CORAIL 3L93714Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295168911), received between Aug 18, 2017 and Jun 6, 2025 — classified as 20 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON FEBRUARY 15, 2012, THE PATIENT RECEIVED A RIGHT ANTERIOR APPROACH TOTAL HIP ARTHROPLASTY TO ADDRESS RIGHT HIP OSTEOARTHRITIS. METAL ON METAL IMPLANTS WERE IMPLANTED. THERE WERE NO COMPLICATIONS. ON (B)(6) 2024, PATIENT'S RIGHT HIP WAS REVISED TO ADDRESS ALVAL PSEUDOTUMOR, METALLOSIS, OSSEUS BONE EROSIONS, AND OSTEOLYSIS. THE METAL INSERT AND HEAD WERE REPLACED WITH A DUAL MOBILITY LINER CONSTRUCT. THERE WERE NO COMPLICATIONS. ON (B)(6) 2024, THE PATIENT'S RIGHT HIP WAS REVISED AGAIN TO ADDRESS PURULENT WOUND DRAINAGE, POSSIBLE INFECTION VERSUS ALVAL LESION. CULTURES OBTAINED WERE INCONSISTENT WITH INFECTION, SO THE DIAGNOSIS LEANED IN FAVOR OF ALVAL, SUBSEQUENT TO THE PREVIOUS REVISION. SURGEON REVISED AND REPLACED THE FEMORAL HEAD AND THE DUAL MOBILITY METAL AND POLY LINERS, RETAINING THE ACETABULAR CUP AND FEMORAL STEM. AND EXTENSIVE IRRIGATION AND DEBRIDEMENT WERE PERFORMED. THERE WERE NO COMPLICATIONS. THIS REPORT CAPTURES THE REVISION PROCEDURE ON (B)(6) 2024. THE SECOND REVISION IS CAPTURED ON RELATED COMPLAINT (B)(4). DOI: (B)(6) 2012. DOR: (B)(6) 2024. (ACETABULAR LINER, CUP & FEMORAL HEAD,) RIGHT HIP.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Metal Related Pathology; Osteolysis; Pocket Erosion; Swelling/ Edema

  MAUDE report 22161659 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2012, THE PATIENT RECEIVED A RIGHT ANTERIOR APPROACH TOTAL HIP ARTHROPLASTY TO ADDRESS RIGHT HIP OSTEOARTHRITIS. METAL ON METAL IMPLANTS WERE IMPLANTED. THERE WERE NO COMPLICATIONS. ON (B)(6) 2024, PATIENT'S RIGHT HIP WAS REVISED TO ADDRESS ALVAL PSEUDOTUMOR, METALLOSIS, OSSEUS BONE EROSIONS, AND OSTEOLYSIS. THE METAL INSERT AND HEAD WERE REPLACED WITH A DUAL MOBILITY LINER CONSTRUCT. THERE WERE NO COMPLICATIONS. ON (B)(6) 2024, THE PATIENT'S RIGHT HIP WAS REVISED AGAIN TO ADDRESS PURULENT WOUND DRAINAGE, POSSIBLE INFECTION VERSUS ALVAL LESION. CULTURES OBTAINED WERE INCONSISTENT WITH INFECTION, SO THE DIAGNOSIS LEANED IN FAVOR OF ALVAL, SUBSEQUENT TO THE PREVIOUS REVISION. SURGEON REVISED AND REPLACED THE FEMORAL HEAD AND THE DUAL MOBILITY METAL AND POLY LINERS, RETAINING THE ACETABULAR CUP AND FEMORAL STEM. AND EXTENSIVE IRRIGATION AND DEBRIDEMENT WERE PERFORMED. THERE WERE NO COMPLICATIONS. THIS REPORT CAPTURES THE REVISION PROCEDURE ON (B)(6) 2024. THE PREVIOUS REVISION IS CAPTURED ON RELATED COMPLAINT (B)(4). DOI: (B)(6) 2012. DOI: (B)(6) 2024. DOE: (B)(6) 2024.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Osteolysis; Pain; Pocket Erosion; Purulent Discharge; Unspecified Infection

  MAUDE report 22161386 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO HIP INFECTION. DURING THE FIRST STAGE OF THE TWO STAGE PROCEDURE, THE PATIENT'S PRIMARY IMPLANTS WERE REMOVED AND REPLACED BY A PROSTALAC ANTIBIOTIC SPACER. ONCE THE INFECTION HAS CLEARED, THE PATIENT WILL UNDERGO THE SECOND STAGE OF THE TWO STAGE PROCEDURE. DURING THIS STAGE, THE PROSTALAC SPACER WILL BE REMOVED AND REVISION COMPONENTS WILL BE IMPLANTED. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17450535 ↗
• InjuryMar 9, 2023Osseointegration Problem; Osseointegration Problem

  REVISION COMPLETED DUE TO PERIPROSTHETIC FRACTURE. THERE WAS A LOOSENING REPORTED IN FEMORAL STEM AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 16512400 ↗
• InjuryDec 20, 2022Degraded; Degraded

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO PAIN AND STIFFNESS. DATE OF IMPLANT: ON (B)(6) 2009. DATE OF REVISION: ON (B)(6) 2022. (LEFT HIP). TREATMENT: REVISION; HAND AND LINER REVISED.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Muscular Rigidity; Pain

  MAUDE report 16016169 ↗
• InjuryAug 30, 2022Fracture; Migration; Fracture; Migration

  PINNACLE LITIGATION RECORD RECEIVED. LITIGATION ALLEGES FRACTURED STEM, POST OP COMPLICATION WAS URINARY RETENTION AND SEVERE PAIN. X-RAY REPORTED ACUTE ANGULATION OF THE RIGHT FEMORAL NECK. NO PERIPROSTHETIC FRACTURE. DOI: (B)(6) 2015; DOR: (B)(6) 2021 ; RIGHT HIP.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Paresthesia

  MAUDE report 15320910 ↗
• InjuryMar 8, 2022Osseointegration Problem; Migration; Osseointegration Problem; Migration

  THE PATIENT WAS REVISED DUE TO LOOSENING OCCURRED IN THE FEMORAL STEM. THE ORIGINAL STEM WAS UNDERSIZED. THE POLY WAS CHANGES AND THE SCREWS WERE REMOVED. DOI: (B)(6) 2016. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13693548 ↗
• InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS, END-STAGE. DEPUY COMPONENTS, INCLUDING 2 SCREWS WERE USED DURING THE PROCEDURE. DURING THE PROCEDURE THE SURGEON REPORTED HAVING SOME FRAGMENTATION OF THE TROCHANTER. THE SURGEON FELT THAT THE HIP WAS STABLE, BUT BECAUSE OF THE FRAGMENTATION, THE PATIENT WILL AVOID ACTIVE ABDUCTION POSTOPERATIVELY. ON (B)(6) 2021 PATIENT IS EXPERIENCING THIGH PAIN AND LIMP STATUS POST RIGHT ANTERIOR HIP REPLACEMENT WITH SMALL GREATER TROCHANTER FRACTURE INTRAOPERATIVELY. NO INVASIVE TREATMENT. IT SHOULD BE NOTED THAT THIS IS ONLY 14 DAYS AFTER IMPLANTING OF THE HIP, AND PAIN AND LIMPING ARE AN EXPECTED EVENT IN THAT TIME RANGE.

  Patient problems: Limb Fracture

  MAUDE report 12041507 ↗
• MalfunctionJan 13, 2021Expiration Date Error; Expiration Date Error

  A. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? B. WAS THERE A SURGICAL DELAY BECAUSE OF THIS EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? C. WAS THERE ANY ISSUES WITH THE CLARITY OF THE LABELING THAT LED TO THE EXPIRED PRODUCT BEING USED? ANSWER: THERE WASN'T ANY ADVERSE REACTIONS TO THE PATIENT, AND THE TIME OF THE SURGERY WASN'T EXTENDED DUE TO THE FACT THAT THE SURGEON DIDN'T WANT TO WAIT FOR A NON EXPIRED IMPLANT TO BE BROUGHT TO THE HOSPITAL. THE FACT THAT THE EXPIRED IMPLANT WAS MISSED BY OUR LOCAL OFFICE, AND THE REP COVERING THE CASE WAS A RARE OVERSIGHT, AND HAS SINCE BEEN DISCUSSED, WE HAVE HAD SEVERAL TRAININGS, AND ALSO BEEN REQUIRED BY OUR LOCAL DISTRIBUTOR TO RECHECK ALL CURRENT INVENTORY IN OUR WAREHOUSE AND HOSPITALS WHERE THERE ARE IMPLANTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11164134 ↗
• InjuryNov 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED TO PROSTALAC FOR INFECTION. MULTIPLE IMPLANT DATES DUE TO A DISLOCATION. DOI: STEM (B)(6) 2019, HEAD (B)(6) 2020. DOR: (B)(6) 2020. AFFECTED SIDE: LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10809317 ↗
• InjuryJul 14, 2020Loss of Osseointegration; Migration; Loss of Osseointegration; Migration

  IT WAS REPORTED THAT THE PATIENT STEM SUBSIDED DUE TO BAD BONE. REMOVED STEM AND CEMENTED A SUMMIT IN. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT SIDE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10270999 ↗
• InjuryApr 6, 2020Corroded; Naturally Worn; Corroded; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR UNKNOWN REASON. THERE WAS REMOVAL OF METAL LINER AND CERAMIC HEAD (PINNACLE) REPLACEMENT AT CERAMIC HEAD AND POLY LINER (ALTRX). DOI: (B)(6) 2013; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Adhesion(s); No Code Available; Pain

  MAUDE report 9930222 ↗
• InjuryOct 16, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE NECK OF STEM BROKE JUST ABOVE THE BASE OF TRUNNION WHILE PATIENT WAS WALKING. TRUNNION PIECE REMAINED IN THE FEMORAL HEAD. DOI: (B)(6) 2010; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 9196618 ↗
• InjuryMay 10, 2019Inadequacy of Device Shape and/or Size; Loss of Osseointegration; Inadequacy of Device Shape and/or Size; Loss of Osseointegration

  SURGEON COMMENTED REASON FOR REVISION DUE TO STEM LOOSENING LIKELY CAUSED BY IMPLANT BEING UNDERSIZED WHICH HAS SUBSEQUENTLY CAUSED INFECTION.

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

  MAUDE report 8599729 ↗
• InjuryFeb 8, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  ON 27 JUL 2017: LITIGATION RECEIVED. LITIGATION ALLEGES CUP HAD DETACHED, DISCONNECTED, CREATED METALLIC DEBRIS, AND/OR LOOSENED WHICH CAUSED SEVERE PAIN, LIMITED MOBILITY. UPDATE AD 11 MAY 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS RECORD. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2011 - DOR: (B)(6) 2016, (RIGHT HIP).

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain; Test Result; Tissue Damage

  MAUDE report 8319969 ↗
• InjuryJan 3, 2019Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, TOXIC LEVELS OF COBALT CHROMIUM, AND TISSUE DAMAGE. PPF ALLEGES LOOSENING OF STEM AND ELEVATED METAL IONS. DOI: (B)(6) 2008 - DOR: (B)(6) 2012 (LEFT HIP).

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

  MAUDE report 8212127 ↗
• InjuryDec 3, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  A SIZE 14 CORAIL COXA VARA (ANGLED) STEM GOT STUCK ON INTRODUCTION 10MM FROM CALCAR. THIS WAS A DORR A TYPE FEMUR. DELAY IN THEATRE: YES ¿ CONVERTED TO A CEMENTED C-STEM AMT AS NO OTHER SIZE 14 AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 8123998 ↗
• InjuryJul 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, POPPING/SNAPPING, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL IONS AND PARTICLES. PFS AND MEDICAL RECORDS WERE RECEIVED FROM LEGAL AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW.

  Patient problems: Discomfort; Inflammation; Pain; Test Result

  MAUDE report 7657940 ↗
• InjuryJun 29, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ASR REVISION; ASR XL ACETABULAR SYSTEM - RIGHT; REASON FOR REVISION: PAIN & METALOSIS, COBALT CHROMIUM. UPDATE: FORM 57 ATTACHED, FURTHER REASON FOR REVISION & PRODUCT DETAILS, (B)(6).UPDATE SPREADSHEET DATED 28TH OCT 2011. UPDATE 07 JUN 2018. (B)(4) IS A REOPENED OF (B)(4) BECAUSE OF A NEW ALERT RECEIVED. THERE IS NO NEW ALLEGATION THAT WILL CHANGE THE MDR REPORTABILITY. THE MANUFACTURING DATES WERE UPDATED. DOI: (B)(6) 2006; DOR: (B)(6) 2011; RIGHT HIP.

  Patient problems: No Code Available; Pain; Test Result; Tissue Damage

  MAUDE report 7651108 ↗
• InjuryFeb 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION. IT WAS ALSO REPORTED THAT PATIENT HAS FAILED POLY EXCHANGE. DOI: UNKNOWN; DOR: UNKNOWN; RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 7302778 ↗
• InjuryAug 18, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED SEVERE OSTEOLYSIS OF RIGHT HIP POST METAL ON METAL HIP IMPLANTATION WITH A COMMINUTED RIGHT HIP PERIPROSTHETIC PROXIMAL FEMUR FRACTURE. PRIOR TO REVISION PATIENT ALLEGED HIP PAIN. NO REVISION NOTES REPORTED. ADDED ACCOUNT NAME, DATE OF BIRTH AND GENDER OF PATIENT, LAW FIRM, REPORT SOURCE, DATE OF IMPLANT, EXPIRATION DATE OF LINER AND HEAD AND MEDICAL HISTORY. CORRECTED PATIENT'S INITIAL. DOI: (B)(6) 2008; DOR: (B)(6) 2017; RIGHT HIP

  Patient problems: Bone Fracture(s); Foreign Body Reaction; No Code Available; Osteolysis; Pain

  MAUDE report 6805243 ↗