CORAIL 3L93711Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 10603295168881), received between Aug 30, 2017 and Jul 10, 2026 — classified as 1 death, 63 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (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 69 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2026Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED PAIN. AFTER TEST, IT WAS DETERMINED THAT STEM WAS LOOSE, WHICH WAS WHY IT WAS REVISED. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 25779122 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT THE PATIENT HAD FALL RESULTING IN A FEMUR FRACTURE. THE FEMUR SINCE HEALED HOWEVER THE HIP BECAME UNSTABLE AND THEN REQUIRED REVISION. NO INFECTION NOTED. INDEX PROCEDURE CARRIED OUT.

  Patient problems: Fall; Joint Laxity; Limb Fracture

  MAUDE report 24475246 ↗
• InjuryOct 22, 2025Osseointegration Problem; Osseointegration Problem

  CORAIL STEM BECAME LOOSE. CORAIL 11 KLA COLLARED STEM WAS LOOSE. SURGEON INDICATED PATIENT HAD SEPSIS IN THE PAST AND THAT MAY BE THE CAUSE. DOI: UNKNOWN. DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Sepsis

  MAUDE report 23360675 ↗
• InjuryMay 6, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REVISED DUE TO INSTABILITY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. DOI: (B)(6) 2022, DOR: (B)(6) 2025, AFFECTED AREA: UNK HIP.

  Patient problems: Inadequate Osseointegration; Joint Laxity

  MAUDE report 21969983 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED AND THE SURGEON PULLED CONSTRUCT FOR INFECTION. THE SURGEON PUT IN PROSTALAC INSTEAD. THERE WAS NO IMPLANT FAILURE, NO LOOSENING, NO BROKEN IMPLANTS. THERE WERE NO PIECES LEFT BEHIND. THERE WAS NO SURGICAL DELAY. THERE WERE NO COMPLAINTS FROM SURGEON. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21953474 ↗
• InjuryJan 23, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO STEM LOOSENING AT NON-CEMENTED INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21223547 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED ON (B)(6) 2024 FOR PERIPROSTHETIC FRACTURE POST OP. DATE OF IMPLANT (B)(6) 2024

  Patient problems: Limb Fracture

  MAUDE report 20737654 ↗
• InjurySep 3, 2024Degraded; Degraded

  UBJECT ID: (B)(4). STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR ADVERSE TISSUE REACTION, SURGICAL SITE. DEVICE AND PROCEDURE (RELATEDNESS) DEFINITELY RELATED TO DEVICE, DEFINITELY NOT RELATED TO PROCEDURE. DATE OF EVENT: 01/JAN/2023. ADDITIONAL EVENT INFORMATION: MEDICAL RECORDS RECEIVED ON AD 23 AUGUST 2024 WERE REVIEWED BY A CLINICIAN TO IDENTIFY PATIENT HARMS/PRODUCT ISSUES. PATIENT RECEIVED A LEFT HIP REVISION OF A MOM HEAD AND LINER TO TREAT ELEVATED BLOOD METAL IONS. UPON ENTERING THE JOINT, METALLOSIS, SYNOVITIS, AND STAINED FLUID WAS EVACUATED FROM THE JOINT. THE HEAD SHOWED WEAR AND THERE WAS CORROSION ON THE HEAD/STEM TRUNNION. THE HEAD WAS REVISED AND THE CORROSION WAS CLEANED FROM THE WELL-FIXED STEM TAPER AND THE STEM WAS RETAINED. THE METAL LINER SHOWED BACKSIDE WEAR AND WAS REVISED. THE CUP WAS WELL-FIXED AND RETAINED. THE PATIENT WAS REVISED WITH A DEPUY MOC BEARING. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PLEASE NOTE: THE OPERATIVE NOTE CONFIRMS THAT THE REVISED BEARINGS ARE METAL-ON-METAL THAT WERE REPLACED WITH THE POLY LINER AND CERAMIC FEMORAL HEAD NOTED IN THE ORIGINAL EVENT DESCRIPTION. DOI: 2008. DOR: (B)(6) 2024. LEFT HIP.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Swelling/ Edema; Synovitis

  MAUDE report 20125469 ↗
• MalfunctionJul 10, 2024Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  THE PACKAGE WAS RECEIVED DAMAGED, AND THE STERILE BOX CONTAINING THE PRODUCT WAS ALSO DAMAGED.

  Patient problems: Insufficient Information

  MAUDE report 19715690 ↗
• InjuryMay 20, 2024Loss of or Failure to Bond; Osseointegration Problem; Loss of or Failure to Bond; Osseointegration Problem

  REVISION OF CORAIL/PINNACLE CONSTRUCT IMPLANTED (B)(6) 2023 BY SURGEON IN HOSPITAL. REASON FOR REVISION WAS PAIN/SUSPECTED LOOSENING OF STEM/BONE INTERFACE. THE STEM, HEAD, AND LINER WERE TAKEN OUT IN THE REVISION SURGERY. THE CUP WAS LEFT IN PLACE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 19353163 ↗
• InjuryMar 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT HIP ARTHROPLASTY IN (B)(6) 2020, FOLLOWED BY A SURGICAL REVISION DUE TO DISLOCATION WITH HEAD CHANGE IN DECEMBER. ON (B)(6) 2024, TRIPPING FALL WITH FRACTURE OF THE PROSTHESIS NECK OF THE INSERTED CORAIL HIP STEM. SURGICAL REVISION WITH STEM REPLACEMENT ON (B)(6) 2024.

  Patient problems: Fall

  MAUDE report 18902347 ↗
• InjuryFeb 27, 2024Osseointegration Problem; Osseointegration Problem

  CORAIL LOOSENING, UNKNOWN INFECTION. RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 18789762 ↗
• MalfunctionFeb 2, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE PACKAGED WAS CRUSHED UPON RECEIPT.

  Patient problems: Insufficient Information

  MAUDE report 18629007 ↗
• InjuryJul 10, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STEM REVISION DUE TO ASEPTIC MOBILIZATION. DOI: (B)(6) 2016. DOE: (B)(6) 2023. AFFECTED SIDE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17287337 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH LEG PAIN. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 14828625 ↗
• InjuryJun 6, 2022Osseointegration Problem; Osseointegration Problem

  IN (B)(6) 2021, DURING A FALSE MOVEMENT, THE PATIENT FELT A SHARP PAIN, THEN SOME SENSATIONS OF CRACKING AND GRINDING, WITH THE NEED TO WALK WITH A CANE. ON THE IMAGERY EXAMINATION, A FRACTURE OF THE HEAD THE PROSTHESIS. CT SCAN: METALLOSIS AND EARLY LOOSENING OF THE FEMORAL METAPHYSIS AND A PERICOTYLOID GRANULOMA. EXPLANTATION OF THE TOTAL HIP PROSTHESIS AND REPLACEMENT WITH A CERAMIC TOTAL HIP PROSTHESIS WITH PE CEMENT. METALLOSIS OBSERVED. DOI: (B)(6) 2004, DOR: (B)(6) 2022, RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Fall; Foreign Body Reaction; Inadequate Osseointegration; Pain

  MAUDE report 14602312 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND FRACTURED FEMUR. REVISION OF FEMORAL COMPONENTS. DOI: (B)(6) 2022; DOR: (B)(6) 2022; UNKNOWN SIDE.

  Patient problems: Fall; Limb Fracture

  MAUDE report 14252999 ↗
• InjuryApr 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 14220758 ↗
• InjuryApr 18, 2022Fracture; Fracture

  THE PATIENT WAS IMPLANTED ON 2003 WITH A COUPLE CERAMIC-CERAMIC. CHANGE OF THE COTYLE ON 2017 WITH CONSERVATION OF THE FEMORAL STEM BUT IMPLANTATION OF TRITANIUM CUP WITH POLYETHYLENE X3 AND FEMORAL HEAD 36MM. SIMPLE POST OPERATIVE. ON (B)(6) 2022 : DESCENT OF STAIRS AT HOME WITH SENSATION OF RUPTURE OF THE IMPLANT AND FALL. ON RADIOGRAPHY, FRACTURE OF THE PROSTHETIC FEMORAL NECK. INDICATION OF RECOVERY WITH STEM CHANGE.

  Patient problems: Fall

  MAUDE report 14136574 ↗
• InjuryFeb 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 13537808 ↗
• InjuryJan 6, 2022Loss of or Failure to Bond; Osseointegration Problem; Migration; Loss of or Failure to Bond; Osseointegration Problem; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, 2021, THE PATIENT UNDERWENT THE THA SURGERY. AFTER THE SURGERY, ON AN UNKNOWN DATE, THE PATIENT HAD A PAIN. ON (B)(6) 2021, THE X- RAY SHOWED THAT SINKING AND LOOSENING OF THE STEM HAD OCCURRED. THE REVISION SURGERY WILL BE SCHEDULED ON AN UNKNOWN DATE. THE SURGEON COMMENTED THAT UNTIL SIX MONTHS AFTER THE SURGERY, THE POSTOPERATIVE COURSE WAS UNEVENTFUL, SO THE REASON OF THIS EVENT WAS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 13174924 ↗
• MalfunctionSep 16, 2021Device-Device Incompatibility; Device-Device Incompatibility

  SURGEON BROACHED AN 11, THEN WHEN HE IMPLANTED THE 11 STEM IT SAT UP SIGNIFICANTLY, THE STEM WAS REMOVED AND ANOTHER 11 WAS OPENED AND IT SAT APPROPRIATELY. SURGEON BELIEVES THERE WAS AN ISSUE WITH THE STEM AND WOULD LIKE IT ANALYZED. CASE WAS DELAYED 10 MIN AS THE STEM WAS REMOVED AND A NEW STEM WAS OPENED AND IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 12481060 ↗
• InjuryJul 20, 2021Adverse 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 PAIN. DOI: (B)(6) 2018: DOR: (B)(6) 2021: LEFT HIP.

  Patient problems: Pain

  MAUDE report 12195907 ↗
• InjuryFeb 24, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS PROXIMAL LOOSENING OF THE CORAIL STEM AT THE BONE TO IMPLANT INTERFACE. AN ETO WAS PERFORMED TO REMOVE THE STEM AND A REVISION STEM WAS IMPLANTED. DOI: (B)(6) 2018 - DOR: (B)(6) 2021 (LEFT HIP).

  Patient problems: Inadequate Osseointegration

  MAUDE report 11373383 ↗
• InjuryFeb 4, 2021Degraded; Degraded

  INITIAL REPORT FROM STUDY: CLINICAL ADVERSE EVENT RECEIVED FOR LINER FAILURE - WEAR AND METALLOSIS, ALVAL, KIPPEL TRENAUNAY SYNDROME. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2009, DATE OF EVENT: (B)(6) 2019, DATE OF REVISION: (B)(6) 2020, (RIGHT HIP). REVISION OF METAL HEAD AND LINER. ADDITIONAL INFORMATION RECEIVED WITH FOLLOWING INFORMATION: REVISION OPERATIVE NOTES (B)(6) 2020 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL HIP REVISION DUE TO RIGHT HIP PAIN, ADVERSE LOCAL TISSUE REACTION, POLY LINER WEAR AND OSTEOLYSIS OF PROXIMAL FEMUR AND ACETABULUM. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. UPON ENTERING THE JOINT A MASSIVE PSEUDOTUMOR WAS ENCOUNTERED ALONG WITH OSTEOLYSIS. CORROSION WAS NOTED ON THE FEMORAL STEM TRUNNION, POLYWEAR WAS NOTED ON THE LINER. BLOOD LOSS OF 1,000ML WAS NOTED, CELL SAVER WAS UTILIZED AND RETURNED 400ML OF THE PATIENTS OWN BLOOD BACK TO THEM.

  Patient problems: Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Pain

  MAUDE report 11278303 ↗