CORAIL 3L92515Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295168812), received between Dec 5, 2017 and Dec 1, 2025 — classified as 18 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryDec 1, 2025Fracture; Fracture

  ADDITIONAL INFORMATION RECEIVED STATES THAT "ON 07.11.2025. WHILE THE PATIENT WAS IN PODGORICA, MONTENEGRO AND WAS WALKING DOWN THE STREET IN THE USUAL WALK, WITHOUT ANY EXTERNAL CAUSE, TRAUMA OR UNUSUAL PHYSICAL STRAIN, THERE WAS A SUDDEN AND COMPLETE FRACTURE OF THE RIGHT HIP ENDOPROSTHESIS, WHICH THE PATIENT FELL TO PAVEMENT, WHICH REQUIRED URGENT MEDICAL INTERVENTION AND HOSPITALIZATION. THE PATIENT WAS THEN TRANSPORTED TO (B)(6), SERBIA WHERE HE WAS REOPERATED ON (B)(6) 2025. BY THE SAME DOCTOR WHO PERFORMED THE INITIAL OPERATION, THE BROKEN ENDOPROSTHESIS WAS REMOVED AND REPLACED BY A NEW ONE. THE PATIENT IS CURRENTLY IN THE POSTOPERATIVE RECOVERY PHASE. PLEASE NOTE THAT, IN ORDER TO FULLY CLARIFY THE CIRCUMSTANCES OF THIS EVENT, COMPLETE MEDICAL DOCUMENTATION AND POST-OPERATIVE RADIOLOGICAL RECORDINGS WERE ANALYZED AFTER THE FIRST OPERATION, WITH NO ELEMENTS WERE IDENTIFIED INDICATING A FAULT IN SURGICAL PROCEDURE OR IMPROPER IMPLANTATION OF ENDOPROSTHESIS."

  Patient problems: Fall; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23682571 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION THAT HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED: A1, A2, A3A, B3, B5, D4 (LOT, CATALOG, EXPIRATION DATE), G4 PMA/510(K), H4. CORRECTED: D1, D2B, D3, D4 PRIMARY UDI NUMBER. IF INFORMATION THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT IS OBTAINED, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

  Patient problems: Limb Fracture

  MAUDE report 21662113 ↗
• InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED REVISION OCCURRED ON (B)(6) 2024 DUE TO THERE WERE HIGH CO LEVELS AND ILIOFEMORAL PSEUDOTUMOR 10X8X8. NO SURGICAL DELAY REPORTED. ORIGINAL IMPLANT DATE (B)(6) 2006.

  Patient problems: Hypersensitivity/Allergic reaction; Metal Related Pathology

  MAUDE report 20611473 ↗
• 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 18602989 ↗
• MalfunctionJan 16, 2024Expiration Date Error; Expiration Date Error

  ADDITIONAL INFORMATION RECEIVED: 1. WHAT WAS THE REASON FOR THE SURGERY? - PROXIMAL FEMUR FRACTURE 2. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? -NO 3. WAS THERE ANY PATIENT HARM RELEVANT TO THIS EVENT? IF YES, PLEASE KINDLY PROVIDE DETAILS. -NO 4. DID THIS EVENT HAPPENED DURING PRIMARY SURGERY OR REVISION SURGERY? -PRIMARY SURGERY. HEMI ARTHROPLASTY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18517215 ↗
• InjuryJun 8, 2022Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF STEM AFTER A FALL. STEM AND HEAD WAS REMOVED AND REPLACED THE HEAD AND STEM. CEMENT INTERFACE WAS NON-CEMENTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2017. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Inadequate Osseointegration

  MAUDE report 14630788 ↗
• InjuryOct 15, 2020Naturally Worn; Naturally Worn

  ASR MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS PAIN AND MILD ELEVATED METAL IONS. OPERATIVE NOTE REPORTED A BLACK TRUNNION AND EVIDENCE OF WEAR ON THE TRUNNION AND SOME IMPINGEMENT SEE ON NECK. DOI: (B)(6) 2006; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available; Pain; Test Result

  MAUDE report 10682663 ↗
• InjurySep 14, 2020Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A PRIMARY HIP REPLACEMENT (LEFT SIDE) IN THE (B)(6) APPROXIMATELY 10 YEARS AGO. PATIENT COMPLAINING OF THIGH PAIN FOR THE LAST YEAR. UNDERWENT REVISION SURGERY FOR A SUSPECTED LOOSE STEM.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 10528186 ↗
• InjuryDec 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION PAPERS ALLEGE THE PATIENT SUFFERED EXTREME PAIN, DISCOMFORT, SORENESS, MALAISE, SWELLING, LOSS OF ENERGY, IMMOBILIZATION, BOTH ACUTE LOCALIZED DAMAGE TO TISSUE AND/OR BONE SURROUNDING THE ACETABULUM AND SYSTEMIC INJURIES. PAPERS ALSO ALLEGE EXCESSIVE LEVELS OF CHROMIUM AND COBALT BLOOD LEVELS. DOI: (B)(6) 2009, DOR: NONE SCHEDULED AT THIS TIME (LEFT SIDE); DOI: (B)(6) 2009, DOR: NONE SCHEDULED AT THIS TIME (RIGHT SIDE); DOI: (B)(6) 2009, DOR: NONE REPORTED (LEFT HIP). SEE BILATERAL: (B)(4) RIGHT HIP.

  Patient problems: Discomfort; Foreign Body Reaction; Injury; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Swelling; Test Result

  MAUDE report 9469058 ↗
• InjuryOct 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS ALLEGES LIMITED RANGE OF MOTION AND WEAKNESS. PPF ALLEGES INFECTION. AFTER REVIEW OF MEDICAL RECORDS, IT WAS INDICATED THAT THE PATIENT WAS REVISED FOR FAILED LEFT THA SECONDARY TO INFECTION AND A STAGE 1 OF 2 REVISION WAS PERFORMED. OPERATIVE NOTES AND DATE OF SURGERY WERE NOT PROVIDED. DOI: (B)(6) 2008 (CUP AND STEM), DOI: (B)(6) 2010 (HEAD AND LINER), DOR: UNKNOWN (1ST STAGE REVISION), LEFT HIP.

  Patient problems: Fatigue; Loss of Range of Motion; No Code Available; Unspecified Infection

  MAUDE report 9139711 ↗
• InjuryApr 29, 2019Loss of Osseointegration; Biocompatibility; Loss of Osseointegration; Biocompatibility

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL ION PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. UPDATE PPF ALLEGES LOOSENING OF STEM, AND ELEVATED METAL IONS. DOI: (B)(6) 2010 - DOR: (B)(6) 2012 (LEFT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; No Code Available; Pain; Test Result

  MAUDE report 8559938 ↗
• InjuryApr 29, 2019Loss of Osseointegration; Biocompatibility; Osseointegration Problem; Loss of Osseointegration; Biocompatibility; Osseointegration Problem

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL ION PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. PPF ALLEGES LOOSENING OF STEM. DOI: (B)(6) 2009 - DOR: (B)(6) 2013, (RIGHT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; No Code Available; Pain; Test Result

  MAUDE report 8559929 ↗
• InjuryApr 25, 2019Loss of Osseointegration; Loss of Osseointegration

  REVISION OF RIGHT HIP REPLACEMENT DUE TO LOOSENING, BEARING SURFACE WAS CERAMIC HEAD ON METAL LINER.

  Patient problems: Inadequate Osseointegration; No Code Available; Tissue Damage

  MAUDE report 8551881 ↗
• InjuryApr 17, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE HIP STEM WAS PUT IN "EXTREME EXTERNAL ROTATION" PER SURGEON. THE ACETABULAR COMPONENT WAS PUT IN WITH 60+ DEGREES OF ABDUCTION. ALL COMPONENTS WERE REVISED. DOI: UNKNOWN; DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 8522876 ↗
• InjuryFeb 14, 2019Loss of Osseointegration; Biocompatibility; Osseointegration Problem; Loss of Osseointegration; Biocompatibility; Osseointegration Problem

  LITIGATION ALLEGES PATIENT SUFFERS FROM SEVERE PAIN, DISCOMFORT, AND INFLAMMATION. LITIGATION ALSO ALLEGES LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE PLAINTIFF'S BLOOD, TISSUE, AND BONE. UPDATE: 7/3/2013 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED BY INVOICE SEARCH. UPDATE AD 20 JUN 2018 RECEIPT OF PPF AND STICKER SHEETS RECORD. IN ADDITION TO PREVIOUS ALLEGATIONS, PPF ALLEGES LOOSENING OF STEM AND METALLOSIS.

  Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; No Code Available; Pain; Test Result; Tissue Damage

  MAUDE report 8338693 ↗
• InjuryJan 10, 2019Migration; Migration

  IT WAS REPORTED THAT PATIENTS STEM HAD SUBSIDED CAUSING INSTABILITY ISSUES. DOI: (B)(6) 2018. DOR: (B)(6) 2018. RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 8235310 ↗
• InjuryAug 30, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT. LITIGATION ALLEGES SEVERE PAIN, DISCOMFORT, INFLAMMATION, AND ELEVATED LEVELS OF COBALT CHROMIUM METAL IONS AND PARTICLES IN THE BLOOD AND TISSUE SURROUNDING THE IMPLANT. LITIGATION ALSO ALLEGES THAT THE PATIENT SUFFERS FROM A 'POPPING' IN THE RIGHT HIP. BILATERAL: DOI: (B)(6) 2007 - DOR: NONE REPORTED (RIGHT SIDE); DOI: (B)(6) 2008 - DOR: NONE REPORTED (LEFT SIDE). PATIENT IS A RESIDENT OF (B)(6). UPDATE: 11/2/2012 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. PATIENT DEMOGRAPHICS ADDED. UPDATE AD 24 APRIL 2018: (B)(4) HAS BEEN REOPENED UNDER (B)(4) DUE TO RECEIPT OF PPF AND STICKER SHEETS. THERE WAS NO NEW INFORMATION FOUND IN THE PPF. HOWEVER, ADDED THE STEM TO THE IMPACTED PRODUCTS TO ADDRESSED THE PREVIOUS ALLEGATION OF ELEVATED LEVELS OF COBALT, CHROMIUM METAL IONS. DOI: (B)(6) 2007; DOR: NONE REPORTED; (RIGHT SIDE).

  Patient problems: Discomfort; Inflammation; No Code Available; Pain; Test Result

  MAUDE report 7832675 ↗
• InjuryMay 3, 2018Loss of Osseointegration; Loss of Osseointegration

  REVISION: LOOSENING OF THE FEMORAL STEM, PAIN (B)(6) 2018, DR (B)(6). PATIENT UNDERWENT PRI (B)(6) ON (B)(6) 2008 - (DR (B)(6), (B)(6) HOSPITAL (B)(6)). PATIENT HAS PRESENTED WITH PAIN? X RAYS INDICATE A LOOSE FEMORAL COMPONENT. ON OPENING THE HIP THE CORAIL STEM WAS LOOSE. THE STEM (AND HEAD) WAS REMOVED AND A CEMENTED STEM IMPLANTED. MALE PATIENT INITIALS MC. UNKNOWN JRN= CORAIL STEM - DISCARDED. UNKNOWN JRN+ 12/14 CERAMIC HEAD - DISCARDED. DOI: (B)(6) 2008- DOR: (B)(6) 2018 (UNKNOWN HIP).

  Patient problems: Inadequate Osseointegration; Not Applicable; Pain

  MAUDE report 7483239 ↗
• InjuryMar 20, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  DER STATES THAT THE PATIENT FELL AND WAS THEN REVISED TO ADDRESS RIGHT PROXIMAL FEMUR FRACTURE AND FEMORAL STEM LOOSENING AT THE BONE TO IMPLANT INTERFACE. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 7352269 ↗
• InjuryDec 5, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ASR REVISION, ASR XL RIGHT, REASON(S) FOR REVISION: PAIN, ALVAL/SOFT TISSUE REACTION AND RAISED COBALT AND CHROMIUM, DOI: (B)(6) 2009; DOR: (B)(6) 2017; RIGHT HIP.

  Patient problems: Pain; Tissue Damage

  MAUDE report 7085757 ↗