CORAIL L20314Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10603295258056), received between Jun 28, 2017 and Dec 2, 2025 — classified as 2 deaths, 43 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (8 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 48 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR FRACTURE. DOI- UNKNOWN. DOR- (B)(6) 2025. EFFECTED SIDE- RIGHT HIP.

  Patient problems: Bone Fracture(s)

  MAUDE report 23696889 ↗
• InjuryOct 15, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration

  PATIENT WAS REVISED DUE TO LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. CORAIL STEM SUBSIDED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23289825 ↗
• InjuryFeb 13, 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 PERI-PROSTHETIC FRACTURE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2014. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 21379413 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A FALL AND ENCOUNTERED A PERI-PROSTHETIC FRACTURE. THE PATIENT WAS REVISED TO A RECLAIM STEM. THERE WAS NO SURGICAL DELAY OTHER THAN THE TIME REQUIRED TO TAKE THE STEM OUT. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 21124069 ↗
• InjuryOct 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT INDEX CORAIL PROCEDURE WITH PINNACLE CUP ON (B)(6) 2015. THE FOLLOWING YEAR, THE PATIENT GOT HIT BY A BUS AND SUFFERED FRACTURES TO HIS ANKLE. AFTER THIS INCIDENT PATIENT HAD AN INFECTION AND HAS NEVER RESOLVED. HE HAD DECLINED A REVISION OF THE COMPONENTS AT THAT TIME BUT HAS NOW EXPERIENCED INCREASED PAIN. THE IMPLANTS WERE ALL REMOVED AND DISCARDED BY THE HOSPITAL AND TEMPORARY IMPLANTS WERE PLACED. THE PLAN IS TO PERFORM THE SECOND STAGE REVISION AT THE BEGINNING OF (B)(6) 2024.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 20385934 ↗
• InjuryFeb 6, 2024Fracture; Fracture

  ADDITIONAL INFORMATION RECEIVED STATES THAT DUE TO THE CONE FRACTURE, A LARGE CHANGE OPERATION WAS REQUIRED. ON (B)(6) 2024, A TRANSFEMORAL STEM CHANGE TO A REVISION STEM TOOK PLACE.

  Patient problems: Insufficient Information

  MAUDE report 18649964 ↗
• 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 18603056 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Bone Fracture(s)

  MAUDE report 18256431 ↗
• InjuryJan 6, 2023Osseointegration Problem; Osseointegration Problem

  REVISION TOTAL HIP DUE TO PERI PROSTHETIC FRACTURE. THE STEM WAS LOOSE DUE TO THE FRACTURE, SURGEON REMOVED STEM AND REPLACED WITH ZIMMER STEM. ON ACETABULAR SIDE HE REMOVED THE CERAMIC LINER AND REPLACED WITH A PINNACLE MDM LINER AND BIMENTUM LINER.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 16116307 ↗
• InjuryJan 3, 2023Osseointegration Problem; Osseointegration Problem

  REVISION OF LOOSE STEM.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16087505 ↗
• InjuryMar 3, 2022Osseointegration Problem; Migration; Osseointegration Problem; Migration

  REVISION COMPLETED DUE TO LOOSENING. SURGEON REPORTED A CORAIL STEM THAT BECAME LOOSE AFTER 4 YEARS. DOI: (B)(6) 2017, DOR:(B)(6) 2022.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13664714 ↗
• InjuryJan 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION DEEP VS SUPERFICIAL EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021, DATE OF EVENT (ONSET): (B)(6) 2021, (LEFT HIP). TREATMENT: SURGICAL JOINT ASPIRATION, AND SUPERFICIAL WOUND (SUPERFICIAL INFECTIONS WITH SUBCUTANEOUS INDURATION) SCRUBBED WITH CHLORHEXIDINE AND IRRIGATED WITH ANCEF IN 2 LITERS OF FLUID.

  Patient problems: Adhesion(s); Erythema; Fluid Discharge; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 13392168 ↗
• InjuryJul 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF PRIMARY THA DUE TO PERI-PROSTHETIC FRACTURE, PATIENT HAD A FALL, ORIGINAL SURGERY (B)(6) 2021, REVISED TO MUTARS STEM, ORIGINAL CUP RETAINED, BUT WITH OUR CONSTRAINED LINER.

  Patient problems: Fall; Limb Fracture

  MAUDE report 12245920 ↗
• InjuryFeb 9, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE POST OP FEMUR WAS FRACTURE. IT WAS ALSO INDICATED THAT THE STEM WAS LOOSE AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT HIP.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 11300756 ↗
• InjuryJan 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ELEVATED METAL ION LEVEL. STEM WAS WILL FIXED. FEMORAL HEAD AND LINER EXCHANGED OF SURGERY. DOI: 2011. DOR; (B)(6) 2021; RIGHT HIP.

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

  MAUDE report 11201807 ↗
• InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REMOVAL OF ALL IMPLANTS AND PLACEMENT OF ANTIBIOTIC SPACER DUE TO INFECTION. DOI: (B)(6) 2020. DOR: (B)(6) 2020; LEFT SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10828862 ↗
• InjuryAug 6, 2020Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  PT HAD CORAIL STEM REMOVED DUE TO PERI PROSTHETIC FRACTURE. ANOTHER COMPANY'S FEMORAL STEM PROSTHESIS WAS IMPLANTED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? YES, PATIENT STATUS/ OUTCOME / CONSEQUENCES? NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (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: Bone Fracture(s); Inadequate Osseointegration; No Code Available

  MAUDE report 10373157 ↗
• MalfunctionJul 29, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IMPLANT STERILE PACKAGING WAS OPEN WHEN REMOVED FROM BOX.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10339459 ↗
• InjuryMar 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGED INFECTION. PFS ALLEGED PAIN, REDNESS, AND DRAINAGE. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS LEFT INFECTED TOTAL HIP ARTHROPLASTY. UPON PHYSICAL EXAMINATION ON (B)(6) 2018, PATIENT HAS FEVER. PAIN, SWELLING, REDNESS, DRAINAGE, THROBBING FRONTAL HEADACHE, SQUEEZING CHEST PAIN, AND FATIGUE WERE ALLEGED. PATIENT SAID INCISION IS DRAINING YELLOW TO BROWN FLUID BUT DRAINAGE HAS NO ODOR. OPERATIVE NOTES INDICATED A COMMUNICATION WAS FOUND BETWEEN THE SUPERFICIAL SPACE AND DEEP TO THE FASCIA. THE SUPERFICIAL SPACE WAS DEBRIDED. AN EXCISIONAL DEBRIDEMENT OF SKIN, SUBCUTANEOUS TISSUE, FAT AND THE FASCIA WERE DONE. THE SUPERFICIAL SPACE WAS THEN COPIOUSLY IRRIGATED. THERE WAS FLUID DEEP TO THE FASCIA WITH PURULENCE ABOUT 80 CC OF PURULENT FLUID. THE CAPSULE WAS DEBULKED AND SCAR TISSUE WAS REMOVED. SCAR TISSUE WAS ALSO REMOVED AROUND THE ACETABULAR COMPONENT. A THOUROUGH DEBRIDEMENT OF AN INFECTED LOOKING TISSUE WAS DONE AROUND THE ACETABULUM AND FEMUR. AFTER ALL INFECTED LOOKING TISSUES WERE EXCISED THE HIP WAS IRRIGATED WITH 9 LITERS OF IRRIGATION AS WELL AS BETADINE IRRIGATION. BASED ON FLOUROSCOPY, THERE WAS NO IATROGENIC FRACTURES. LABORATORY RESULTS I

  Patient problems: Adhesion(s); Chest Pain; Edema; Erythema; Fatigue; Fever; Headache; No Code Available; Pain; Unspecified Infection; Wound Dehiscence

  MAUDE report 9836925 ↗
• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN. ADDITIONALLY, ELEVATED METAL ION LEVELS, PSEUDOCYST TUMOR AND METALLOSIS WERE NOTED. REVISION NOTES REPORTED TRUNNIONOSIS, MILD SYNOVIAL STAINING AND HYPERTROPHY OF SYNOVIUM. DOI: (B)(6) 2008; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; No Code Available; Pain

  MAUDE report 9813675 ↗
• InjuryFeb 13, 2020Corroded; Osseointegration Problem; Corroded; Osseointegration Problem

  PCF AND MEDICAL RECORDS. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESSED PERIPROSTHETIC OSTEOLYSIS, ACETABULAR COMPONENT LOOSENING AND ELEVATED METAL IONS. REVISION NOTES INDICATED DARK STAINED REACTIVE SYNOVIUM ENCOUNTERED AND DEBRIDED. WITH TORQUE ON THE PROSTHETIC HEAD, FEMORAL MICROMOTION WAS CONFIRMED CONSISTENT WITH THE DIAGNOSED OF LOOSENING. DISASSEMBLY OF THE MODULAR HEAD REVEALED RELATIVELY LITTLE BLACK CORROSIVE DEBRIS INSIDE THE TAPER AND THE TRUNNION APPEARED NORMAL. A LONG CURETTE WAS USED TO ENSURE REMOVAL OF ANY ENDOSTEAL CALCIFICATION POTENTIALLY DIVERTING THE FEMORAL REAMERS. THERE WAS NO SIGNIFICANT EVIDENCE OF CORROSION ON THE BACKSIDE OF THE LINER OF THE INSIDE OF THE SHELL. THE 2 ACETABULAR FIXATION SCREWS WERE REMOVED. THE CUP LOOSE WATERY REGION OF ANTERIOR RIM WAS OVERHANGING SO IT WAS USED TO REMOVE THAT RIM OF BONE AND DISLODGE THE CUP. THERE WAS A REMAINING REASONABLY HEMISPHERICAL ACETABULAR CAVITY. DOI: (B)(6) 2009; DOR: (B)(6) 2019 RIGHT HIP.

  Patient problems: Calcium Deposits/Calcification; Foreign Body Reaction; Inadequate Osseointegration; No Code Available; Osteolysis; Pain; Test Result

  MAUDE report 9707624 ↗
• InjuryJan 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PCF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESSED PAINFUL LEFT METAL ON METAL HIP REPLACEMENT AND LIMPING MORE. OPERATIVES NOTES INDICATED COPIOUS AMOUNT OF THICK DARK FLUID EXTRUDED FROM THE JOINT CONSISTENT WITH SEVERE METALLOSIS OF THE HIP. THERE IS A DEAD TISSUE AROUND POSTERIOR AND ANTERIOR PORTION. EXPOSED THE FEMORAL STEM, THERE WAS SOME EROSION OF THE BONE AROUND THE PROXIMAL PORTION OF THE STEM, THERE IS NO EVIDENCE OF LOOSENING AND NO IMPINGEMENT IN THE HIP AND FOUND TO BE STABLE. DOI: (B)(6) 2006; DOR: (B)(6) 2017; LEFT HIP.

  Patient problems: Erosion; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Necrosis; No Code Available; Pain

  MAUDE report 9653021 ↗
• InjuryDec 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9466700 ↗
• InjuryDec 12, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  PFS ALLEGED SEVERE MIGRAINE AND HEADACHE. AFTER REVIEW OF MEDICAL RECORDS, OPERATIVE NOTES INDICATED FEMORAL STEM WAS LOOSE WITH EXTENSIVE PROXIMAL OSTEOLYSIS. ADDED HEIGHT AND WEIGHT OF PATIENT. DOI: (B)(6) 2011 DOR: (B)(6) 2018 LEFT HIP.

  Patient problems: Foreign Body Reaction; Headache; Hypersensitivity/Allergic reaction; Inadequate Osseointegration; Injury; Limited Mobility Of The Implanted Joint; Osteolysis; Pain; Test Result

  MAUDE report 9457511 ↗
• InjuryOct 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS GRINDING AND PAIN. DOI: (B)(6) 2006. DOR: (B)(6) 2013, (RIGHT HIP).

  Patient problems: No Code Available; Pain; Test Result

  MAUDE report 9146877 ↗