CORAIL L20313Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 10603295258049), received between Jul 14, 2017 and Jun 25, 2026 — classified as 68 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (10 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 72 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2026Osseointegration Problem

  IT WAS REPORTED CAME IN WITH A PERI PROSTHETIC FRACTURE FROM A FALL. THE LOOSE CORAIL STEM WAS REMOVED AND REINSERTED WITH RECLAIM MODULAR FOR DISTAL FIXATION TO REGAIN LENGTH FROM THE FRACTURE. DOI-(B)(6) 2017 DOR(B)(6) 2026 AFFECTED SIDE-LEFT HIP.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 25621616 ↗
• InjuryJun 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION OF A CORAIL STEM AND HEAD DUE TO THE A NECK FRACTURE OF THE STEM. PATIENT'S PRIMARY HIP WAS DONE IN 2008. PATIENT WAS REVISED ON (B)(6) 2009 FROM AN ASR XL HEAD TO A PINNACLE CUP AND CERAMIC LINERS DUE TO METALOSIS DUE TO PROBABLE HIGH ANGLE OF INCLINATION AND EDGE LOADING. PATIENT SUSTAINED NO FALL, JUST COMPLAINED SHE HAD A SORE HIP. AFFECTED SIDE: RIGHT SIDE (B)(4) CAPTURES THE REVISION IN 2009. (B)(4) CAPTURES THE REVISION OF A CORAIL STEM AND HEAD DUE TO THE A NECK FRACTURE OF THE STEM.

  Patient problems: Discomfort; Fall

  MAUDE report 22298732 ↗
• InjuryApr 29, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE ALL PARTS WERE REMOVED DUE TO INFECTION OF THE HIP JOINT. THERE WAS STEM LOOSENING FROM INFECTION AT THE NON-CEMENTED INTERFACE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 21924950 ↗
• MalfunctionApr 24, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT AT THE TIME OF THE PREPARATION OF THE IMPLANTS PRE-OPERATIVELY, IT WAS EVIDENT THAT IT HAS THE FIRST HAD A RIPPED WRAPPER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21902292 ↗
• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION AND MEDICAL RECORD RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS BILATERAL ADVERSE REACTION TO METAL DEBRIS, ELEVATED METAL IONS, CYSTS IN TROCHANTERIC REGION AND PSEUDOTUMOR. CLINICAL VISIT REPORTED MUSCLE FATIGUE, CYST AND SOME LUCENCY ON HIS FEMORAL COMPONENT. OPERATIVE NOTE REPORTED LARGE FLUID COLLECTION AROUND HIPS ENCOUNTERED. THERE WERE LARGE CYSTIC LESION ALONG WITH SOME NECROTIC TISSUE. THERE WAS A HYPERTROPHIC REACTION IN THE SYNOVIUM. THESE WERE DEBRIDED AND HIP REDUCTION WERE PERFORMED. HOWEVER, THERE WERE NO METALLOSIS. METAL LINER AND HEAD WERE REVISED TO CERAMIC ON CERAMIC. DOI: MAY 25, 2007; DOR: SEP 12, 2012; RIGHT HIP.

  Patient problems: Cyst(s); Fatigue; Hypersensitivity/Allergic reaction; Metal Related Pathology; Necrosis; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 19654724 ↗
• InjuryJun 25, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THERE WAS A REVISION FOR STEM LOOSENING. NO OTHER INFORMATION AVAILABLE. DOI- (B)(6) 2012. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19606401 ↗
• InjuryJun 13, 2024Osseointegration Problem; Osseointegration Problem

  LITIGATION AND MEDICAL RECORDS RECEIVED. PLAINTIFF HAD A TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 DUE TO SEVERE DEGENERATIVE JOINT DISEASE. PLAINTIFF UNDERWENT A TOTAL HIP ARTHROPLASTY REVISION ON (B)(6) 2023 DUE TO SIGNIFICANT OSTEOLYTIC MATERIAL NOTED THROUGHOUT THE PROXIMAL FEMUR, GRAYISH TYPE FLUID NOTED THROUGHOUT SOFT TISSUE. PLAINTIFF UNDERWENT WORKUP WHICH SHOWED THAT THERE WAS LOOSENING OF THE FEMORAL STEM. THIS IS A METAL ON METAL ARTICULATION AND COBALT AND CHROMIUM BLOOD LEVELS WERE NOTED TO BE ELEVATED AND RECOMMENDED THAT HE PROCEED WITH REVISION OF THE FEMORAL COMPONENT AND REMOVAL OF THE ACETABULAR LINER TO CONVERT TO A DUAL MOBILITY TYPE CONSTRUCT. PLANS WERE THEN MADE TO PROCEED WITH REVISION OF ACETABULUM AND FEMUR. DOI: (B)(6) 2008. DOR: (B)(6) 2023. RIGHT HIP.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Metal Related Pathology; Osteolysis; Unspecified Tissue Injury

  MAUDE report 19527398 ↗
• InjuryMay 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PERIPROSTHETIC FRACTURE OF THP AND PAIN, FOLLOWING A FALL. NO SURGICAL DELAY. AFFECTED SIDE: LEFT.

  Patient problems: Fall; Limb Fracture; Pain

  MAUDE report 19403965 ↗
• 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 18603054 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PLAINTIFF FACT SHEET ALLEGED PLAINTIFF SUFFERED STAPH INFECTION AND PAIN WHEN WALKING POST REVISION.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17169936 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE AD 5 APR 2023: ON OR ABOUT (B)(6) 2023, PATIENT SUFFERED THE FOLLOWING PERSONAL AND ECONOMIC INJURIES AS A RESULT OF THE IMPLANTATION WITH THE ASR HIP IMPLANT: SEVERE PAIN AND DISCOMFORT, INCREASED METAL LEVELS IN BLOOD INCLUDING COBALT AND CHROMIUM; PERMANENT INJURIES, EMOTIONAL DISTRESS, DISABILITY, DISFIGUREMENT; ECONOMIC DAMAGES INCLUDING MEDICAL AND HOSPITAL EXPENSES FOR REVISION SURGERY FOLLOWED BY MONITORING, REHABILITATION AND PHARMACEUTICAL COSTS. AS A RESULT, PATIENT HAS SUSTAINED AND WILL SUSTAIN DAMAGES IN AN AMOUNT TO BE PROVEN AT TRIAL. DOI : (B)(6) 2008. DOR : (B)(6) 2023. AFFECTED SIDE : RIGHT HIP.

  Patient problems: Anxiety; Deformity/ Disfigurement; Discomfort; Distress; Foreign Body Reaction; Metal Related Pathology; Muscle/Tendon Damage; Pain; Swelling/ Edema; Thrombosis/Thrombus; Unspecified Tissue Injury

  MAUDE report 16783749 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND WAS REVISED FOR PERIPROSTHETIC FRACTURE. NOTHING FURTHER TO REPORT. NO LOOSENING, NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Limb Fracture

  MAUDE report 16379443 ↗
• InjuryJan 12, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMUR. LOOSENING INTERFACE WAS NON-CEMENTED. AFTER UNDERGOING THA ON (B)(6) 2022, THE STEM SUBSIDED INTO THE FEMUR. SURGEON STATED HE MAY OF DONE SOMETHING WHILE INSERTING THE STEM THAT WENT UNNOTICED. SURGEON REMOVED STEM AND REPLACED WITH A RECLAIM STEM. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16146549 ↗
• InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF CORAIL PINNACLE THR DUE TO PERI-PROSTHETIC FRACTURE. VANCOUVER B2 TYPE FRACTURE. STEM WAS REMOVED AND ZIMMER DISTAL FIXING STEM INSERTED. DUE TO AGE OF LINER IT WAS ALSO CHANGED FOR NEW ALTRX ONE. HEAD AND LINER SHOWED MINIMAL WEAR AND NIL FURTHER ISSUES. DOI: UNKNOWN. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Fall; Limb Fracture

  MAUDE report 16120530 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE LITIGATION COMPLAINT RECEIVED AD (B)(6) 2022. PATIENT WAS REVISED DUE TO HEAVY METAL POISONING FROM THE TOXIC HEAVY METALS. RECORDS ALSO ALLEGES PAIN, INJURY, SUFFERED ADDITIONAL SCAR TISSUE FORMATION, METALLOSIS, METAL WEAR, LOSS OF ENJOYMENT OF LIFE, LIMITATION OF DAILY ACTIVITIES, EMOTIONAL TRAUMA, AND DISTRESS. DOI: (B)(6) 2008. DOR: (B)(6) 2021. UNK HIP.

  Patient problems: Adhesion(s); Distress; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Loss of Range of Motion; Metal Related Pathology; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 16086782 ↗
• InjuryAug 18, 2022Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE FEMUR. THERE WAS LOOSENING OF THE STEM AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 15249208 ↗
• InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MOM PINNACLE LITIGATION RECORD RECEIVED. PATIENT ALLEGES ELEVATED METAL ION, SUFFERED INJURY TO HIS MUSCLE AND TISSUE, SUFFERED ADDITIONAL SCAR TISSUE FORMATION, AND NOW HAS A HIP REPLACEMENT WITH DECREASED LONGEVITY, SUFFERED INJURIES, PAIN, METALLOSIS, METAL WEAR, LOSS OF ENJOYMENT OF LIFE, LIMITATION OF DAILY ACTIVITIES, PHYSICAL DISABILITY, EXPERIENCED EMOTIONAL TRAUMA AND DISTRESS, MENTAL ANGUISH, AND ECONOMIC LOSS, PERMANENT INSTABILITY AND LOSS OF BALANCE, IMMOBILITY, AND SUFFERING. DOI: (B)(6) 2010, DOR: (B)(6) 2021, (UNKNOWN HIP).

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Blurred Vision; Discomfort; Distress; Dizziness; Ecchymosis; Fatigue; Foreign Body Reaction; Headache; Hearing Impairment; Hemorrhage/Blood Loss/Bleeding; Itching Sensation; Loss of Range of Motion; Metal Related Pathology; Muscular Rigidity; Necrosis; Numbness; Pain; Rash; Swelling/ Edema; Synovitis; Thrombosis/Thrombus; Unspecified Tissue Injury

  MAUDE report 14874504 ↗
• InjuryOct 21, 2021Osseointegration Problem; Osseointegration Problem

  FACTS ALLEGED AND REPORTED BY THE APPLICANT. THE PATIENT HAS BILATERAL HIP OSTEOARTHRITIS. THE PATIENT UNDERWENT SURGERY FOR THE PLACEMENT OF A HIP REPLACEMENT. THE INTERVENTION CONSISTED OF A BILATERAL HIP REPLACEMENT. THE SURGICAL INTERVENTION WAS PERFORMED AND THE PROSTHESIS PLACED WAS MADE BY J&J. IN 2019, THE PATIENT BEGAN TO EXPERIENCE HIP PAIN AND AN MRI WAS PERFORMED. THE RESULT OF THE MRI WAS A SYNOVITIS SUPPOSEDLY CAUSED BY A LOOSENING OF THE PROSTHESIS IN PLACE. THE DIAGNOSIS WOULD HAVE BEEN QUALIFIED AS METALLOSIS. THE PATIENT UNDERWENT SURGERY TO REPLACE THE PROSTHESIS. THIS NEW INTERVENTION WAS ALSO PERFORMED IN THE SAME PREVIOUS HOSPITAL AND A NEW PROSTHESIS ALSO FROM J&J WOULD HAVE BEEN PLACED. THE INTERVENING PHYSICIAN IN BOTH SURGERIES WAS THE SAME. ECONOMIC REQUEST: THE PATIENT'S CLAIM IS COMPENSATION FOR DAMAGES CAUSED BY THE REPLACEMENT OF PROSTHESES AND IS (B)(6) PLUS COSTS. THE PATIENT EXPLAINED THAT HIS CLAIM IS MADE UP OF THE ITEMS: MEDICAL AND PHARMACY EXPENSES (PROSTHETICS); PSYCHOPHYSICAL DISABILITY; LOSS OF PROFIT; EMERGENT DAMAGE (PSYCHOLOGICAL TREATMENT); AND MORAL DAMAGE. MEDIATION PROCEDURE: A NEW HEARING DATE WAS SET. THE PATIENT'S ATTORNEY AGREED

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inadequate Osseointegration; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 12672192 ↗
• InjurySep 28, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO FRACTURED FEMUR AND LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. NEEDED TO REMOVE AND REPLACE FEMORAL STEM. DOI: (B)(6) 2021 - DOR: (B)(6) 2021 (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 12539673 ↗
• InjurySep 2, 2021Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS A FEMUR FRACTURE, BUT NOT A DISLOCATION. THERE WAS ABOUT 20 MINUTES SURGICAL DELAY.

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

  MAUDE report 12413381 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO TREAT PAIN, METALLOSIS, ELEVATED SERUM COBALT ION LEVELS, AND INFLAMMATION. ASR HIP - CUP AND HEAD REVISION. STEM LEFT INSTU. DOI: (B)(6) 2008; DOR: (B)(6) 2021; UNKNOWN HIP.

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

  MAUDE report 12189065 ↗
• InjurySep 1, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT INCREASING DISCOMFORT, PATIENT WAS POSITIVE FOR INFECTION. EXPLANT WITH INSERTION OF PROSTALAC. IT WAS ALSO REPORTED THAT THERE WAS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10479749 ↗
• InjuryAug 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES UNBEARABLE PAINS, SQUEAKING NOISE FROM PROSTHETIC JOINT, POWERLESSNESS, DISCOMFORT, ELEVATED METAL IONS IN THE BLOOD AND METALLOSIS. THE MALFUNCTION OF THE MOM PROSTHESIS RESULTED TO HIGHER FRICTION WITH INCREASED TOXIC IONS. DOI: (B)(6) 2008, DOR: (B)(6) 2010, RIGHT HIP.

  Patient problems: Discomfort; Fatigue; Foreign Body Reaction; Loss of Range of Motion; No Code Available; Pain; Test Result

  MAUDE report 10361853 ↗
• InjuryAug 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PROSTHETIC FRACTURE. PLAINTIFF IS SEEKING FULL COMPENSATION FOR ALL THE DAMAGES THAT HAD CAUSED HER SUCH AS PERMANENT BIOLOGICAL INJURY, IMPAIRED MOBILITY, LIMITED ADL, JOINT INSUFFICIENCY, FINANCIAL LOSSES AND SOCIAL INTERACTIONS DUE TO DEFECTIVE AND LACK OF SAFETY PRODUCTS IMPLANTED.

  Patient problems: Bone Fracture(s); Loss of Range of Motion; No Code Available

  MAUDE report 10361760 ↗
• InjuryJul 30, 2020Fracture; Fracture

  PINNACLE LITIGATION RECORD RECEIVED. PATIENT ALLEGES PAIN, FRACTURE OF THE NECK OF THE PROSTHETIC HIP STEM UNDER NORMAL USE, LOSS OF FUNCTION AND GENERAL DEBILITATION OF QUALITY OF LIFE. DOI: (B)(6) 2015 - DOR: (B)(6) 2018 (RIGHT HIP).

  Patient problems: No Code Available; Pain

  MAUDE report 10344823 ↗