CORAIL L971116Recalls & reported problems
Depuy (Ireland) · CORAIL HIP SYSTEM CEMENTLESS FEMORAL STEM HA COATED 12/14 AMT 135 DEGREES HIGH OFFSET COLLAR SIZE 16 · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295455356), received between Sep 13, 2018 and Nov 5, 2024 — classified as 3 injuries, 2 malfunctions.
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. 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 Problem1
- Fracture1
- Incomplete or Missing Packaging1
- Loss of Osseointegration1
- Packaging Problem1
Patient problems
- Inadequate Osseointegration1
- Insufficient Information1
- No Code Available1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT UNDERWENT REVISION HIP SURGERY ON (B)(6) 2024. PATIENT WAS REVISED DUE TO INFECTION. SURGEON REMOVED AND IMPLANTED A PROSTALAC. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 20613760 ↗InjuryAug 2, 2021Fracture; Fracture
InjuryNov 18, 2020Loss of Osseointegration; Loss of Osseointegration
PATIENT EXPERIENCING FEMORAL PAIN FROM LOOSE CORAIL STEM. CORAIL STEM WAS REVISED USING CORAIL EXTRACTION INSTRUMENT SET AND FEMORAL ETO. PRIMARY HIP REPLACEMENT WAS PERFORMED ON (B)(6) 2016.
Patient problems: Inadequate Osseointegration; No Code Available; Pain
MAUDE report 10860219 ↗MalfunctionSep 17, 2019Incomplete or Missing Packaging; Incomplete or Missing Packaging
IT WAS REPORTED THAT THE LABELING ON IMPLANT IS NOT CONSISTENT WITH ORIGINAL CORAIL IMPLANT LABELING ON STEM. SLOWS DOWN FLOW.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9075571 ↗MalfunctionSep 13, 2018Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE SURGEON FOUND THAT COVER FILM OF THE STEM NECK WAS DAMAGED WHEN THE SURGEON OPENED THE PACKAGE DURING THE THA SURGERY ON (B)(6) 2018. THE SURGEON DECIDED NOT TO USE THE STEM BECAUSE THE COVER FILM FRAGMENT WAS SCATTERED IN THE PACKAGE. THE SURGERY WAS COMPLETED BY USING ALTERNATIVE STEM (P/N AND LOT NUMBER WERE UNKNOWN). THERE WAS LESS THAN 30 MINUTES SURGICAL DELAY AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7872227 ↗
Other Prosthesis, hip, hemi-, femoral, metal devices
- UHR UH1-48-28Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal2 recalls3 reports
- "UNITED" USTAR II Knee System 2515-3213United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3115United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- STAGEONE 431207Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3111United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- ACTIS 101011050Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal73 reports
- UHR UH1-46-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 reports
- UHR UH1-45-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 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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