CORAIL 3L92503Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 10603295168690), received between Jan 9, 2017 and Jul 1, 2026 — classified as 73 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (14 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 78 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2026Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF STEM AND PAIN AT NON CEMENTED INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 25677201 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD A HISTORY OF A METAL-METAL ARTICULATING TOTAL HIP ARTHROPLASTY OF THE RIGHT HIP. ON (B)(6) 2024, AN MRI OF THE RIGHT HIP REVEALED THE PRESENCE OF FLUID COLLECTION EMANATING FROM THE JOINT. LABORATORY EVALUATION DEMONSTRATED ELEVATED PLASMA METAL ION LEVELS. ON (B)(6) 2026, THE PATIENT UNDERWENT REVISION SURGERY OF THE RIGHT TOTAL HIP ARTHROPLASTY DUE TO MECHANICAL FAILURE SECONDARY TO METAL HYPERSENSITIVITY, RESULTING IN AN ADVERSE LOCAL TISSUE REACTION (ALTR). DOI: (B)(6) 2009. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Hypersensitivity/Allergic reaction; Metal Related Pathology; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 25046418 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS WERE REMOVED DUE TO INFECTION, WASHED OUT AND PUT NEW IMPLANTS IN. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23453125 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND FRACTURED FEMUR. THE SURGEON REVISED WITH COMPETITOR'S REST MOD AND USED OUR DM LINER. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 23328654 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AT HOME AND FRACTURED HER FEMUR. THE SURGEON REVISED THE STEM TO A MODULAR LONGER STEM CONSTRUCT AND SWITCHED THE LINER OUT TO DUAL MOBILITY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 22904110 ↗
• InjuryAug 21, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE PATIENT FELL, WHICH CAUSED LOOSENING AND SUBSIDENCE OF IMPLANTED CORAIL STEM. REVISION WAS PERFORMED.

  Patient problems: Fall; Inadequate Osseointegration

  MAUDE report 22859623 ↗
• InjuryApr 21, 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 HAVING PAIN AND INFECTION. STEM, POLY, HEAD WERE TAKEN OUT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 21872076 ↗
• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REVISED DUE TO INFECTION. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20258854 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED, FOR PERIPROSTHETIC FEMUR FRACTURE. OBSERVED, 3 WEEKS POST-OP. NO KNOWN FALLS OR TRAUMA. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 20153464 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Limb Fracture

  MAUDE report 19751015 ↗
• InjuryJun 3, 2024Use of Device Problem; Osseointegration Problem; Use of Device Problem; Osseointegration Problem

  THE LOOSE INTERFACE WAS THE CUP AND THE ACETABULUM.

  Patient problems: Inadequate Osseointegration; Joint Laxity

  MAUDE report 19454952 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER THE PATIENT FELL, THE FEMUR FRACTURED AND THE STEM WAS REVISED. THERE WAS NO DELAY. AFFECTED SIDE: LEFT

  Patient problems: Fall; Limb Fracture; Pain

  MAUDE report 19267429 ↗
• InjuryFeb 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 18767284 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND BROKE GREATER TROCH/LESSER TROCH. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(6) 2023. AFFECTED SIDE- UNKNOWN HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 18092871 ↗
• InjuryAug 18, 2023Fracture; Fracture

  LITIGATION RECORDS AD 3&4 (B)(6) 2023 ALLEGES ON (B)(6) 2021, THE DEPUY CORAIL® STEM AT THE NECK ON THE PATIENT'S RIGHT HIP, WITHOUT WARNING, SUDDENLY AND CATASTROPHICALLY FRACTURED AT THE NECK WHILE PATIENT WAS SIMPLY WALKING. PATIENT SUFFERED SIGNIFICANT DAMAGES INCLUDING, BUT NOT LIMITED TO PHYSICAL INJURY, ECONOMIC LOSS, PAIN AND SUFFERING, AND WILL CONTINUE TO SUFFER DAMAGES INTO THE FORESEEABLE FUTURE. DOI: (B)(6) 2011. DOE: (B)(6) 2021. DOR: (B)(6) 2021. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity; Loss of Range of Motion; Numbness; Pain

  MAUDE report 17573016 ↗
• InjuryJul 7, 2023Osseointegration Problem; Osseointegration Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO ASEPTIC LOOSENING. DATE OF IMPLANT: (B)(6) 2020. DATE OF REVISION: (B)(6) 2023. (LEFT HIP). TREATMENT: STEM AND HEAD WERE REVISED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17277569 ↗
• MalfunctionJun 28, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT UPON OPENING THE IMPLANT, IT WAS OBSERVED THAT THE CORAIL STEMS HAD BROWN MARKS IN THE IMPLANT COVER. THERE WAS A SURGICAL DELAY FOR 3-5 MINS.

  Patient problems: Insufficient Information

  MAUDE report 17219245 ↗
• InjuryJun 26, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED FOR ASEPTIC LOOSENING OF THE FEMORAL STEM. REVISED STEM/HEAD. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17198253 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023. DOR: APR 17, 2023 AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 16831765 ↗
• InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD CORAIL AND PINNACLE IMPLANTED IN (B)(6) 2022 AT ANOTHER FACILITY, SUBSEQUENTLY HAD SPINAL FUSION AND HAS DISLOCATED TWICE AND ALSO SHOWN SIGNS OF INFECTION AROUND THE JOINT AND DISTAL FEMORAL IMPLANT. THIS REQUIRED REVISION SURGERY TO REMOVE THE IMPLANT AND REPLACE WITH CORAIL REVISION STEM AND CEMENTED BIMENTUM CUP. PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?: INFECTION, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES, IF YES, DESCRIBE: XRAYS, REVISION SURGERY. IS THE PATIENT PART OF A CLINICAL STUDY: NO. (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.: TRUE.

  Patient problems: Unspecified Infection

  MAUDE report 16806480 ↗
• InjuryApr 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PERI PROSTHETIC FRACTURE FROM A FALL. DOI: (B)(6) 2023. DOR: APR 3, 2023. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Fall; Limb Fracture

  MAUDE report 16768198 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION AND ALL IMPLANTS WERE REMOVED. DOI: (B)(6), DOR: (B)(6), AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16743661 ↗
• InjuryJan 9, 2023Osseointegration Problem; Osseointegration Problem

  REVISION OF CORAIL STEM AND HEAD DUE TO PERI-PROSTHETIC FRACTURE AT (B)(6) HOSPITAL BY DR. THE STEM WAS LOOSE WHEN THE HIP WAS OPENED AND THE HEAD AND STEM CAME OUT TOGETHER. CUP WAS LIMA. ZIMMER STEM WAS INSERTED. DOI: (B)(6) 2011. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 16120899 ↗
• InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 15880153 ↗
• InjurySep 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT IS INFECTED AND WE ARE EXPLANTING COMPONENTS AND PUTTING IN A CEMENT SPACER. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15493219 ↗