CORAIL L981210Recalls & reported problems
Depuy (Ireland) · CORAIL HIP SYSTEM CEMENTLESS FEMORAL STEM HA COATED 12/14 AMT 125 DEGREES STANDARD NO COLLAR SIZE 10 · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295452539), received between Mar 26, 2021 and Jul 16, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Degraded” (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
- Degraded1
- Loss of Osseointegration1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- Ambulation or Postural Difficulties1
- Cyst(s)1
- Discomfort1
- Extraskeletal ossification1
- Foreign Body Reaction1
- Inadequate Osseointegration1
- Insufficient Information1
- Loss of Range of Motion1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE CUSTOMER RECEIVED WET IMPLANTS. MULTIPLE PRODUCTS ARE DAMAGED. THE CASE WAS PUSHED TO TODAY FROM LAST THURSDAY.
Patient problems: Insufficient Information
MAUDE report 19750126 ↗InjuryMar 26, 2021Degraded; Loss of Osseointegration; Degraded; Loss of Osseointegration
IT WAS REPORTED THAT THE PATIENT HAD GENERAL PAIN AND THIGH PAIN - MOM / CORAIL HIP - METAL INSERT EXCHANGED FOR A POLY INSERT - STEM REVISED TO A BIOMET REVISION STEM - CORROSION ON TAPER OF CORAIL STEM - SOME OSTEOLYSIS BEHIND THE RETAINED CUP WAS FILLED WITH BONE GRAFT. NO SURGICAL DELAY. DOI: 2011, DOR: (B)(6) 2021, RIGHT HIP.
Patient problems: Ambulation or Postural Difficulties; Cyst(s); Discomfort; Extraskeletal ossification; Foreign Body Reaction; Inadequate Osseointegration; Loss of Range of Motion; Metal Related Pathology; Osteolysis; Pain; Swelling/ Edema; Unspecified Tissue Injury
MAUDE report 11575407 ↗
Other Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium 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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