CORAIL 3L92500Recalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 10603295168669), received between Nov 13, 2017 and May 5, 2026 — classified as 90 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (16 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 95 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE-RIGHT HIP.

  Patient problems: Pain

  MAUDE report 25085686 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED THE HIP FRACTURE. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 24758583 ↗
• InjuryJan 7, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AS THE STEM WAS LOOSE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21090701 ↗
• MalfunctionNov 18, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20709198 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD 1STAGE HIP REVISION, REMOVED IMPLANTS AND PUT NEW IMPLANTS IN BECAUSE OF POSSIBLE INFECTION. THERE WAS NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 20292252 ↗
• MalfunctionAug 7, 2024Device-Device Incompatibility; Device-Device Incompatibility

  THE CORAIL STEM COULD NOT BE REMOVED FROM THE CORAIL IMPACTOR. THE IMPACTOR AND CORAIL STEM WERE FUSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19929834 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HIP WAS REVISED DUE TO SURGEON SUSPICION OF INFECTION. COMPONENTS WERE REMOVED AND ANTIBIOTIC SPACERS WERE IMPLANTED. NO OTHER INFORMATION IS KNOWN. DOI- UNKNOWN. DOR- (B)(6). 2024. AFFECTED SIDE- LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19762105 ↗
• InjuryMar 19, 2024Osseointegration Problem; Migration; Osseointegration Problem; Migration

  AFTER THE REVIEW OF MEDICAL RECORDS, OPERATIVE NOTES REPORTED PAIN. X-RAY SHOWED OBVIOUS SUBSIDENCE OF THE IMPLANT, IMPLANT LOOSENING AND INFECTION MAY ALREADY BE PRESENT. THE SURGEON WAS ABLE TO EXTERNALLY ROTATE SOME OF THE SLEEVE SCAR TISSUE. CLINIC VISITS REPORTED DISCOMFORT AND MOVEMENT IMPAIRMENT. DOI: (B)(6) 2007 DOR: (B)(6) 2022 RIGHT HIP

  Patient problems: Adhesion(s); Bone Fracture(s); Discomfort; Loss of Range of Motion; Pain; Scar Tissue; Unspecified Infection

  MAUDE report 18933899 ↗
• InjuryFeb 12, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WITH PARKINSON¿S LOST BALANCE IN SHOWER RESULTING IN A FALL AND HIP DISLOCATION AND LOOSENING HIP PROSTHETIC. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2024 DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Inadequate Osseointegration

  MAUDE report 18686334 ↗
• MalfunctionJan 22, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  WAS THE PRODUCT USED IN THE SURGERY? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18551165 ↗
• InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  J&J MD MIR SUBMISSIONS. MEDICAL AFFAIRS EMEA HAVE RECEIVED: A PATIENT RECEIVED A CORAIL PINNACLE HIP WITH CERAMIC ON CERAMIC ARTICULATION 1, 5 YEARS AGO. NOW PRESENTING INCREASED LEVELS OF COBALT, CHROME AND TITANIUM IN BLOOD. IS THERE ANY ROOT SOURCE CAUSING THIS IN CORAIL PINNACLE COMPOSITION DESCRIBED?

  Patient problems: Metal Related Pathology

  MAUDE report 18219867 ↗
• InjuryApr 17, 2023Osseointegration Problem; Osseointegration Problem

  HIP REVISION FOR FEMORAL STEM LOOSENING. DOI: (B)(6) 2008. DOR: (B)(6) 2023.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16751641 ↗
• InjuryApr 12, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration

  PATIENT PRESENTED WITH PAIN AFTER HAVING CORAIL STEM IMPLANTED ON (B)(6) 2015. AN X-RAY WAS TAKEN AND THE STEM WAS FOUND TO BE UNDERSIZED AND HAD TIPPED INTO VARUS, SURGEON REMEMBERS THE CHALLENGE DURING THIS CASE, THERE WAS A BONE ISLAND WHICH REQUIRED TO BE OVER DRILLED AT THE LEVEL OF THE LESSER TROCHANTER. THIS MAY HAVE CAUSED THE MEDULLARY CANAL TO APPEAR TIGHTER THAN IT WAS AND. RESULT IN THE SIZE 10 CORAIL STEM BEING IMPLANTED. CORAIL STEM WAS EXPLANTED USING CORAIL EXTRACTION INSTRUMENT SET. ONCE EXPOSURE WAS ACHIEVED HE USED OSTEOTOMES TO ACCESS LATERAL SHOULDER OF THE IMPLANT AND ATTACH THE EXTRACTION BOLT, AT THIS POINT THE IMPLANT WAS TOGGLING INSIDE THE FEMORAL CANAL. USING THE BACKSLAP HAMMER THE STEM WAS REMOVED. FEMUR THEN PREPARED FOR SIZE 11 CORAIL REVISION STEM, TRIAL REDUCTION PERFORMED AND DEFINITIVE IMPLANTS IMPLANTED. CUP WAS NOT REVISED. DOI: (B)(6) 2015. DOR: (B)(6) 2023. UNKNOWN HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 16723574 ↗
• InjuryMar 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND BROKE HER CALCAR. DOI- (B)(6) 2023. DOR- (B)(6) 2023. AFFECTED SIDE- LEFT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 16590618 ↗
• InjuryDec 6, 2022Osseointegration Problem; Osseointegration Problem

  REVISION OF STEM, HEAD & LINER. PERIPROSTHETIC FRACTURE & SUBSEQUENT STEM LOOSENING. ORIGINAL PRIMARY SURGERY DATE (B)(6) 2007. REVISED (B)(6) 2022. STEM REPLACED WITH RECLAIM STEM; LINER REPLACED WITH ALTRX POLY. DID THE EVENT OCCUR DURING STERILE PROCESSING? UNKNOWN. DID THE EVENT OCCUR DURING FIELD INSPECTION? UNKNOWN. DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO. IS THE PATIENT PART OF A CLINICAL STUD? NO. ACTIVITY LEVEL: ACTIVE BEFORE FALL. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. 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.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 15924393 ↗
• InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. DOI: (B)(6) 2018. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 15473825 ↗
• InjurySep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO THIGH PAIN. NO SURGICAL DELAY. DOI: (B)(6) 2019; DOR: (B)(6) 2022.

  Patient problems: Pain

  MAUDE report 15393307 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO PAINFUL LEFT HIP. DOI: (B)(6) 2020, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 15113145 ↗
• InjuryJun 27, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT SURGEON UNDERSIZED STEM AT ORIGINAL SURGERY CAUSE LOOSENING AT BONE TO IMPLANT INTERFACE. SURGEON TOOK OUT AND PUT IN REVISION STEM. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14828435 ↗
• InjuryMay 26, 2022Osseointegration Problem; Osseointegration Problem

  PATIENT FELL OVER AND SUSTAINED A PERIPROSTHETIC FRACTURE, WHICH LOOSENED HER STEM REGARDING FOR THE CORAIL STEMS REMOVAL.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 14518526 ↗
• InjuryNov 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED TO SURGERY FOR AN INFECTION. ALL IMPLANTS WERE REMOVED AND A PROSTALAC SPACER WAS PLACED. DOI: (B)(6) 2017; DOR: (B)(6) 2021: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 12846765 ↗
• InjurySep 17, 2021Osseointegration Problem; Osseointegration Problem

  COMPASS CASE (B)(4) REPORT: REVISED DUE TO INFECTED RIGHT HIP. LOOSENING COMPONENT WAS THE STEM. ALL IMPLANTS WERE REMOVED AND A TEMPORARY SPACER WAS IMPLANTED. DOR: (B)(6) 2021, DOI: (B)(6) 2016, LOOSENING INTERFACE: NON-CEMENTED.

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

  MAUDE report 12487369 ↗
• InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORTS: THE PATIENT WAS REVISED TO ADDRESS INFECTION. ALL COMPONENTS WERE EXPLANTED AND PUTTING IN A SPACER. NO SURGICAL DELAY. DOI: (B)(6) 2018; DOR: (B)(6) 2021; LEFT HIP.

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

  MAUDE report 12475256 ↗
• InjuryFeb 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAINFUL HIP. NO ADDITIONAL INFORMATION. NO SURGICAL DELAY. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT HIP.

  Patient problems: Pain

  MAUDE report 11321675 ↗
• InjuryDec 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF A CORAIL PINNACLE DUE TO INFECTION. THE CONTACT AT THE HOSPITAL TOLD ME THAT THIS PATIENT HAS HAD A REVISION IN THE PAST FOR A WASH OUT AND A HEAD AND LINER EXCHANGE. DURING THE REVISION, ALL COMPONENTS WERE REMOVED AND A CEMENTED CUP AND CEMENTED STEM WERE IMPLANTED AS A SPACER FOR THE MEANTIME. THIS PATIENT WILL BE BACK IN A FEW MONTHS ONCE THE INFECTION HAS CLEARED SO THE DEFINITIVE PROSTHESIS CAN BE IMPLANTED.

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

  MAUDE report 10942371 ↗