CORAIL 3L92509Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 10603295168751), received between Jul 20, 2017 and May 4, 2026 — classified as 1 death, 64 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (15 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 67 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT NEEDED MORE STABILITY. DOI: (B)(6) 2019. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 25072814 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PERI PROSTHETIC FRACTURE WAS FIXED WITH CORAIL REVISION STEM. DOI: (B)(6) 2015. DOR: (B)(6) 2025. AFFECTED AREA: HIP RIGHT.

  Patient problems: Limb Fracture

  MAUDE report 22311749 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PERI PROSTHETIC FRACTURE WITH A TROCH PLATE, CABLES, SCREWS AND RECLAIM STEM. DOI: (B)(6) 2017. DOR: (B)(6) 2025 . AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 22306775 ↗
• InjuryJan 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT PATIENT FELL AND EXPERIENCED PAIN AND IMMOBILIZATION. AS A RESULT OF A FALL, AN IMPLANTED COLLARLESS CORAIL STEM BROKE CLEANLY IN TWO FROM THE NECK IN-SITU AND WAS REMOVED FROM THE HIP DURING A REVISION.

  Patient problems: Fall; Pain

  MAUDE report 21217685 ↗
• InjurySep 5, 2024Fracture; Fracture

  ADDITIONAL INFORMATION WAS RECEIVED: WAS THERE ANY ALLEGATION AGAINST THE FOLLOWING PRODUCTS? *EA DELTA CER INSERT 36IDX52OD(121881752/3154695) *DELTA CER HEAD 12/14 36MM +12 (136536340/3163434) ? REVISION HAS SHOWED PRESENCE OF SOME CERAMIC FRAGMENT OF THE FIRST REVISED CERAMIC INSERT.

  Patient problems: Insufficient Information

  MAUDE report 20148024 ↗
• 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 18602999 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR XL CLAIMSUITE NOTIFICATION RECEIVED. THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2008. DOR: (B)(6) 2023. RIGHT HIP.

  Patient problems: Pain

  MAUDE report 18096548 ↗
• InjuryOct 2, 2023Osseointegration Problem; Osseointegration Problem

  REVISION LEFT TOTAL HIP REPLACEMENT FOR FEMORAL LOOSENING. LOOSE FEMORAL COMPONENT, BEARING ARTICULATION WAS A METAL ON METAL PINNACLE. THE CORAIL FEMORAL COMPONENT WAS LOOSE AND WAS REMOVED WITHOUT INCIDENT. THE PROSTHESIS BOTH ACETABULAR AND FEMORAL COMPONENTS WERE STAINED WITH BLACK DEBRIS AND THE SOFT TISSUE AND BONE INCLUDING THE FEMORAL CANAL WAS ALSO STAINED WITH BLACK DISCOLORED DEBRIS. ALL COMPONENTS WERE EXPLANTED EXCEPT FOR THE PINNACLE 52MM ACETABULAR 100 SERIES DUOFIX CUP. ALL EXPLANTED IMPLANTS WERE DISPOSED OF. DOI: (B)(6) 2008. DOE: (B)(6) 2023. AFFECTED SIDE: RIGHT.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration

  MAUDE report 17851092 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED HIP. SURGEON EXPLANTED ALL COMPONENTS. DEPUY PARTS WERE ONLY THE STEM. PATIENT HAD A STRYKER CUP. DOI: (B)(6) 2015, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16784045 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF ACETABULAR COMPONENTS OF A HIP-TEP. DOI: UNKNOWN, DOR: (B)(6) 2022, UNKNOWN SIDE.

  Patient problems: Pain

  MAUDE report 15587717 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLAIM SUITE ALERS AND RCF RECEIVED. CLAIM SUITE ALLEGED PAIN AS THE REASON FOR REVISION. RCF ALLEGED ELEVATED METAL IONS LEVEL, DOI: (B)(6) 2008. DOR: (B)(6) 2022 . LEFT HIP.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 15293404 ↗
• InjuryJun 8, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED AS REMOVED LOOSE STEM AND HEAD AND REPLACED WITH A NEW STEM AND HEAD. THERE WAS LOOSENING OF THE STEM. LOOSENING INTERFACE IS UNCEMENTED. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14631529 ↗
• InjuryMar 8, 2022Osseointegration Problem; Osseointegration Problem

  REVISION COMPLETED DUE TO ASEPTIC LOOSENING.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 13689715 ↗
• InjuryFeb 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR XL EMAIL NOTIFICATION RECEIVED FROM CLAIMSUITE. REASON FOR REVISION: PAIN. DOI: (B)(6) 2007, DOR: (B)(6) 2022, RIGHT HIP.

  Patient problems: Pain

  MAUDE report 13584090 ↗
• InjuryNov 29, 2021Degraded; Degraded

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY AND THE AFFECTED SIDE INVOLVED IN THIS EVENT WAS THE RIGHT HIP.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Pain

  MAUDE report 12882522 ↗
• InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR XL CLAIMSUITE ALERTS RECEIVED. RECORDS ALLEGED PAIN. RECORDS ALLEGED ELEVATED CHROMIUM LEVEL OF 13.34. DOI: (B)(6) 2006 DOR: (B)(6) 2021 LEFT HIP.

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

  MAUDE report 12495367 ↗
• InjuryJun 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR XL REVISION. CLAIMSUITE ALERTS RECEIVED. REASON FOR REVISION: PAIN RECORDS ALLEGES ELEVATED COBALT LEVEL, OSTEOLYTIC LESIONS AND OVERLYING TUMOR. DOI: (B)(6) 2007 DOR: (B)(6) 2021 RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hypersensitivity/Allergic reaction; Osteolysis; Pain

  MAUDE report 11983372 ↗
• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR REVISION: ASR XL, LEFT HIP. REASON FOR REVISION: UNKNOWN. DOI: (B)(6) 2008; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hypersensitivity/Allergic reaction; Pain

  MAUDE report 11825758 ↗
• InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CLAIMS THAT HE HAD AN ASR XL RIGHT HIP REVISION TO TREAT SEVERE PAIN. DOI: (B)(6) 2009; DOR: (B)(6) 2014; RIGHT HIP.

  Patient problems: Pain

  MAUDE report 11588394 ↗
• MalfunctionAug 4, 2020Fracture; Fracture

  PATIENT HAD HIP SURGERY MANY YEARS AGO IN DIFFERENT HOSPITAL. HYBRIDE CONSTRUCT , LATER REVISED TOT CEMENTLESS CONSTRUCT( CEMENTED CUP REPLACED) EARLIER THIS YEAR PATIENT CAME BACK WITH PAIN IN HIP AND X-RAY SHOWED OSTEOLYSIS PROXIMALY AROUND HIP PROTHESIS. PATIENT CAM TO THE HOSPITAL WITH PAIN. NO DELAY.

  Patient problems: No Code Available; Osteolysis; Pain

  MAUDE report 10362321 ↗
• InjuryMar 25, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS PRESENCE OF SMALL INFECTION. IT WAS ALSO REPORTED THAT THE STEM WAS LOOSE AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2019. DOR: (B)(6) 2020. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available; Unspecified Infection

  MAUDE report 9880316 ↗
• InjuryJan 27, 2020Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  IT WAS REPORTED THAT THERE WAS OSTEOLYSIS AROUND STEM AND CUP, PERIPROSTHETIC FEMUR FRACTURE AND LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2007; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; No Code Available; Osteolysis

  MAUDE report 9632620 ↗
• InjuryDec 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED HER PRIMARY TOTAL HIP IN 2017. REVISED TODAY DUE TO THE PATIENT BEING UNHAPPY WITH A LEG LENGTH DISCREPANCY. PAIN, IRRITATION WITH LEG LENGTH DISCREPANCY.

  Patient problems: Joint Disorder; Pain

  MAUDE report 9490513 ↗
• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR INDEX PROCEDURE. ASR XL. RIGHT HIP. REASON FOR COMPLAINT: HIGH BLOOD COBALT AND CHROMIUM LEVELS. DOI: UNKNOWN. DOR: UNKNOWN.

  Patient problems: Pain; Test Result

  MAUDE report 9377697 ↗
• InjuryNov 22, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT HAD A FEMORAL REVISION FOR A LOOSE CORAIL STEM. THE PATIENT HAD AN ULTIMET METAL LINER WHICH WAS EXCHANGED TO A 32 MM POLY LIPPED LINER. THE STEM CAME OUT WITH VERY EFFORT. THERE DID NOT APPEAR TO BE EVIDENCE OF INFECTION. THE FEMUR WITH A POROCOAT SUMMIT WAS REPLACED AND IT WORKED PERFECTLY. LOOSENING OF THE FEMORAL COMPONENT AT BONE TO IMPLANT INTERFACE. DOI: 2008; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9365063 ↗