECK-UP REGARDING THE LEFT HIP PROSTHESIS. PATIENT WAS IN A SIGNIFICANT PAIN, DIFFICULTY WALKING, WITH A TILT OF THE STEM OBSERVED DUE TO A KAR FRACTURE ON THE X-RAY. PATIENT WAS REVISED WITH HIP PROSTHESIS -CHANGE OF FEMORAL ROD (LEFT)/GENERAL ANESTHESIA. AFFECTED SIDE: LEFT.
Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Pain
MAUDE report 22375330 ↗InjuryOct 29, 2018Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT THE PATIENT HAD A FALL THAT RESULTED TO A FRACTURE BELOW HIS LESSER TROCHANTER, CAUSING THE STEM TO LOOSEN AT THE BONE TO IMPLANT INTERFACE.
Patient problems: Inadequate Osseointegration; No Code Available
MAUDE report 8013553 ↗
Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate devices
- Novation 130-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls156 reports
- Novation 130-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls79 reports
- CORAIL 3L92511Depuy (Ireland) · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate158 reports
- Acumatch A Series 138-36-29Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 recalls1 report
- Novation 136-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls43 reports
- Novation 130-32-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls33 reports
- Novation 132-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls26 reports
- Novation 136-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls22 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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