CORAIL L20311Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 10603295258025), received between Jun 27, 2017 and Sep 2, 2026 — classified as 79 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (18 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 82 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Limb Fracture

  MAUDE report 50563793 ↗
• InjuryDec 18, 2025Degraded; Degraded

  IT WAS REPORTED THAT CORAIL2 NON COL HO SIZE 11, PINN SECTOR W/GRIPTION 54MM, UNKNOWN HIP FEMORAL HEAD, AND UNKNOWN HIP ACETABULAR LINERS WERE INVOLVED IN A REPORTED EVENT FOLLOWING AN ORTHOPEDIC PROCEDURE. THE EVENT WAS ASSOCIATED WITH METALLOSIS IN THE RIGHT HIP, WHICH IS GENERALLY LINKED TO METAL-ON-METAL PROSTHETIC DEVICES DUE TO INTERACTION BETWEEN ARTICULATING SURFACES. THE PATIENT REQUIRED A REVISION PROCEDURE DUE TO METALLOSIS, AND A FOREIGN BODY REACTION WAS NOTED.

  Patient problems: Foreign Body Reaction

  MAUDE report 23840557 ↗
• InjuryDec 5, 2025Fracture; Fracture

  HCP IS REPORTING TO BFARM/NCA: WHEN PATIENT STAND BY HIS WALKER HE FELT A CRACKING SOUND, AND THEN FELL. RADIOLOGICAL EXAMINATION REVEALED A TAPER FRACTURE OF THE IMPLANTED HIP PROSTHESIS STEM. INITIAL HIP REPLACEMENT, LEFT: (B)(6) 2010. HEAD/INLAY REPLACEMENT DUE TO INFECTION: (B)(6) 2020. REPEAT HEAD/INLAY REPLACEMENT DUE TO WEAR: (B)(6) 2024. CURRENT: STEM REPLACEMENT DUE TO CONE FRACTURE: (B)(6) 2025. THERE IS NO INDICATION THAT DEPUY-PRODUCTS WERE REVISED IN 2020 AND 2024.

  Patient problems: Fall

  MAUDE report 23728943 ↗
• InjuryFeb 25, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENTS ORIGINAL THA WAS COMPLETED ON OCTOBER 1, 2012. PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2025 DUE TO STEM LOOSENING (CORAIL KHO SZ 11 STEM, COLLARLESS). THE PATIENT THINKS IT MAY BE CAUSED BY AN INJURY THEY HAD BUT THE SURGEON WASN'T CERTAIN THIS WAS THE REASON. WHEN THE STEM WAS REMOVED THERE WAS NO BONY INGROWTH AND NO HA COATING SEEN TO BE LEFT PRESENT. A MEMBRANE OF EXTRA TISSUE HAD FORMED AROUND THE STEM WHICH THE SURGEON THOUGHT WAS DUE TO THE MOVEMENT OF THE STEM. THE LINER WAS EXCHANGED BECAUSE IT HAD BEEN IN FOR 12 YEARS AND THEY DECIDED IT WAS WORTH REPLACING WHILE ALREADY IN THERE. THOUGH IT WAS NOTED AFTER REMOVAL THAT THERE WAS YELLOWING OF THE LINER. THE LINER WAS REPLACED WITH ANOTHER PINNACLE NEUTRAL LINER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21462269 ↗
• InjuryFeb 20, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO DELAY TO SURGERY AND NO ALLEGATION AGAINST THE HEAD. IT WAS A FRACTURE FROM FALLING OVER.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 21420211 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVISION DUE TO CONTINUING PAIN IN THE REGION OF THE RIGHT GROIN. AN ULTRASOUND HAS BEEN OBTAINED AND SHOWED A FLUID COLLECTION WHICH APPEARS TO BE FILLED WITH DEBRIS. THE PATIENT ALSO DEMONSTRATED SIGNIFICANT ELEVATED COBALT AND CHROMIUM LEVELS. OPERATION PERFORMED WAS RIGHT TOTAL HIP ARTHROPLASTY WITH HEAD AND LINER EXCHANGE. DOI: (B)(6) 2009 DOR: (B)(6) 2012 AFFECTED HIP: RIGHT.

  Patient problems: Metal Related Pathology; Pain; Swelling/ Edema

  MAUDE report 19634483 ↗
• InjuryJun 11, 2024Osseointegration Problem; Osseointegration Problem

  STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR ASEPTIC LOOSENING OF THE LEFT FEMORAL COMPONENT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2018 DATE OF REVISION:(B)(6) 2024 DATE OF EVENT: 08 MAY 2024 (LEFT HIP) . TREATMENT: REVISION; LINER, STEM AND HEAD WERE REVISED.

  Patient problems: Discomfort; Inadequate Osseointegration; Pain; Swelling/ Edema

  MAUDE report 19512292 ↗
• InjuryMay 22, 2024Osseointegration Problem; Osseointegration Problem

  SUBJECT ID: (B)(4). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR ASEPTIC LOOSENING OF THE LEFT FEMORAL COMPONENT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(4) 2018. DATE OF REVISION: UNK. DATE OF EVENT: (B)(4) 2024. (LEFT HIP). TREATMENT: REVISION; STEM ,HEAD, AND LINER WERE REVISED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19374625 ↗
• 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 18603027 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING PAIN AND STRESS SHIELDING, THE THA WAS REVISED.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 18307681 ↗
• InjuryOct 30, 2023Osseointegration Problem; Osseointegration Problem

  CORAIL STEM LOOSENING: RIGHT SIDE. FIRST IMPLANT DATE: 2010. DOR: (B)(6) 2023.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18030944 ↗
• InjuryAug 31, 2023Osseointegration Problem; Osseointegration Problem

  HIP REVISION WITH CERAMIC HEAD AND METAL INSERT PROXIMAL STEM LOOSENING. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES, 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, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17661892 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION TOTAL HIP REPLACEMENT FOR INSTABILITY DISLOCATION. PRIMARY PROCEDURE BELIEVED TO PRE 2010 AT HOSPITAL. DATE UNKNOWN AND CANNOT BE SOURCED. REVISION TOTAL HIP REPLACEMENT IN 2012 (APPROXIMATE YEAR DATE UNKNOWN AND CANNOT BE SOURCED) HOSPITAL FOR MID SHAFT FEMORAL FRACTURE ALSO (PERI PROSTHETIC FRACTURE). NO COMPONENTS BELIEVE TO HAVE BEEN CHANGED DUE TO REPAIR OF THE FRACTURED FEMUR WHICH WAS REPAIRED USING A LONG BONE PLATE AND SCREWS.

  Patient problems: Joint Laxity; Limb Fracture

  MAUDE report 17169983 ↗
• InjurySep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR BLOOD CLOT IN RIGHT CALF. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2020. DATE OF EVENT: (B)(6) 2022. (RIGHT HIP). TREATMENT: UNSPECIFIED MEDICAL INTERVENTION/MODIFICATION.

  Patient problems: Embolism/Embolus

  MAUDE report 15484731 ↗
• InjuryJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FEMUR BROKE. PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? PAIN, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES, IF YES, DESCRIBE --> HIP REVISION, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4), DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE.

  Patient problems: Limb Fracture; Pain

  MAUDE report 15043020 ↗
• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INTRA-OP PERIPROSTHETIC FRACTURE - FEMORAL. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022; DATE OF EVENT: (B)(6) 2022; (RIGHT HIP). TREATMENT: INTRA-OP OPEN REDUCTION INTERNAL FIXATION.

  Patient problems: Limb Fracture

  MAUDE report 14487603 ↗
• InjuryMay 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PERIPROSTHETIC CALCAR FRACTURE - FEMORAL (INTRAOPERATIVE). EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2022. DATE OF EVENT (ONSET): (B)(6) 2022. AFFECTED SIDE: (RIGHT HIP). TREATMENT: OPEN REDUCTION INTERNAL FIXATION.

  Patient problems: Limb Fracture

  MAUDE report 14399687 ↗
• InjuryApr 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: UNKNOWN HIP AFFECTED.

  Patient problems: Unspecified Infection

  MAUDE report 14137351 ↗
• InjuryMar 17, 2022Loss of or Failure to Bond; Use of Device Problem; Osseointegration Problem; Loss of or Failure to Bond; Use of Device Problem; Osseointegration Problem

  SURGEON REVISED CORAIL PINNACLE WITH WELL FIXED CUP ON THE PATIENTS RIGHT SIDE FOR STEM LOOSENING AND MALPOSITION AFTER 9 YEARS. THE CUP WAS RETAINED AND ALL OTHER COMPONENTS REVISED. PLAN A WAS A SAS B PINNACLE DUAL MOBILITY CUP WITH CORAIL PINNALCE, OR CORAIL REVISION. SURGEON CHANGED HIS MIND AND IMPLANTED AN S-ROM HIP WITH SAS B PINNACLE DUAL MOBILITY LINER AND BEARING, OFF LABEL USAGE. FOLLOWED UP WITH AU MARKETING AND THIS COMPLAINT RAISED. SURGEON DID NOT HAVE ANY CONCERNS POST FOLLOW UP AS REQUIRED A DUAL MOBILITY DUE TO CHASING OFFSET, PLAN B FOR THE CUP WOULD HAVE BEEN A STRYKER MDM COMPONENT WHICH WOULD HAVE BEEN OFF LABEL USAGE. DOI: UNKNOWN. DOR: UNKNOWN. UNKNOWN HIP.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 13800904 ↗
• InjuryJan 18, 2022Osseointegration Problem; Osseointegration Problem

  SURGEON IS REPORTING A PLANNED REVISION OF CORAIL STEM UNKNOWN SIDE BECAUSE OF LOOSENING. THERE WAS NO SURGICAL DELAY. DOI: 2013 IN ANOTHER HOSPITAL. DOR (PLANNED): (B)(6) 2021, RIGHT SIDE. A COMPETITOR STEM WILL BE IMPLANTED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13279136 ↗
• MalfunctionDec 28, 2021Device-Device Incompatibility; Device-Device Incompatibility

  AFFECTED SIDE: RIGHT SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13093102 ↗
• InjuryDec 1, 2021Osseointegration Problem; Osseointegration Problem

  SURGEON WAS REVISING A CORAIL KHO 11 ON THE (B)(6) 2021 AND SEND THE SALES REP A COMPLAINT LETTER. THE SHAFT WAS IMPLANTED 11 YEARS AGO AND NEVER INTEGRATED. WHEN SURGEON REVISED IT, HE FOUND THE SHAFT WITH NO HYDROXY APATITE AND A NEARLY BLANK SHAFT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12908710 ↗
• InjuryNov 23, 2021Osseointegration Problem; Osseointegration Problem

  CHANGE OF A CORAIL HIP STEM (DUE TO LOOSENING. AFFECTED SIDE: RIGHT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12860542 ↗
• InjuryNov 2, 2021Migration; Migration

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL HIP TO ADDRESS PERIPROSTHETIC FEMUR BONE FRACTURE ON (B)(6) 2021, RIGHT HIP WAS REPLACED TO ADDRESS END-STAGE PRIMARY ARTHRITIS, WITH REPORTED PAIN, AND DIFFICULTIES IN AMBULATING AND PERFORMING ACTIVITIES OF DAILY LIVING. INGROWTH CUP AND STEM COMPONENTS WERE IMPLANTED USING A DIRECT ANTERIOR APPROACH. THERE WERE NO REPORTED INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2021, THE PATIENT EXPERIENCED A PERIPROSTHETIC FEMUR FRACTURE, ALLEGEDLY RESULTING FROM HAVING BECOME TANGLED IN HER CLOTHES, LOSING HER BALANCE, AND SUBSEQUENTLY FALLING TO THE FLOOR. SHE WAS FOUND TO HAVE A DISPLACED FEMUR FRACTURE WITH FEMORAL STEM SUBSIDENCE, WHICH REQUIRED EMERGENT OPEN REDUCTION INTERNAL FIXATION OF HER FEMUR. THE HIP WAS REVISED, WITH PLACEMENT OF A RECLAIM FEMORAL STEM, AND REDUCED WITH FIXATION REINFORCED WITH PLACEMENT OF AN ALLOGRAFT FEMORAL STRUT SPLINT WITH FOUR SYNTHES CERCLAGE CABLES. ON (B)(6) 2021, THE PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY TO ADDRESS PRIMARY ARTHRITIS, END-STAGE, RIGHT HIP. DEPUY COMPONENTS, INCLUDING TWO DOME SCREWS WERE USED DURING THIS PROCEDURE. ON (B)(6) 2021, THE PATIENT HAD A REVISION RIGHT TOTAL HIP

  Patient problems: Fall; Limb Fracture

  MAUDE report 12737699 ↗
• InjuryOct 25, 2021Fracture; Fracture

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE AFFECTED SIDE OF THE PATIENT WAS THE RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 12689299 ↗