CORAIL 3L92498Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 10603295168645), received between Aug 3, 2017 and Jan 16, 2026 — classified as 53 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (19 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

Recent adverse event reports

The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR PAIN. DOI: (B)(6) 2021. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 24101608 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 23325770 ↗
• MalfunctionAug 12, 2025Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  REPORTED PATIENT UNDERWENT ARTHROPLASTY. THE SIZE 8 COLLARED CORAIL OUTER PEEL PACK WASN¿T SEALED ON ONE SIDE AND FELL ON THE GROUND AS IT WAS HANDED TO NURSE TO OPEN AND AS SHE BROKE THE ANGLED SEAL SIDE IT SLID OUT THE BOTTOM OF THE UNSEAL PORTION AND FELL ONTO THE FLOOR. DECIDED AT THAT POINT TO JUST GRAB ANOTHER STEM TO OPEN. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22781918 ↗
• MalfunctionAug 1, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT, THE CORAIL STEM DIDN'T FIT INTO BIOLOX CERAMIC HEAD. THEREFORE THE SURGEON CHANGED FOR ANOTHER STEM AND IT WORKED FINE. SURGERY WAS DELAYED BY FIVE MINUTES DUE TO THE EVENT AND WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22685795 ↗
• InjuryJun 23, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE SZ 8 KA CORAIL STEM WAS LOOSE AND WAS REMOVED IN REVISION SURGERY. THE LOOSENING OCCURRED BETWEEN THE STEM AND THE FEMUR. THERE WAS NO PROBLEM WITH THE HEAD. IT WAS EXCHANGED AS THE STEM WAS REVISED.

  Patient problems: Inadequate Osseointegration; Inflammation; Pain

  MAUDE report 22307738 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRODUCTS WERE TOO LONG. REVISED TO SHORTEN. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Physical Asymmetry

  MAUDE report 22282971 ↗
• InjuryApr 23, 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 INFECTION. SURGEON REMOVED ALL IMPLANTS AND REPLACED WITH TEMPORARY SPACER. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21892072 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED ON (B)(6) 2024. THE STEM, HEADBALL AND LINER WAS REPLACED DUE TO INSTABILITY. THE RESULT OF INSTABILITY IS UNKNOWN. SURGICAL DELAY WAS UNKNOWN. DATE OF IMPLANT WAS (B)(6) 2023.

  Patient problems: Joint Laxity

  MAUDE report 20632500 ↗
• InjuryApr 29, 2024Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO STEM LOOSENING. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP. ADDITIONAL EVENT INFORMATION: LOOSENING AT THE STEM BONE INTERFACE. THERE WAS NO DELAY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19206647 ↗
• InjuryDec 8, 2023Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO THE LOOSENING OF THE STEM AS IT WAS UNDERSIZED. UNKNOWN SURGICAL DELAY. DOI: (B)(3) 2018. DOR: (B)(3) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18291287 ↗
• InjuryDec 7, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT HAD LOOSENING. THERE WAS NO INFECTION, SAME SIZE ON CONTRALATERAL SIDE FAIRING WELL. (B)(6) AFFECTED SIDE: RIGHT HIP

  Patient problems: Inadequate Osseointegration

  MAUDE report 18283540 ↗
• InjuryDec 7, 2023Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO STEM LOOSENING AND NEEDED TO BE REPLACED. ADDITIONAL INFO RECEIVED FROM SALES REP STATED: THE STEM WAS LOOSE IN THE CANAL. IT IS POSSIBLE THAT THE STEM WAS UNDERSIZED IN THE INITIAL SURGERY AS IT CAME OUT QUITE EASY AND THERE DIDN'T APPEAR TO BE MUCH ON GROWTH ONTO THE STEM. DOI: (B)(6), 2020. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18283379 ↗
• InjuryOct 6, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT HAS COMPLAINED OF THEIR HIP HURTING, AFTER A BONE SCAN IT SHOWED THE CORAIL STEM WAS LOOSE. ALL TISSUE LOOKED NORMAL WITH NO APPARENT INFECTION PRESENT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2015 DOR: (B)(6) 2023 AFFECTED SIDE: UNKNOWN HIP SIDE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 17886643 ↗
• InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 17885854 ↗
• InjuryApr 5, 2023Osseointegration Problem; Osseointegration Problem

  REVISED A CORAIL STEM TODAY THAT HAD BEEN UNDERSIZED AND HAD LOOSENED. REVISION WENT WELL. SURGEON HAPPY WITH OUTCOME.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16681974 ↗
• InjuryMar 14, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration

  MEDICAL RECORDS RECEIVED INDICATE THAT ON (B)(6) 2018: THE PATIENT UNDERWENT A LEFT THA WITH DEPUY IMPLANTS PLACED. IT WAS REPORTED THE PATIENT FELL SEVERAL YEARS LATER AND HAS EXPERIENCED PAIN WITH PROGRESSIVE LOOSENING. (B)(6) 2023: PATIENT UNDERWENT A LEFT THA REVISION FOR PAIN, 3CM LIMB DISCREPANCY, DECREASED ROM, POTENTIAL INFECTION, AND FEMORAL STEM LOOSENING AND SUBSIDENCE. BMI-27.98 HEIGHT: 5'4".

  Patient problems: Fall; Inadequate Osseointegration; Loss of Range of Motion; Pain; Physical Asymmetry; Unspecified Infection

  MAUDE report 16537043 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION PAPERS ALLEGE PAIN, DISCOMFORT, AND ELEVATED METAL ION LEVELS. UPDATE 07/15/13 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOB AND PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

  Patient problems: Anxiety; Deformity/ Disfigurement; Discomfort; Distress; Foreign Body Reaction; Metal Related Pathology; Osteolysis; Pain; Thrombosis/Thrombus

  MAUDE report 15986152 ↗
• InjuryAug 29, 2022Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF FEMORAL COMPONENT AT THE BONE TO IMPLANT INTERFACE.. NEW STEM AND HEAD IMPLANTED AND SWAPPED LINER. NO OTHER INFORMATION IS AVAILABLE. THERE WAS NO SURGICAL DELAY. DOI- (B)(6) 2011. DOR- (B)(6) 2022. AFFECTED SIDE- LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15313568 ↗
• InjuryFeb 8, 2022Osseointegration Problem; Migration; Osseointegration Problem; Migration

  REVISION COMPLETED DUE TO LOOSENING, SUBSIDING, AND MICROMOTION. IT IS WAS SUSPECTED THE STEM WAS UNDERSIZED. STEM WAS REMOVED, PREPPED FOR AND IMPLANTED CORAIL REVISION STEM WITH REPLACEMENT HEAD. DOI: (B)(6) 2021, DOR: (B)(6) 2022, RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13481766 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT THE THA SURGERY FOR LEFT HIP. AFTER THE SURGERY, SIGNS OF STRESS SHIELDING DEVELOPED AT THE BONE AROUND THE DISTAL STEM DUE TO LOADING. ON UNKNOWN DATE, REVISION SURGERY WAS PERFORMED. IN THE REVISION SURGERY, THE IMPLANTS USED IN THE FIRST SURGERY WERE REMOVED AND REPLACED WITH OTHER COMPANY¿S IMPLANTS. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. DOI: (B)(6) 2018, DOR: UNKNOWN, LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Tissue Injury

  MAUDE report 12540654 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. DOI: (B)(6) 2013. DOR: (B)(6) 2021. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12212247 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN IN THIGH SO THE DOCTOR REVISES STEM AND CUP. DOI: (B)(6) 2015 - DOR: (B)(6) 2021, (RIGHT HIP).

  Patient problems: Pain

  MAUDE report 12163792 ↗
• InjuryApr 26, 2021Osseointegration Problem; Osseointegration Problem

  SUBJECT ID: 017-03844. STUDY: DOTS . CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL HIP TO ADDRESS ADVERSE LOCAL TISSUE REACTION DATE OF IMPLANTATION: (B)(6) 2013. DATE OF REVISION: (B)(6) 2021. (LEFT HIP). ON (B)(6) 2021, THE PATIENT UNDERWENT A LEFT HIP REVISION TO ADDRESS FEMORAL STEM LOOSENING AT THE BONE TO IMPLANT INTERFACE. THE SURGEON NOTED THE REMOVAL OF FIBROUS TISSUE. THE STEM, HEAD, AND LINER WERE REVISED. THE CUP AND SCREW WERE RETAINED. THE PATIENT WAS REVISED WITH DEPUY PRODUCTS. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS.

  Patient problems: Adhesion(s); Foreign Body Reaction; Inadequate Osseointegration

  MAUDE report 11723927 ↗
• InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED HIP. ALL COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED. DOI: (B)(6) 2018, DOR: (B)(6) 2021, LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11437236 ↗
• InjuryDec 10, 2020Inadequacy of Device Shape and/or Size; Osseointegration Problem; Inadequacy of Device Shape and/or Size; Osseointegration Problem

  IT WAS REPORTED THAT THE STEM WAS UNDERSIZED AND LOOSE AT BONE TO IMPLANT INTERFACE, THE SURGEON REMOVED THE CORAIL STEM AND REPLACED WITH NEW STEM, HEAD AND LINER. DOI: (B)(6) 2017: DOR: (B)(6) 2020: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10984822 ↗