CORAIL L98114Recalls & reported problems
Depuy (Ireland) · CORAIL HIP SYSTEM CEMENTLESS FEMORAL STEM HA COATED REVISION 12/14 AMT 135 DEGREES HIGH OFFSET COLLAR SIZE 14 · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295262428), received between Apr 20, 2018 and Oct 22, 2025 — classified as 7 injuries.
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
- Adverse Event Without Identified Device or Use Problem4
- Break1
- Fracture1
- Migration1
- Osseointegration Problem1
Patient problems
- Unspecified Infection4
- Inadequate Osseointegration2
- Insufficient Information1
- No Consequences Or Impact To Patient1
- Not Applicable1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryOct 22, 2025Fracture; Fracture
IT WAS REPORTED THAT PATIENT UNDERWENT REVISIONS DUE TO A BROKEN CORAIL. DOI: UNKNOWN 215, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.
Patient problems: Insufficient Information
MAUDE report 23359480 ↗InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ALL COMPONENTS WERE REVISED DUE TO INFECTION. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 18139629 ↗InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PROSTHESIS WAS REMOVED DUE TO INFECTION. NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 14471311 ↗InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION COMPLETED DUE TO INFECTION. DOI: UNK. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 14468963 ↗InjuryMar 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED TO ADDRESS INFECTION. SURGEON DECIDED TO REMOVE ALL IMPLANTS AND FIGHT THE INFECTION WITH ANTIBIOTICS AND ANTIBIOTIC BEADS. HE PLANS TO RETURN AND RE IMPLANT. THERE IS NO MORE INFORMATION. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 13684890 ↗InjuryJan 6, 2021Osseointegration Problem; Migration; Osseointegration Problem; Migration
IT WAS REPORTED THAT THE STEM HAS SUBSIDED AND WAS LOOSE. ORIGINAL SURGERY WAS (B)(6) 2020 AND 1ST REVISION WAS (B)(6) 2020. NO SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT HIP.
Patient problems: Inadequate Osseointegration
MAUDE report 11123630 ↗InjuryApr 20, 2018Break; Break
REVISION OF CORAIL STEM BECAUSE OF FRACTURE OF DISTAL SLOTTED PARTS. DOI: (B)(6) 2011, (B)(6), DOR: (B)(6) 2018; UNKNOWN HIP.
Patient problems: Inadequate Osseointegration; No Consequences Or Impact To Patient; Not Applicable
MAUDE report 7446292 ↗
Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 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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