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CORAIL L971312Recalls & reported problems

Depuy (Ireland) · CORAIL HIP SYSTEM CEMENTLESS FEMORAL STEM HA COATED 12/14 AMT 135 DEGREE SHORT NECK COLLAR SIZE 12 · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295478690), received between Mar 23, 2021 and May 26, 2023 — classified as 2 injuries.

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.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2

Patient problems

  • Limb Fracture2
  • Fall1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON (B)(6) 2023, THE PRIMARY SURGERY WAS PERFORMED VIA BHA WITH THE PRODUCT IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON AN UNKNOWN DATE, WHEN THE PATIENT WENT TO SEE THE DOCTOR COMPLAINING OF PAIN, DISLOCATION WAS FOUND. MANUAL REPAIR WAS PERFORMED, BUT THE SHORTENING SEEMED TO HAVE PROGRESSED AND RESULTED IN A FEMUR FRACTURE. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. THE SURGEON REMOVED THE STEM WHICH WAS NOT STABLE ENOUGH. HE FIXED THE AFFECTED AREA WITH A PLATE AND CABLE AND CEMENTED A K-WIRE AND INSERTED IT AS AN INTRAMEDULLARY NAIL FINISHING THE SURGERY AS GIRDLESTONE. HE COMMENTED THAT THERE WOULD BE NO CAUSAL RELATIONSHIP WITH THE IMPLANT AND IT MAY BE DUE TO THE CHARACTERISTICS OF THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

    Patient problems: Limb Fracture

    MAUDE report 17010599 ↗
  • InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRIMARY SURGERY WAS PERFORMED WITH THE STEM. ON AN UNKNOWN DATE, THE PATIENT FELL, AND THE FRACTURE AROUND THE STEM OCCURRED. ON AN UNKNOWN DATE, THE REVISION SURGERY WAS PERFORMED DUE TO THE FRACTURE AROUND THE STEM. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Fall; Limb Fracture

    MAUDE report 11552723 ↗

Other Prosthesis, hip, hemi-, femoral, metal devices

All Prosthesis, hip, hemi-, femoral, metal devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.