CORAIL 3L92507Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 10603295168737), received between Sep 20, 2017 and Feb 19, 2026 — classified as 63 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (20 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2026Osseointegration Problem

  IT WAS REPORTED THAT SOME TIME AGO THE PATIENT HAD A HIP REPLACEMENT AND STEM CAME LOOSE. STEM WAS REVISED WITH A NON-DEPUY SYNTHES STEM WITHOUT INCIDENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24389391 ↗
• InjuryJul 31, 2025Migration; Migration

  IT WAS REPORTED THAT THE SURGEON REVISED A THR WITH CORAIL PINNACLE INSITU TO AN S-ROM REVISION STEM AND RETAINED PINNACLE ACETABULAR CUP. THE ORIGINAL STEM WAS UNCOLLARED SUBSIDED. LINER AND HEAD WERE ALSO REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674710 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THERE WAS A PERIPROSTHETIC FRACTURE WHERE THE CORAIL STEM WAS REMOVED. THE HA COATING WAS MISSING.

  Patient problems: Limb Fracture

  MAUDE report 22385398 ↗
• InjuryJul 16, 2024Osseointegration Problem; Osseointegration Problem

  REVISION DUE TO PAIN AND LOOSENING. DOI: (B)(6) 2016; DOE: (B)(6) 2024.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 19752865 ↗
• InjuryMay 16, 2024Osseointegration Problem; Osseointegration Problem

  PRIMARY PROCEDURE AT ANOTHER HOSPITAL, UNABLE TO GET ACCURATE SURGERY DATE. PATIENT HAD A FALL, SHE HAD A PERIPROSTHETIC FRACTURE WHICH WAS TREATED CONSERVATIVELY. SHE HAS BEEN EXPERIENCING PAIN AND THIS IS BELIEVED TO BE DUE TO THE STEM NOW BEING LOOSE WITHIN THE FEMUR. REVISION SURGERY CARRIED OUT WITH SIZE 8 KS CORAIL STEM REMOVED USING A XTRACTION BOLT AND SLAP HAMMER, DIDN¿T NEED TO USE LONG K-WIRES OR FLEXIBLE OSTEOTOMES TO UNDERMINE ANY FIXATION. FEMUR WAS THEN PREPPED AND REPLACED WITH CORAIL REVISION STEM SIZE 10 STANDARD. PRIMARY CERAMIC LINER REPLACED WITH PINNACLE DUAL MOBILITY LINER, CUP REMAINED INSITU.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture; Pain

  MAUDE report 19332787 ↗
• InjuryApr 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR REVISION ASR XL LEFT HIP REASON FOR REVISION: PAIN. DOI: (B)(6) 2009; DOR: (B)(6) 2024; LEFT HIP.

  Patient problems: Pain

  MAUDE report 19081453 ↗
• InjuryJan 31, 2024Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL STEM AT UNKNOWN INTERFACE. DOI- UNKNOWN. DOR- JANUARY 25, 2024. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18613280 ↗
• MalfunctionJan 29, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PACKAGING WAS DAMAGED UPON RECEIPT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18603008 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POST-OP THROMBUS. THIS CASE IS FROM THE HEALTH AUTHORITY. IT WAS REPORTED THAT ON THE FIRST DAY AFTER SURGERY, A FOLLOW-UP ULTRASOUND WAS PERFORMED ON THE LEFT LOWER LIMB BLOOD VESSELS. AT 22:37, IT WAS FOUND THAT THERE WAS A PARTIAL INTERMUSCULAR THROMBOSIS IN THE LOWER LEG OF THE LEFT LOWER LIMB. FOLLOWING THE DOCTOR'S ADVICE, THE LOWER LIMB PNEUMATIC PUMP TREATMENT WAS STOPPED, AND ONE TABLET OF RIVAROXABAN [J] [20MG] WAS CONTINUED ORALLY. THE PATIENT WAS ADVISED TO DRINK AT LEAST 2000ML OF WATER DAILY, AND TO CONTINUE TO STRENGTHEN ANKLE PUMP EXERCISE, QUADRICEPS MUSCLE RELAXATION AND CONTRACTION ACTIVITIES, AND OTHER REHABILITATION EXERCISES.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18319426 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR A PERIPROSTHETIC FRACTURE AND PAIN, FOLLOWING A FALL. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT.

  Patient problems: Bone Fracture(s); Fall; Pain

  MAUDE report 17859724 ↗
• MalfunctionSep 27, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AT THE RECEIPT OF THE DEVICE, IT WAS NOTICED THAT ITS PACKAGING IS DAMAGED. THE PLASTIC FILM IS NOT TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17826177 ↗
• InjurySep 25, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN AND UNDERWENT A REVISION. DURING REVISION, CORAIL STEM WAS FOUND TO BE LOOSE, IT WAS REMOVED AND REPLACED. SURGICAL DELAY OF 70 MINUTES WAS REPORTED.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 17807015 ↗
• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR NOTIFICATION RECEIVED. THE PATIENT HAD HIS LEFT HIP ASR IMPLANTS REVISED DUE TO PAIN. DOI: (B)(6), 2009; DOR: (B)(6), 2023; LEFT HIP.

  Patient problems: Pain

  MAUDE report 17775017 ↗
• InjuryJul 20, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO MILD METALLOSIS WITH LOOSENING OF FEMORAL STEM. THE LOOSENING INTERFACE WAS NON-CEMENTED. DOI: (B)(6) 2008. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration

  MAUDE report 17360869 ↗
• InjuryJul 11, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO STEM WAS UNDERSIZED AND LOOSE AT NON-CEMENTED INTERFACE. ALSO BONE NEVER GREW ONTO IMPLANT. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17299101 ↗
• InjuryJun 12, 2023Fracture; Fracture

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE WAS A SURGICAL DELAY IN THE REVISION FOR ABOUT +45 MINUTES.

  Patient problems: Insufficient Information; Pain

  MAUDE report 17105954 ↗
• InjuryMar 31, 2023Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND CONFIRMED THAT THERE WERE NO ADVERSE CONSEQUENCES REPORTED. FOLLOWING UP WITH THE SURGEON A FEW WEEKS AGO AND SAYS THAT THEY WERE DOING WELL.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16655275 ↗
• InjuryFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED. INDICATED, THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Limb Fracture

  MAUDE report 16351077 ↗
• InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR XL CLAIMSUITE RECEIVED. PATIENT WAS REVISED WAS DUE TO PAIN. DOI: (B)(6) 2008. DOR: (B)(6) 2022. RIGHT HIP.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 16101546 ↗
• InjuryOct 31, 2022Osseointegration Problem; Osseointegration Problem

  REVISION OF CORAIL STEM AND LINER CHANGE (STEM TOO SMALL AND LOOSE, LINER CHANGED IN ORDER TO GET A BIGGER HEAD INSIDE). DOI: UNKNOWN; DOR: (B)(6) 2022; UNKNOWN SIDE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15698736 ↗
• InjurySep 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS MOM THA, ELEVATED METAL IONS RESULTING TO PAIN AND WALKING DIFFICULTY. OPERATIVE NOTE REPORTED, PSEUDOTUMOR, THERE WAS A SMALL POSTERIOR CAPSULAR DEFECT FROM THE PREVIOUS APPROACH. THERE WAS TRUNNIONOSIS IN THE HEAD HOWEVER, THERE WAS NO EVIDENCE OF WEAR. DOI: (B)(6) 2009. DOR: (B)(6) 2014. RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Hypersensitivity/Allergic reaction; Metal Related Pathology; Pain

  MAUDE report 15494565 ↗
• InjurySep 9, 2022Use of Device Problem; Osseointegration Problem; Migration; Use of Device Problem; Osseointegration Problem; Migration

  IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT THE TOTAL HIP ARTHROPLASTY WITH THE STEM AND THE LINER FOR THE OSTEOARTHRITIS OF THE RIGHT HIP JOINT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. TWO YEARS AFTER THE SURGERY, ALTHOUGH THE STEM STARTED TO SINK, THE PATIENT DID NOT COMPLAIN OF PAIN. THE SURGEON WAS FOLLOWING UP THE PATIENT. IN 2022, THE PATIENT COMPLAINED OF PAIN, AND THE STEM WAS SUNK AND WAS RETRO-TWISTING. THEREFORE, THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2022. THE STEM WAS LOOSENED, AND THE LINER WAS NOT LOCKED TO THE CUP. THE PART OF THE LINER WAS FLOATING. THE STEM WAS REPLACED WITH OTHER COMPANY¿S STEM, AND THE LINER WAS REPLACED WITH A NEW LINER. ACCORDING TO THE SURGEON, THE STEM SEEMED TO BE SLIGHTLY SMALL. THE STEM WAS COLLAR-LESS, SO THAT THE SURGEON COMMENTED THAT HE SHOULD HAVE CHOSEN ONE SIZE LARGER STEM FOR FIXATION. THE STEM BEGAN TO RETRO-TWIST WITH SINKING. SINCE THE LINER WAS NOT BROKEN AND DEFORMED, THE LINER WAS MOST LIKELY NOT CORRECTLY LOCKED AT THE PRIMARY SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 15393877 ↗
• InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT DUE TO PRIMARY LOCALIZED ARTHROSIS OF THE LEFT HIP RECEIVED A DEPUY IMPLANT ON (B)(6) 2020 FOR TOTAL HIP REMOVAL. ON (B)(6) 2020 THE PATIENT WAS HOSPITALIZED FOR REVISION SURGERY DUE TO UNSPECIFIED MECHANICAL COMPLICATIONS OF THE IMPLANT. IT REFERS TO MOBILIZATION OF THE IMPLANT. IN HISTORY REPORTED EPISODES OF SUBLUXATION AND LOADING WITHOUT CRUTCHES. THE STEM AND HEAD HAVE BEEN REPOSITIONED. DOI: (B)(6) 2020; DOR: (B)(6) 2020 LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 14674493 ↗
• InjuryAug 3, 2021Naturally Worn; Osseointegration Problem; Naturally Worn; Osseointegration Problem

  HIP WAS REVISED 8 YEARS POST-OP. PATIENT HAS BEEN UNHAPPY WITH IT FOR THE LAST COUPLE YEARS, SO WAS REVISED FOR STEM LOOSENING. DURING REVISION THE STEM WAS GROSSLY LOOSE AND CAME OUT BY HAND. HE FOUND THERE WAS A COATING ON THE STEM WHEN REMOVED (QUERY CERAMIC DEBRIS, MECHANICAL LOOSENING).

  Patient problems: Inadequate Osseointegration

  MAUDE report 12270541 ↗
• InjuryJul 6, 2021Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SURGEON SUSPECTED THAT THE STEM WAS UNDERSIZED AND IN A BIT VARUS, WHICH IS WHY THE STEM WAS REMOVED RELATIVELY EASILY. THE PATIENT COULD NOT COMMENT ON WHETHER THE STEM WAS ACTUALLY LOOSE, HOWEVER, THE SURGEON IMPLIED IT.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12124969 ↗