CORAIL 3L92510Recalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 10603295168768), received between Jun 27, 2017 and Mar 25, 2026 — classified as 94 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (17 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 98 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2026Fracture

  IT WAS REPORTED THE PATIENT INITIALLY PRESENTED VIA AMBULANCE ON (B)(6) 2026. PATIENT REPORTED SUDDEN SHARP, STABBING PAIN IN HER RIGHT HIP JOINT WHILE WALKING IN HER APARTMENT. THEREFORE, THE FRACTURE LIKELY OCCURRED ON (B)(6) 2026. THE SURGICAL REVISION AT OUR HOSPITAL TOOK PLACE ON (B)(6) 2026.

  Patient problems: Pain

  MAUDE report 24691900 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD OSTEOLYSIS IN THE LEFT HIP, WHICH NECESSITATED A REVISION PROCEDURE USING A RECLAIM APPROACH. DOI-UNKNOWN. DOR- (B)(6) 2026. AFFECTED SIDE-LEFT HIP.

  Patient problems: Osteolysis

  MAUDE report 24180360 ↗
• InjuryJan 15, 2026Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF STEM AT NON CEMENTED INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24079221 ↗
• MalfunctionMay 27, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  SURGERY IS PERFORMED NORMALLY. THE IMPLANT IS TESTED AND, ONCE THE DOCTOR DECIDES THE SIZE OF THE DEFINITIVE IMPLANT, THEY PROCEED TO OPEN AND PASS THE IMPLANT FOR PLACEMENT. HOWEVER, AFTER IMPACTING SEVERAL TIMES, THE IMPLANT DOES NOT ENTER AND BECOMES TRAPPED. SUBSEQUENTLY, THE TA PROCEEDS TO REVIEW AND REALIZES THAT THE CHARACTERISTICS OF THE IMPLANT DO NOT COINCIDE WITH THOSE OF ITS PACKAGING. THE BOX WAS CLOSED, WITH ITS PROTECTIVE PLASTIC. ONCE THE PRIMARY PACKAGING IS OPENED AND AFTER THE INCIDENT, THE PACKAGING WHERE THE STERILE STEM COMES IS CHECKED, WHICH IS WITHOUT ITS USUAL LABELS; ONLY A SMALL LABEL IS SEEN. THEREFORE, LABELS, PACKAGING AND STEM DO NOT MATCH. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF TWENTY MINUTES. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22091077 ↗
• InjuryApr 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE CORAIL STANDARD 10 BROKE POST-OPERATIVELY. THE PATIENT THEN REVISED THE DAY AFTER. THE PATIENT HAS GONE THROUGH ONE EARLIER REVISION WHERE THEY CHANGED THE HEAD.

  Patient problems: Insufficient Information

  MAUDE report 21857406 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION DUE TO PAIN. DOI: (B)(6) 2010. DOR: (B)(6) 2024. RIGHT HIP.

  Patient problems: Pain

  MAUDE report 20543733 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO PAIN. ASR REVISION. DOI: (B)(6) 2009.

  Patient problems: Pain

  MAUDE report 19629718 ↗
• InjuryJun 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD HIGH CO IONS LEVEL. PSEUDOTUMOR DUE TO METAL DEBRIS.

  Patient problems: Hypersensitivity/Allergic reaction; Metal Related Pathology

  MAUDE report 19442716 ↗
• InjuryMay 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLETE REVISION OF THA FOLLOWING PAIN.

  Patient problems: Pain

  MAUDE report 19237806 ↗
• InjuryApr 9, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE CORAIL HIGH OFFSET STEM NECK BROKE OF COMPLETELY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE : RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 19072525 ↗
• 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 18602997 ↗
• InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION COMPLAINT RECEIVED. THE PATIENT HAD A HIP REVISION DUE TO JOINT PROSTHESIS IMPLANTATION FAILURE WITH A CONDITION OF MARKED METALLOSIS AND DISLOCATION OF THE ACETABULAR POLYETHYLENE. DOI: (B)(6) 2021, DOR: (B)(6) 2023, RIGHT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 18415679 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A FALL AND EXPERIENCED A PERI PROSTHETIC FRACTURE OF THE FEMUR.

  Patient problems: Fall; Limb Fracture

  MAUDE report 18366444 ↗
• InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR XL COMPLAINT RECEIVED AD 30 NOV 2023 REASON FOR REVISION: PAIN. (B)(6). RIGHT HIP

  Patient problems: Pain

  MAUDE report 18283788 ↗
• InjuryOct 18, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED STEM LOOSENING OF THE CORAIL PINNACLE ULTAMET 1ST IMPLANTATION 2006. AFFECTED SIDE: RIGHT.

  Patient problems: Inadequate Osseointegration; Metal Related Pathology

  MAUDE report 17959506 ↗
• InjuryJul 26, 2023Use of Device Problem; Use of Device Problem

  PINNACLE MEDICAL RECORDS RECEIVED. PATIENT REPORTED METAL ON METAL RIGHT HIP WITH HIGHLY ELEVATED CHROMIUM AND NICKEL SERUM LEVELS, RETRO METALLOSIS, RETRO ACETABULAR OSTEOLYSIS, IMPINGEMENT AND CUP MALPOSITION. PATIENT IS ALLERGY TO LATEX. DOI: ON (B)(6) 2011; DOE: ON (B)(6) 2020; RIGHT HIP.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Joint Laxity; Metal Related Pathology; Osteolysis; Pain

  MAUDE report 17396719 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR CLAIM RECEIVED. THE PATIENT WAS REVISED DUE TO ALVAL, SOFT TISSUE REACTION, PAIN AND FRACTURE. DOI: (B)(6) 2009; DOR: (B)(6) 2019; AFFECTED SIDE: LEFT HIP.

  Patient problems: Bone Fracture(s); Foreign Body Reaction; Pain; Unspecified Tissue Injury

  MAUDE report 17051185 ↗
• InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION RECORD RECEIVED. LITIGATION RECORD STATED THAT ON (B)(6) 2006, PLAINTIFF HAD A METAL ON METAL PINNACLE SYSTEM IMPLANTED. ON (B)(6) 2022, PATIENT WAS FORCED TO GO SURGICAL REMOVAL OF THE DEFECTIVE PINNACLE SYSTEM OF PATIENT'S HIP AT THE HOUSTON METHODIST HOSPITAL IN HOUSTON. THE PLAINTIFF SUFFERED HEAVY METAL POISONING FROM TOXIC HEAVY METALS RESULTING INJURY AND REQUIRING SURGERY. AS A RESULT OF SURGICAL REMOVAL, PLAINTIFF SUFFERED INJURY TO HIS MUSCLE AND TISSUE AND SUFFERED ADDITIONAL SCAR TISSUE FORMATION AND EXPERIENCED SIGNIFICANT PAIN, INJURY BY METALLOSIS, METAL WEAR AND METAL POISONING. DOI: (B)(6) 2006; DOR: (B)(6) 2022; UNKNOWN AFFECTED SIDE.

  Patient problems: Adhesion(s); Foreign Body Reaction; Metal Related Pathology; Nerve Damage; Osteolysis; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 16523013 ↗
• InjuryMar 3, 2023Fracture; Osseointegration Problem; Fracture; Osseointegration Problem

  HCP IS REPORTING TO NCA/BFARM: "HIP-TEP RIGHT (B)(6) 2010 IN NEUSTADT. ALWAYS BEEN SATISFIED WITH THE HIP-TEP. SUDDEN ONSET OF PAIN, NO TRAUMA, NO TRIGGERING EVENT. IN THE X-RAY FRACTURE OF THE PROSTHESIS STEM WITH CLEAR LOOSENING IN THE PROXIMAL AREA. THEREUPON EMERGENCY PRESENTATION VIA OUR CENTRAL EMERGENCY ROOM. HIP-TEP CHANGE RIGHT ON (B)(6)2023." DOI: (B)(6) 2010. DOR: (B)(6) 2023. RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 16477504 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR XL CLAIMSUITE ALERTS COMPLAINT RECEIVED AD 6 JAN 2023. PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2008, DOR: (B)(6) 2022, RIGHT HIP.

  Patient problems: Pain

  MAUDE report 16204281 ↗
• InjuryOct 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT WAS REVISED DUE TO LEFT TOTAL HIP. THE PATIENT FELL AND HAS A PERIPROSTHETIC FRACTURE. THE SURGEON FIXED THE FRACTURE AND REVISED ALL COMPONENTS. DOI- (B)(6) 2022; DOR- (B)(6) 2022; AFFECTED SIDE- LEFT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 15614337 ↗
• InjuryOct 14, 2022Fracture; Fracture

  REVISION OF A BROKEN CORAIL HIP STEM. LEFT SIDE. FIRST REVISION WAS IN 2015 . METAL-METAL. HEAD AND LINER WERE CHANGED TO CERAMIC AND POLY. DOI: 2015, DOR: (B)(6) 2022, LEFT HIP.

  Patient problems: Pain

  MAUDE report 15605253 ↗
• InjurySep 19, 2022Fracture; Fracture

  FRACTURE OF CORAIL STEM UNKNOWN SIDE.

  Patient problems: Fall; Insufficient Information

  MAUDE report 15446233 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE TOTAL HIP ARTHROPLASTY WITH THE PINNACLE PROCOAT, THE STEM, THE HEAD AND THE ALTRX FOR THE LEFT HIP JOINT AT (B)(6) HOSPITAL IN CHINA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT VISITED (B)(6) HOSPITAL FOR DISCOMFORT. ON (B)(6) 2022, THE REVISION SURGERY WAS PERFORMED. THE SURGEON MEASURED THE CUP WITH THE CT BEFORE THE SURGERY, AND THE CUP WAS 50 DEGREES AND HAD NOT MOVED THAT FAR. ACCORDING TO THE SURGEON, THE SEQUENCE OF THE EVENT IS AS FOLLOWS. FIRST, THE LIP OF THE OFFSET LINER WAS BROKEN, AND DISLOCATION OCCURRED. NEXT, THE LINER DISLOCATED, AND THE CERAMIC HEAD SCRATCHED AND DESTROYED THE CUP. THE WOUND WAS BLACK DUE TO METALLOSIS. THE SURGEON REMOVED THE HEAD, AND THE LINER WAS TAKEN OFF EASILY. THE SURGEON REMOVED THE CUP WITH AN EXPLANT TOOL. AFTER REMOVAL, THE SURGEON INSERTED ZB¿S DUAL MOBILITY AND A HEAD. THE HEAD AND THE CUP WILL BE REPLACED WITH OTHER COMPANY¿S CUP. ACCORDING TO THE SURGEON, AFTER DESTRUCTION OF POLYETHYLENE, THE CUP WAS BROKEN BY CERAMIC HEAD. NEXT, DISLOCATION OCCURRED, AND DESTRUCTION OF BONE MATRIX FLOOR WAS SUSPECTED. SINCE THE P

  Patient problems: Discomfort; Foreign Body Reaction; Unspecified Tissue Injury

  MAUDE report 15282659 ↗
• InjuryAug 9, 2022Fracture; Fracture

  SURGEON REPORTED TO BFARM: "FRACTURE OF STEM NECK." DOI: UNKNOWN. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Insufficient Information

  MAUDE report 15191262 ↗