CORAIL L971308Recalls & reported problems
Depuy (Ireland) · CORAIL HIP SYSTEM CEMENTLESS FEMORAL STEM HA COATED 12/14 AMT 135 DEGREES SHORT NECK COLLAR SIZE 8 · Class 2 · Implant
All models of CORAIL (121)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295455424), received between Dec 2, 2021 and Jan 9, 2025 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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 Problem4
- Tear, Rip or Hole in Device Packaging1
Patient problems
- Unspecified Infection2
- Limb Fracture1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO A FEMUR FRACTURE. SURGICAL DELAY WAS UNKNOWN. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Limb Fracture
MAUDE report 21117990 ↗InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT THE PRIMARY SURGERY. ON (B)(6)2024, THE SALES REP WAS INFORMED THAT THE PATIENT WAS UNDER FOLLOW-UP AFTER BEING TREATED FOR DEBRIDEMENT DUE TO AN INFECTION. ON (B)(6) 2024, IT WAS CONFIRMED THAT THE DEBRIDEMENT TREATMENT WAS PERFORMED ON BOTH THE LEFT AND RIGHT SIDE. AND THE TREATMENT DATE WAS (B)(6) 2024. IN ADDITION, NO REVISION OF THE IMPLANTS WAS PERFORMED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Unspecified Infection
MAUDE report 19100091 ↗InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT THE PRIMARY SURGERY. ON APR. 1, 2024, THE SALES REP WAS INFORMED THAT THE PATIENT WAS UNDER FOLLOW-UP AFTER BEING TREATED FOR DEBRIDEMENT DUE TO AN INFECTION. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Unspecified Infection
MAUDE report 19088547 ↗MalfunctionDec 15, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PACKAGE IS NOT FIXATION WITH IMPLANTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15987932 ↗InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2020; DOE: (B)(6) 2021 RIGHT HIP.
Patient problems: Pain
MAUDE report 12916486 ↗
Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices
- STAGEONE 431209Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 recalls0 reports
- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 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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