CORAIL L20318Recalls & reported problems
Depuy (Ireland) · CORAIL HIP SYSTEM CEMENTLESS FEMORAL STEM 12/14 AMT 135 DEGREES KHO SIZE 18 HA COATED HIGH OFFSET NO COLLAR · Class 2 · Implant
All models of CORAIL (121)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295258087), received between Mar 28, 2023 and Jun 6, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Fracture” (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
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
- Migration1
- Off-Label Use1
- Osseointegration Problem1
Patient problems
- Insufficient Information1
- Joint Laxity1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 6, 2024Osseointegration Problem; Osseointegration Problem
PATIENT WAS REVISED DUE TO INFECTION. THERE WAS A LOOSENING REPORTED AT STEM. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE : RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 19477687 ↗InjuryMar 29, 2023Fracture; Fracture
HCP REPORTED TO BFARM/NCA: " CONDITION AFTER IMPLANTATION OF A CEMENTLESS HIP TEP (B)(6)2017 (PINNACLE CUP SIZE: 58, INLAY: 32, CORAIL-STEM SIZE: 18 HIGH OFFSET, HEAD SIZE: +9 CERAMIC). CONDITION AFTER CHANGE OF HIP-TEP LEFT TO MERETE 4XL PLUS 32 CERAMIC HEAD BECAUSE OF INSTABILITY UNDER STEM SINTERING ON (B)(6) 2018. CURRENT REPORTABLE EVENT: FRACTURE OF THE CORAIL STEM (DEPUY SYNTHES) BELOW THE HEAD ADAPTER."
Patient problems: Insufficient Information
MAUDE report 16634668 ↗InjuryMar 28, 2023Off-Label Use; Adverse Event Without Identified Device or Use Problem; Migration; Off-Label Use; Adverse Event Without Identified Device or Use Problem; Migration
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THE FOLLOWING: THE INLAY WAS NOT REVISED IN (B)(6) 2019. THE HIP STEM WAS SINTERED PREOPERATIVELY. INTRAOPERATIVELY, THERE WAS NO CHANGE IN POSITION OR LOOSENING OF THE STEM. REVISION ONLY OF THE COMPETITOR´S HIP HEAD TO ANOTHER (LONGER) COMPETITOR´S HIP HEAD. THERE WAS NO REVISION OF THE HIP STEM.
Patient problems: Joint Laxity
MAUDE report 16626519 ↗
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 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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