CORAIL 3L92513Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10603295168799), received between Jul 13, 2017 and Aug 18, 2025 — classified as 52 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS REVISED FOR A TOTAL HIP REPLACEMENT DUE CHRONIC INFECTION. ORIGINAL OPERATION FOR THE THR WAS ON AN UNKNOWN DATE IN 2018. ALL IMPLANTS WERE REMOVED AND STRYKER CEMENTED IMPLANTS IMPLANTED DUE TO INFECTION. ALL IMPLANTS WERE WELL FIXED WITH SIGNS ON BONE INTEGRATION AND ON GROWTH. NO FURTHER PATIENT CONSEQUENCES.

  Patient problems: Unspecified Infection

  MAUDE report 22832563 ↗
• InjuryMar 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT PATIENT HAD A POSTOPERATIVELY FRACTURED CORAIL HIP STEM, UNKNOWN SIDE. HIP CUP AND HIP INLAY WERE COMPETITOR PRODUCTS PATIENT HAD PREVIOUSLY BEEN REVISED ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 21536463 ↗
• InjuryNov 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT ON (B)(6) 2009. PATIENT UNDERWENT A LEFT HIP SURGERY USING ASR XL IMPLANTS. ON (B)(6) 2024, PATIENT UNDERWENT A LEFT HIP REVISION, DUE TO PAIN. DOI: (B)(6) 2009. DOR: (B)(6) 2024. LEFT HIP.

  Patient problems: Pain

  MAUDE report 20600714 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE AD 14 JUN 2024 MEDICAL RECORDS RECEIVED : PATIENT UNDERWENT REVISION DUE TO EXTENSIVE METALLOSIS INVOLVING PROXIMAL FEMUR, HIP ABDUCTOR MUSCULATURE, TROCHANTERIC BURSA AND HIP CAPSULE WITH INTACT FIXATION OF DISTAL FEMORAL STEM AND ACETABULAR COMPONENT. THE SURGERY ENTAILED REMOVAL OF THE STEM THROUGH AN EXTENDED TROCHANTERIC OSTEOTOMY; REMOVAL OF THE METAL LINER AS WELL AS REMOVAL OF THE ACETABULAR CUP. EXTENSIVE BROWN COLORED FLUID WAS FOUND IN THE HIP CAPSULE AND METAL DEBRIS WAS DEBRIDED THROUGHOUT THE HIP. A CONSTRAINED LINER WAS USED TO MITIGATE THE POTENTIAL FOR POSTOPERATIVE INSTABILITY AS THE SURGEON DID NOT FEEL A DUAL MOBILITY ARTICULATION WOULD PROVIDE ADEQUATE STABILITY IN THE ABSENCE OF A FULLY INTACT ABDUCTOR MECHANISM. EXTENSIVE ABDUCTOR DAMAGE WAS FOUND. DOI: (B)(6) 2008. DOR: (B)(6) 2023. AFFECTED HIP : RIGHT.

  Patient problems: Foreign Body Reaction; Inflammation; Joint Laxity; Unspecified Tissue Injury

  MAUDE report 19610482 ↗
• 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 18602995 ↗
• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE OF LEFT HIP. BI-MENTUM LINER AND HEAD WERE IMPLANTED. SURGEON ELECTED TO USE COMPETITOR STEM AND COMPETITOR FEMORAL HEAD. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 17895902 ↗
• InjuryJun 2, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND SUSTAINED A PERIPROSTHETIC FEMUR FRACTURE. STEM WAS LOOSE AS A RESULT OF THE FRACTURE. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 17049218 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. SURGEON REMOVED ALL IMPLANTS AND PLACED A ANTIBIOTIC SPACER. THERE WAS NO LOOSENING AND SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15631269 ↗
• InjuryAug 12, 2022Degraded; Degraded

  IT WAS REPORTED THAT THE SURGEON REMOVED THE ASR SHELL, FEMORAL HEAD, TAPER INSERT. DOI: UNKNOWN. DOR: (B)(6) 2021, (UNKNOWN SIDE).

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Necrosis

  MAUDE report 15216193 ↗
• InjuryMar 7, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED A LOOSE FEMORAL STEM. STEM WAS REVISED. THE METAL PINNACLE LINER WAS REMOVED AND A DUAL MOBILITY LINER WAS PUT IN PLACE. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13685278 ↗
• InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  ASR REVISION: ASR XL ACETABULAR SYSTEM - RIGHT HIP. REASON(S) FOR REVISION: AS PER ED REPORT PATIENT HAVE EXPERIENCED INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASE, BLEEDING AND DOES REQUIRE REVISION. NO POST-OP DEVICE MALFUNCTION. DOI: (B)(6) 2009; DOR: (B)(6) 2013; RIGHT HIP.

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

  MAUDE report 11967404 ↗
• InjuryMar 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED PRIMARY HIP-TEP RIGHT SIDE WITH MOM ON (B)(6) 2007. HE IS REPORTING PAIN AND INCREASED COCR-LEVELS. REVISION OF ACETABULAR COMPONENTS ON (B)(6) 2021. PATIENT PRESENTED TO THE ATTENDING PHYSICIAN ON (B)(6) 2020, FOR UNSPECIFIED SYMPTOMS, FOR WHICH CT SCAN AND X-RAYS "SHOWED EXTENSIVE OSTEOLYSIS, MOST LIKELY IN LINE WITH ABRASION DUE TO THE METAL/METAL TRIBOLOGICAL PAIRING IN THE AREA OF THE TROCHANTER REGION". SUBSEQUENTLY, THE (UNSPECIFIED) SYMPTOMS INTENSIFIED. ADDITIONAL X-RAYS SHOWED THAT THE OSTEOLYSIS HAD BROKEN THROUGH THE TROCHANTER REGION AND THAT A MINOR PLATE HAD FRACTURED OFF, ALTHOUGH THE TROCHANTER REGION REMAINED INTACT. NO LABS WERE PROVIDED THAT ADDRESSED METAL ION LEVELS. A RIGHT TOTAL HIP REVISION TOOK PLACE ON (B)(6) 2021, TO ADDRESS "PRONOUNCED METALLOSIS (SYSTEMIC AND LOCALIZED) WITH OSTEOLYSIS IN THE LATERAL GREATER TROCHANTER REGION ON THE RIGHT WITH METAL ON METAL IMPLANT FAILURE (IMPLANTATION 2007)". THE METAL LINER WAS REPORTEDLY "IMMOVABLY CORRODED" TO THE DEGREE THAT THE CUP AND LINER (WITH HOLE ELIMINATOR) HAD TO BE EXPLANTED AS A WHOLE CONSTRUCT. CUP, HOLE ELIMINATOR, METAL LINER, AND FEMORAL HEAD WERE ALL REVISED TO COMPETITOR PRODUCT

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Limb Fracture; Pain

  MAUDE report 11566056 ↗
• InjuryMar 23, 2021Fracture; Fracture

  SALES REP WAS INFORMED ABOUT A FRACTURED CORAIL HIP STEM. NO SURGICAL DELAY DURING REVISION SURGERY. AFFECTED SIDE: LEFT. DOI: UNKNOWN, DOR (PLANNED): (B)(6) 2021.

  Patient problems: Insufficient Information

  MAUDE report 11553189 ↗
• InjuryFeb 22, 2021Osseointegration Problem; Migration; Osseointegration Problem; Migration

  A PATIENT OPERATED ON (B)(6) 2018, PRESENTS PAIN AND PERFORMS CONTROL X-RAYS, IT SHOWED THAT THE STEM CHANGED ITS POSITION. THEY PERFORMED A HIP REVISION AND REPORTED THAT THEY FOUND THAT THE STEM IS LOOSE AND HAD NO METAPHYSEAL FIXATION.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 11357752 ↗
• InjuryFeb 2, 2021Osseointegration Problem; Osseointegration Problem

  REP WAS NOTIFIED BY SURGEON THAT A PATIENT HE¿D SEEN IN CLINIC NEEDED A HIP REVISION DUE TO A FALL ON THE OPERATIVE LEG, LEFT SIDE. PATIENT EXPERIENCED A FORWARD FALL ONTO THEIR LEFT KNEE AND EXPERIENCED PAIN AFTERWARDS. SURGEON SAW PATIENT POST-FALL AND ORDER X-RAYS WHICH SHOWED NO FRACTURES. SURGEON ORDERED A SECOND SERIES OF X-RAYS THAT DID SHOW A FRACTURE. SURGEON ELECTED TO REMOVE THE FEMORAL STEM, FEMORAL HEAD, AND LINER. HE ELECTED TO LEAVE THE PINNACLE SHELL IN. UPON REVISION SURGERY, THE PINNACLE LINER WAS WELL FIXED AND REMOVED WITH LINER REMOVAL DEVICE. FEMORAL HEAD HAS DISENGAGED WITH A TAMP. FEMORAL STEM WAS FOUND TO BE LOOSE. THE HA COATING WAS GONE FROM THE IMPLANT. THE DOCTOR THEN ELECTED TO PUT A NEW LINER IN THE SHELL TO ACCOMMODATE AND LARGER DIAMETER FEMORAL HEAD AND THEN USED CABLES AND A COMPETITORS STEM TO ADDRESS THE FEMUR. NO INSTRUMENTS BROKE DURING SURGERY. DOCTOR DID NOT MENTION THAT ANY PRODUCTS DID NOT DO WHAT THEY WERE SUPPOSED TO.

  Patient problems: Bone Fracture(s); Fall; Inadequate Osseointegration; Pain

  MAUDE report 11267841 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  ASR REVISION. ASR XL: RIGHT HIP. REASON FOR REVISION: PAIN. DOI: (B)(6) 2009; DOR: (B)(6) 2019: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 11177081 ↗
• InjuryOct 27, 2020Degraded; Degraded

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED DUE TO PERIPROSTHETIC OSTEOLYSIS OF INTERNAL PROSTHETIC LEFT HIP JOINT, 16X11X6CM PSEUDOTUMOR CYST MASS WITH METALLOSIS CONTENTS WITHIN THE CYST, PAIN AND BONE LOSS. COBALT AND CHROMIUM LEVELS ARE WITHIN NORMAL LEVEL. PINNACLE LITIGATION RECORD RECEIVED. LITIGATION ALLEGES CORROSION, WEAR, TOXIC COBALT-CHROMIUM METAL DEBRIS, METALLOSIS RESULTING TO PAIN, DIFFICULTY WALKING, LOSS RANGE OF MOTION AND MENTAL ANGUISH. PLAINTIFF IS SEEKING COMPENSATION FOR ALL THE DAMAGES. DOI: (B)(6) 2010; DOR: (B)(6) 2019 ; LEFT HIP. DOI: (B)(6) 2010 - DOR: (B)(6) 2019 (LEFT HIP).

  Patient problems: Ambulation or Postural Difficulties; Cyst(s); Foreign Body Reaction; Hypersensitivity/Allergic reaction; Injury; Limited Mobility Of The Implanted Joint; No Code Available; Osteolysis; Pain

  MAUDE report 10740713 ↗
• InjuryMay 4, 2020Fracture; Fracture

  RECEIVED A X-RAY OF A POST THR PATIENT, SEEMS A BROKEN STEM FROM THE NECK AND LOOKS JNJ CORAIL PINNACLE PRODUCT. PATIENT WAS COMPLAINING SEVERE PAIN IN RIGHT SIDE OF HIP, INABILITY TO STAND AND INABILITY TO WALK. PATIENT ALSO INFORMED SURGEONL THAT HE GOT FALLEN DURING HIS ROUTINE WORK. PATIENT ALSO INFORMED TO SURGEON THAT HIS RIGHT HIP WAS ALREADY OPERATED IN 2018 DUE TO AVN BY ANY OTHER SURGEON FROM THE PATNA, & RT HIP WAS IMPLANTED WITH JNJ PRODUCT. AND PATIENT HAS ALSO REPORTED THAT HE IS HAVING PAIN IN HIS RT HIP (OPERATED SITE) AND GETTING SOME UNUSUAL SOUND SINCE LAST ONE YEAR.

  Patient problems: Ambulation or Postural Difficulties; Fall; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 10022556 ↗
• InjuryApr 3, 2020Loss of Osseointegration; Loss of Osseointegration

  NOW THAT THE OPERATION REPORT IS AVAILABLE AND AFTER CONSULTATION WITH THE ATTENDING DOCTOR AT THE SPEISING ORTHOPEDIC HOSPITAL, IT HAS BECOME APPARENT THAT THERE HAS BEEN AN OBVIOUS LOOSENING OF THE IMPLANT AND A MASSIVE PAIN SITUATION DUE TO METAL ABRASION, WITH MASSIVE METAL-SYNOVITIC TISSUE HAVING TO BE REMOVED INTRAOPERATIVELY. DOI: (B)(6) 2009. DOR: (B)(6) 2019, (RIGHT HIP).

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Joint Disorder; Limited Mobility Of The Implanted Joint; No Code Available; Osteolysis; Pain; Swelling

  MAUDE report 9921903 ↗
• InjuryFeb 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCED PAIN IN THE RIGHT HIP WHILE WALKING.

  Patient problems: No Code Available; Pain

  MAUDE report 9765323 ↗
• InjuryJan 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS A FAILED ASR METAL-ON-METAL HIP WITH OSTEOLYSIS IN THE PROXIMAL FEMUR AND ACETABULUM. INTRAOPERATIVELY, DARK BLACK FLUID EXTRUDED AND THERE WAS FLORID BLACK STAINING OF THE HIP JOINT WITH FLORID SYNOVITIS, NECROSIS AND OSTEOLYSIS. IT WAS INDICATED THAT THERE WAS OSTEOLYSIS ALONG THE STEM. DOI: (B)(6) 2006. DOR: (B)(6) 2018, (RIGHT HIP).

  Patient problems: Edema; Foreign Body Reaction; Necrosis; No Code Available; Osteolysis; Pain; Test Result

  MAUDE report 9570176 ↗
• InjuryJan 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR REVISION.  ASR XL. RIGHT HIP. REASON FOR REVISION: PAIN. DOI: (B)(6) 2008; DOR: (B)(6) 2018.

  Patient problems: Pain

  MAUDE report 9559328 ↗
• InjuryNov 20, 2019Corroded; Corroded

  "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; Foreign Body Reaction; Heart Failure; Heartburn/Indigestion; Hypersensitivity/Allergic reaction; Injury; No Code Available; Pain; Tachycardia; Test Result

  MAUDE report 9348663 ↗
• InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED VIA THA WITH A CUP (MANUFACTURED BY STRYKER), THE STEM (P:N/ 3L92513) AND THE HEAD (P:N/ 136536320) ON (B)(6) 2018. IT WAS REPORTED THAT THE PATIENT FELL FROM THE SECOND FLOOR ON (B)(6) 2019. THE FRACTURE AROUND THE STEM AND TIBIAL PLATEAU FRACTURE OCCURRED. THE REVISION SURGERY WAS PERFORMED BY REPLACING THE STEM AND THE HEAD WITH AN ARCOS (MANUFACTURED BY ZIMMER BIOMET, P:N/ UNKNOWN) AND A PLATE (MANUFACTURED BY SYNTHES, P:N/ UNKNOWN) ON (B)(6) 2019. THE SURGICAL DELAY AND THE PATIENT OUTCOME ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 9322138 ↗
• InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES DISLOCATION AND ELEVATED METAL IONS. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED DUE RECURRENT DISLOCATION. OPERATIVE NOTES REPORTED, THERE WAS SOME METALLOSIS AS WELL AS SIGNIFICANT FLUID ANTERIOR. THERE DID NOT APPEAR TO BE ANY OBVIOUS IMPINGEMENT WHICH CAUSES DISLOCATION HOWEVER WITH THE CAPSULE BEING TORN THERE WAS EXTRA SPACE ANTERIORLY WHICH ALLOWED FOR THE HIP TO SUBLUX ANTERIORLY. DOI: (B)(6) 2012. DOR: (B)(6) 2012, (LEFT HIP, SECOND REVISION). PLEASE SEE (B)(4), FOR THE FIRST REVISION.

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

  MAUDE report 9207719 ↗