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CORAIL L98015Recalls & reported problems

Depuy (Ireland) · CORAIL HIP SYSTEM CEMENTLESS FEMORAL STEM HA COATED REVISION 12/14 AMT 135 DEGREES STANDARD COLLAR SIZE 15 · Class 2 · Implant

Adverse event reports
6
Deaths reported
0
Injuries reported
6
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295262343), received between Sep 11, 2018 and Mar 28, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

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 Problem3
  • Fracture2
  • Material Deformation1

Patient problems

  • Limb Fracture2
  • Pain2
  • Bone Fracture(s)1
  • Cardiac Arrest1
  • Infarction, Cerebral1
  • Malunion of Bone1
  • No Clinical Signs, Symptoms or Conditions1
  • No Code Available1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THIS PC CAPTURES THE REVISION SURGERY, WHILE (B)(4) CAPTURES THE INTRA-OP EVENT. REVISION COMPLETED TO ADDRESS PAIN AND PSEUDOARTHROSIS.

    Patient problems: Malunion of Bone; Pain

    MAUDE report 13930667 ↗
  • InjuryJan 28, 2022Material Deformation; Material Deformation

    IT WAS REPORTED THAT STEM DISTAL SLOTS DEFORMED INTRO-OP. THE PATIENT UNDERWENT THE HIP REVISION SURGERY WITH CORAIL REVISION STEM. DURING THE SURGERY, IT WAS FOUND THAT THE STEM DISTAL SLOT PASSED OUT OF THE FEMUR AND THE DISTAL SLOT WAS DEFORMED. THEN THE SURGEON REMOVED THE DEFORMED STEM TIMELY AND USED ANOTHER REVISION STEM TO COMPLETE THE SURGERY. THE PATIENT WAS STABLE NOW.

    Patient problems: Limb Fracture

    MAUDE report 13384493 ↗
  • InjuryDec 17, 2021Fracture; Fracture

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE EXAMINATION OF THE PROVIDED X-RAY IMAGE SHOWED THAT THE DISTAL TIP OF THE STEM HAS PERFORATED THE PATIENT'S FEMORAL BONE.

    Patient problems: Limb Fracture; No Clinical Signs, Symptoms or Conditions

    MAUDE report 13025081 ↗
  • InjuryApr 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT PATIENT HAD PAIN. DOI: UNKNOWN DOR: (B)(6) 2021 RIGHT HIP.

    Patient problems: Pain

    MAUDE report 11733784 ↗
  • InjuryJun 12, 2020Fracture; Fracture

    DEFORMED CORAIL REVISION STEM AND TRIAL AFTER IMPLANTING. ONE OF THE DISTAL PARTS IS GOING OUTSIDE THE BONE BECAUSE OF A VIA FALSA.

    Patient problems: Bone Fracture(s); No Code Available; Not Applicable

    MAUDE report 10148485 ↗
  • InjurySep 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES HEART ATTACK/STROKE. DOI: (B)(6) 2015, DOR: NONE REPORTED (RIGHT HIP).

    Patient problems: Cardiac Arrest; Infarction, Cerebral

    MAUDE report 7863666 ↗

Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices

All Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices →

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