CORAIL 3L92514Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10603295168805), received between Jul 7, 2017 and Nov 12, 2024 — classified as 1 death, 36 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LOOSE FEMUR. REVISED STEM CHANGED LINER AND HEAD. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2017, DOR- (B)(6) 2024, AFFECTED SIDE- LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20662794 ↗
• 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 18603011 ↗
• InjuryMay 22, 2023Fracture; Fracture

  SALES REP RECEIVED INFO ABOUT A REVISION OF A FRACTURED CORAIL-STEM UNKNOWN SIDE. DOI: UNKNOWN, DOR: (B)(6) 2023.

  Patient problems: Pain

  MAUDE report 16973822 ↗
• MalfunctionJan 10, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE INSTRUMENT IS DAMAGED/WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16135073 ↗
• InjuryJul 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR CLAIMSUITE ALERTS AND RCF RECORD RECEIVED. CLAIMSUITE AND RCF ALLEGES PAIN AND INFECTION. DOI: (B)(6) 2007. DOR: (B)(6) 2022. LEFT HIP.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 14885933 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION RECORD RECEIVED. PATIENT ALLEGES PAIN AND SUFFERING, SERIOUS BODILY INJURIES, AND ECONOMIC LOSS. DOI: (B)(6) 2010 AND (B)(6) 2019, (LEFT HIP).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fatigue; Foreign Body Reaction; Metal Related Pathology; Pain; Synovitis

  MAUDE report 14073630 ↗
• MalfunctionOct 13, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT UPON OPENING THE CONTAINER IT WAS EVIDENT THAT THE PACKAGING WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12625278 ↗
• InjurySep 24, 2021Fracture; Fracture

  ADVERSE SYMPTOMS THAT LED TO REVISION: PAIN, IMMOBILITY. NO SURGICAL DELAY. ADVERSE CONSEQUENCES FOR PATIENT BECAUSE OF REPORTED EVENT: REVISION, OCCUPATIONAL ABSENCE. IMPLANT PASSPORTS ATTACHED.

  Patient problems: Insufficient Information; Loss of Range of Motion; Pain

  MAUDE report 12526409 ↗
• InjuryJun 15, 2021Fracture; Fracture

  SURGEON REPORTED TO BFARM: "CONDITION AFTER IMPLANTATION OF A CEMENTLESS HIP TEP LEFT (B)(6) 2017. ATRAUMATIC FRACTURE AT TAPER AREA OF THE CEMENTLESS HIP STEM LEFT ON (B)(6) 2021. REMOVAL/REPLACEMENT OF THE FRACTURED PROSTHESIS MATERIAL ON (B)(6) 2021.

  Patient problems: Insufficient Information

  MAUDE report 12000087 ↗
• InjuryMay 26, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Pain; Swelling/ Edema

  MAUDE report 11885874 ↗
• InjuryJan 11, 2021Fracture; Fracture

  HCP IS REPORTING A FRACTURE OF A CORAIL STEM AT TAPER AREA. DOR: (B)(6) 2020.

  Patient problems: Adhesion(s); Insufficient Information

  MAUDE report 11146906 ↗
• InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT SUFFERED A FEMORAL FRACTURE DURING HIP REPLACEMENT. THE CORAIL EXTRACTION ADAPTOR WAS THREADED AND UNABLE TO BE USED TO EXTRACT THE IMPLANT. DECISION MADE IN SURGERY TO CLOSE UP AND COME BACK WHEN INSTRUMENTS AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 11117018 ↗
• DeathDec 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EXTRACTION OF IMPLANTS FOR INFECTION. IMPLANTS REMOVED WERE A CORAIL NON COLLARED STANDARD 14 STEM AND A 1200 SERIES DURALOC 58MM CUPS WITH A 32 10 DEGREE LINER. PATIENT PASSED AWAY AFTER THE CASE AS A RESULT OF THE INFECTION HE WAS BATTLING. THE PRIMARY SURGERY DATE IS NOT KNOWN, BUT ESTIMATED TO BE 17/18 YEARS AGO. NO FURTHER DETAILS OF THE PRODUCTS INVOLVED WILL BE ABLE TO BE PROVIDED. THE PATIENT WAS VERY SICK PRIOR TO THE REVISION SURGERY AND WAS IN INTENSIVE CARE WITH SEPSIS. WHEN THE HIP WAS OPENED A LARGE VOLUME OF PUS WAS PRESENT. NO FURTHER INFORMATION IS PROVIDED.

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

  MAUDE report 11055401 ↗
• InjuryDec 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PCF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED PAIN, METALLOSIS DEBRIS IN THE JOINT, ELEVATED METAL IONS LEVELS, SCAR IN PSEUDOCAPSULE, SOME LYSIS IN THE AREA OF THE TROCHANTER, AND AREA OF ANTERIOR-SUPERIOR WALL OF THE CUP. CUP WAS REMOVED WITH MINIMAL BONE LOSS AND WAS IN RETROVERTED POSITION. DOI: (B)(6) 2008; DOR: (B)(6) 2020, RIGHT HIP. PLEASE SEE (B)(4) FOR LEFT HIP.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Osteolysis; Pain

  MAUDE report 11021552 ↗
• InjuryDec 15, 2020Degraded; Fracture; Degraded; Fracture

  LITERATURE ARTICLE ENTITLED "FRACTURE OF THE NECK OF A MODERN CEMENTLESS, TITANIUM FEMORAL STEM" WRITTEN BY EMMANUAL GIBON, MD, PHD AND JUSTIN T. DEEN, MD PUBLISHED BY ARTHROPLASTY TODAY PUBLISHED ONLINE/ACCEPTED BY PUBLISHER 3-APR-2020 WAS REVIEWED. THE ARTICLES PURPOSE WAS TO PRESENT A CASE STUDY OF PATIENT WHO EXPERIENCED A ACUTE HIP PAIN APPROXIMATELY 8 YEARS AFTER A LEFT THA. CASE STUDY: (B)(6) YEAR OLD MALE WHO HAD A LEFT HIP REPLACEMENT IN 2012 VIA ANTERIOR APPROACH. IN LATE (B)(6) 2019, HE FELT A SUDDEN POP IN HIS LEFT HIP WHILE PLAYING GOLF. THE PATIENT HADN'T EXPERIENCED ANY SYMPTOMS PRIOR TO THE EVENT. RADIOGRAPHS INDICATED A FRACTURED FEMORAL STEM. PATIENT ALSO PRESENTED WITH PAIN WITH PALPATION. PATIENT WAS SCHEDULED FOR REVISION, BUT DEVELOPED A STROKE AND PULMONARY EMBOLISM WITHIN A WEEK OF THE EVENT. THE STROKE LEFT HIM WITH A COMPLETE LEFT HEMIPARALYSIS. DURING REVISION THE STEM WAS FOUND TO HAVE EVIDENCE OF INGROWTH THROUGHOUT. THERE WAS NO EVIDENCE OF IMPINGEMENT AND NO METAL DEBRIS PRESENT. THE FEMORAL STEM HAD FRACTURED AT THE NECK. THEY WERE UNABLE TO DISENGAGE THE FEMORAL HEAD FROM THE SHORT SEGMENT OF THE TRUNNION, BUT THERE WAS VISIBLE EVIDENCE OF CORROSION

  Patient problems: Pain; Pulmonary Embolism; Stroke/CVA

  MAUDE report 11012543 ↗
• InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED BIPOLAR EXPLANT. DOI: UNKNOWN. DOR: (B)(6) 2020; UNKNOWN HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10829431 ↗
• InjuryOct 20, 2020Fracture; Fracture

  DOCTOR REPORTED A BROKEN CORAIL STEM. REVISION SURGERY TOOK PLACE. MEDICAL /PATIENT HISTORY: 2009 ASR, 2014 REVISION, NOW SECOND REVISION REQUIRED AS THE STEM IS BROKEN.

  Patient problems: No Code Available

  MAUDE report 10706099 ↗
• InjuryOct 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO EXPERIENCING PAIN. L HIP REVISION. DOI: (B)(6) 2009. DOR: (B)(6) 2020.

  Patient problems: No Code Available; Pain

  MAUDE report 10637551 ↗
• InjuryMay 6, 2020Fracture; Fracture

  THE PATIENT UNDERWENT PRELIMINARY SURGERY IN 2009, AND IN 2014 UNDERWENT A REVISION SURGERY IN THE ASR ACETABULAR PORTION AS A RESULT OF METALLIC INFECTION, WITH THE ORIGINAL STEM REMAINING IN THE FACE. AT THE BEGINNING OF THE WEEK, THE PATIENT SAT DOWN IN HIS VEHICLE AND MADE A ROTATING MOTION WITH HIS LEG, FEELING SHARP PAIN AND FROM THAT MOMENT HE COULD NO LONGER MOVE HIS LEG, EVACUATED WITH AN AMBULANCE TO THE HOSPITAL AND XRAY PHOTOGRAPHY REVEALED THAT THE STEM HAD BROKEN IN HIS NECK.

  Patient problems: No Code Available; Pain

  MAUDE report 10028717 ↗
• InjuryFeb 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED FOR PAINFUL LEFT TOTAL HIP WITH LEG LENGTH DISCREPANCY AND ONGOING SWELLING AND PAIN OF HER LEFT HIP AND COULD NOT TOLERATE THE LEG LENGTH DISCREPANCY AND LATERAL OFFSET. OPERATIVE NOTES HAS NO ADDITIONAL ALLEGATION. DOI: (B)(6) 2009; DOR: (B)(6) 2009; LEFT HIP.

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 9694260 ↗
• InjuryNov 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "LITERATURE ARTICLE ENTITLED, ¿COBALT CARDIOMYOPATHY SECONDARY TO HIP ARTHROPLASTY: AN INCREASINGLY PREVALENT PROBLEM¿ BY RUSSEL TILNEY, ET AL, PUBLISHED BY CASE REPORTS IN CARDIOLOGY, VOL. 2017, ARTICLE ID 5434571, 4 PAGES, HTTPS://DOI.ORG/10.1155/2017/5434571, WAS REVIEWED. THIS CASE REPORT DISCUSSES THE POSSIBILITY OF METAL-ON-METAL BIOTRIBOCORROSION LEADING TO CARDIOMYOPATHY SECONDARY TO COBALT HEAVY METAL POISONING WITH PARTIAL SYMPTOMATIC AND ECHOCARDIOGRAPHIC RESOLUTION ON REVISION OF THE HIP ARTHROPLASTY IN A (B)(6) GENTLEMAN. DEPUY PRODUCTS: BILATERAL ASR-XL PAIRED WITH CORAIL STEMS. PART NUMBERS WERE PROVIDED BY THE AUTHORS: LEFT HIP: ACETABULAR IMPLANT, 9998-04-754; TAPER SLEEVE ADAPTOR, 9998-00-108; FEMORAL IMPLANT, 9998-90-147; FEMORAL STEM, 3L92514 CORAIL; RIGHT HIP: ACETABULAR IMPLANT, 9998-04-652; TAPER SLEEVE ADAPTOR, 9998-00-102; FEMORAL IMPLANT, 9998-90-146, FEMORAL STEM, 3L92513 CORAIL. (B)(6) MALE WITH A HISTORY OF ALCOHOL AND SUBSTANCE ABUSE PRESENTED FOUR YEARS AFTER BILATERAL ASR-XL/CORAIL THR WITH EXERTIONAL DYSPNEA, INTERMITTENT PALPITATIONS, AND PERSISTENT TACHYCARDIA. ADMISSION ECG REVEALED, SEVERELY IMPAIRED LEFT VENTRICULAR SYSTOLIC FUNCTION IN THE ABS

  Patient problems: Atrial Fibrillation; Dyspnea; Heart Failure; Heartburn/Indigestion; Injury; No Code Available; Pain; Tachycardia; Test Result

  MAUDE report 9348660 ↗
• InjuryOct 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEW ECM RECORD CREATED IN ORDER TO UPDATE ETQ COMPLAINT NUMBER (B)(4): NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT ¿ LITIGATION ALLEGED THE PATIENT SUFFERED PAIN, PERMANENT PHYSICAL INJURIES, DISFIGUREMENT AND EXPOSURE TO EXCESSIVE LEVELS OF CHROMIUM AND COBALT AS A RESULT OF THE IMPLANTED ASR HIP. DOI: (B)(6) 2009 - DOR: (B)(6) 2019 (LEFT HIP).

  Patient problems: Calcium Deposits/Calcification; Deformity/ Disfigurement; Foreign Body Reaction; Injury; No Code Available; Not Applicable; Osteolysis; Pain; Test Result; Tissue Damage

  MAUDE report 9155899 ↗
• InjurySep 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON CONFIRMATION FORM AND CLAIMSUITE ALERT RECORDS RECEIVED. SCF AND CLAIMSUITE ALERTS ALLEGES ALVAL/SOFT TISSUE REACTION AND HIGH LEVEL OF METAL IONS. DOI: (B)(6) 2009: DOR: (B)(6) 2019: RIGHT.

  Patient problems: Foreign Body Reaction; No Code Available; Test Result

  MAUDE report 8956655 ↗
• InjuryAug 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY ID: (B)(6). ADVERSE EVENT: INTRAOPERATIVE CALCAR FRACTURE. ADVERSE EVENT DATE: (B)(6) 2016. DATE OF ONSET: (B)(6) 2016. DATE OF ACTION TAKEN: (B)(6) 2016. RELATIONSHIP TO THE STUDY DEVICE: NO RELATIONSHIP. RELATIONSHIP TO THE STUDY PROCEDURE: DEFINITE. FINAL OUTCOME: FULL RECOVERY. RANDOMIZED TO: CORAIL HA COATING. TYPE OF RE-OPERATION: NO RE-OPERATION. ACTION TAKEN: INTRAOPERATIVE REPAIR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8897538 ↗
• InjuryJul 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2019. THE PATIENT WAS SUPPOSED TO BE REVISED ON (B)(6) 2019, HOWEVER IT WAS UNSUCCESSFUL DUE TO DIFFICULTY IN REMOVING THE IMPLANTS AND BROKEN INSTRUMENTATION. PATIENT THEN HAD A SUCCESSFUL REVISION ON (B)(6) 2019 AND REPLACED WITH PROSTALAC PROSTHESIS.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8812922 ↗