CORAIL 3L93712Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10603295168898), received between Jul 21, 2017 and Dec 1, 2025 — classified as 1 death, 50 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (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. 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.

• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23685766 ↗
• MalfunctionFeb 26, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THERE WAS DAMAGE TO PLASTIC PACKAGING ON PRODUCT. OUTER PACKAGING WITHOUT DAMAGE. NO IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21472179 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY DUE TO DEGENERATIVE JOINT DISEASE. ON (B)(6) 2023, PATIENT UNDERWENT A REVISION DUE TO PAIN AND LOSS OF FUNCTION SECONDARY TO METALLOSIS.

  Patient problems: Foreign Body Reaction; Loss of Range of Motion; Pain

  MAUDE report 20338977 ↗
• InjuryJun 7, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE EXTRACTION OF TOTAL HIP IMPLANTS WAS PERFORMED DUE TO LOOSENING. DOI: (B)(6) 2021 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19492401 ↗
• InjuryOct 2, 2023Osseointegration Problem; Osseointegration Problem

  REVISION OF CORAIL STEM DUE TO LOOSENING. THE SURGEON BELIEVES THAT THE STEM WAS INITIALLY OVERSIZED, POTTED DISTALLY WITHOUT FULLY SEATING PROXIMALLY, AND EVENTUALLY CAME LOOSE. A STEM ONLY REVISION SURGERY WAS PERFORMED. STEM AND HEAD WERE REMOVED. DOI: (B)(6) 2019. DOE: (B)(6) 2023. AFFECTED SIDE: RIGHT.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 17851448 ↗
• InjuryFeb 13, 2023Osseointegration Problem; Osseointegration Problem

  LOOSE STEM AND ACETABULAR IMPLANTS DUE TO SUSPECTED INFECTION, ALL IMPLANTS REMOVED AND TEMPORARY CEMENT SPACER IMPLANTED, THIS WILL STAY IN PLACE UNTIL INFECTION HAS BEEN TREATED, SECOND STAGE REVISION WILL THEN TAKE PLACE. PRIMARY OPERATION WAS DONE ON (B)(6) 2021. DOR: (B)(6) 2023.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 16366952 ↗
• InjuryDec 14, 2022Osseointegration Problem; Osseointegration Problem

  CORAIL LOSENING. UNNDERSIZING ? FIRST IMPLANTATION 2019.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15978165 ↗
• InjuryAug 29, 2022Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSE FEMORAL STEM. THE LOOSENING IS NON CEMENTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2018 DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15313221 ↗
• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON HAD REMOVED IMPLANTS FOR INFECTION AT BRISBANE PRIVATE HOSPITAL. DR [SURGEON NAME] DOES NOT REQUIRE ANY CONTACT AS REMOVAL WAS FOR INFECTION ONLY. ORIGINAL SURGERY WAS DONE IN 2020. ORIGINAL SURGERY SURGEON WAS DR [SURGEON NAME]. ORIGINAL SURGERY HOSPITAL WAS AT (B)(6) HOSPITAL.

  Patient problems: Unspecified Infection

  MAUDE report 15214697 ↗
• InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2021 (CUP, SCREWS, STEM), DOI: (B)(6) 2021(HEAD, LINER), DOR: FEB 21, 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13693393 ↗
• InjuryOct 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 12563141 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO 2ND STAGE IMPLANTATION BECAUSE OF INFECTION. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF THE UNKNOWN COMPONENT AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2019, DOR: (B)(6) 2021, (LEFT HIP).

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

  MAUDE report 12540307 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN - DOR: (B)(6) 2021 (RIGHT HIP).

  Patient problems: Pain

  MAUDE report 12211221 ↗
• InjuryJun 15, 2021Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF HIP PAIN. XRAYS WERE OBTAINED AND SHOWN TO BE A ASR CUP THAT HAS BEEN RECALLED. A BLOOD TEST WAS COMPLETED AND SHOWN TO HAVE HIGH METAL IONS IN HIS BLOOD WORK. A MRI AND CT WERE ORDERED TO SHOW HE HAD A PSEUDO TUMOR. INTRA-OP WOULD INDICATE THAT WAS TRUE. THERE WAS METALOSIS, AND BLACKENING OF TISSUE IN HIS HIP. CULTURES AND SPECIMEN WERE SENT OFF FOR FURTHER TESTING. THE CUP WAS REMOVED, THE HIP WAS DEBRIDED, IRRIGATED AND A NEW CUP WAS PLACED. AFTER TRIALING USING A 40 MM HEAD AND POLY IT WAS DETERMINED THIS PATIENT HAD A STABLE HIP WITH FULL RANGE OF MOTION. CATALOG AND LOT NUMBERS ARE NOT AVAILABLE DUE TO AN UPGRADE IN THE HOSPITALS SOFTWARE. NO OP REPORT WAS AVAILABLE. THE ORIGINAL SURGEON THAT DID THE PRIMARY HAS PAST AWAY SEVERAL YEARS AGO. NO OTHER INFORMATION IS AVAILABLE FROM WHAT HAS BEEN STATED. DOI: (B)(6) 2009 - DOR: (B)(6) 2021 (LEFT HIP).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement; Discomfort; Distress; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Metal Related Pathology; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 12000512 ↗
• InjuryApr 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED A REVISION DUE TO METALLOSIS AND METAL POISONING. THE HIP BONE AND SURROUNDING MUSCLE HAD SEVERE DEGENERATION DUE TO THE ELEVATED IONS. THE SUP, HEAD AND LINER WERE REVISED. THE STEM WAS RETAINED. DOI: (B)(6) 2009, DOR: (B)(6) 2020 (HEAD), DOR: (B)(6) 2020 (CUP, HEAD, STEM), LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Unspecified Tissue Injury

  MAUDE report 11612921 ↗
• InjuryMar 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2021; DOR: (B)(6) 2021; AFFECTED SIDE: LEFT HIP.

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

  MAUDE report 11574839 ↗
• InjuryJan 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR TROCHANTERIC BURSITIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2019, DATE OF EVENT: (B)(6) 2021, (LEFT HIP).

  Patient problems: Inflammation; Pain

  MAUDE report 11195898 ↗
• MalfunctionSep 10, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE IMPLANT WAS TOO BIG FOR ITS BROACH. COULD NOT FIT INSIDE THE FEMUR. HAD TO USE ANOTHER IMPLANT OF SAME SIZE.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 10515797 ↗
• MalfunctionJul 16, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IMPLANTS WERE RETURNED DUE TO WET PACKAGING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10283960 ↗
• InjuryMay 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION CASE OF AN INFECTED CORAIL PINNACLE. IN SPEAKING WITH THE SURGEON BEFORE THE REVISION PROCEDURE, HE ADVISED THAT THE PATIENT HAD PRIMARY THR IN FEBRUARY THIS YEAR AND HAS PRESENTED TO ED WITH A DISSOCIATED ACETABULAR LINER AND INFECTED HIP. SURGEON UNABLE TO SAY WHY HE THOUGHT THE PATIENT HAD A DISSOCIATED LINER BUT DID MENTION THE PATIENT REPORTING A FALL AT SOME STAGE. REVISED HIP TO ZB-G7 DUAL MOBILITY CUP AND C-STEM (ATTACHMENT INCLUDED WITH PRODUCT USAGE FROM REVISION CASE COMPLETED TODAY). REVISION SURGERY WENT AS PLANNED. EXPLANTED PRODUCTS NOT AVAILABLE AS RETAINED BY HOSPITAL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Fall; Foreign Body Reaction; No Code Available; Unspecified Infection

  MAUDE report 10088019 ↗
• InjuryMay 14, 2020Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  PCF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, NO REVISION NOTES REPORTED. PATIENT ALLEGES CHRONIC PAIN, STIFFNESS, WALKING DIFFICULTY, SWELLING, DIFFICULTY IN WEARING SHOES AND SOCKS, DIFFICULTY WITH STAIRS, PAINFUL ANTALGIC GAIT, LIMP, ARTHRALGIAS, JOINT SWELLING, AND MYALGIAS. PHYSICAL EXAM STATED DECREASED STRENGTH, TENDERNESS, BONY TENDERNESS, SWELLING, AND CREPITUS. LABORATORY RESULTS STATED ELEVATED METAL IONS. DOI: (B)(6) 2008. DOR: NONE REPORTED; (LEFT HIP). PATIENT IS BILATERAL. SEE (B)(4) FOR THE RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Edema; Limited Mobility Of The Implanted Joint; Muscular Rigidity; No Code Available; Pain; Test Result

  MAUDE report 10055968 ↗
• InjuryMay 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS' HIP WAS INFECTED. THE HIP HEMI CONSTRUCT WAS REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED. DOI: (B)(6) 2020; RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10019022 ↗
• InjuryMar 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT PATIENT EXPERIENCED PAIN, WEAKNESS, DIFFICULTY WITH SIMPLE DAILY LIVING ACTIVITIES, INABILITY TO RETURN TO WORK, AND INCREASED METALLIC IONS IN HIS BLOODSTREAM. REVISION OPERATIVE NOTE REVIEWED AND CONFIRMED METALLOSIS. THE REVISION OPERATIVE NOTE ALSO MENTIONS ALVAL. IN ADDITION TO WHAT PREVIOUSLY ALLEGED, LITIGATION ALLEGED METAL WEAR, SKIN RASHES, WEIGHT LOSS, PAIN, INCREASE INCIDENCE OF ATRIAL FIBRILLATION, ANXIETY, THIRST, LOOSE OF TASTE, METALLIC TASTE IN SALIVA, AND DRY FRAGILE SKIN. AFTER REVIEW OF MEDICAL RECORDS IT WAS INDICATED THAT THE PATIENT PRESENT WITH PROGRESSIVE WORSENING LEFT HIP PAIN, DEMONSTRATED ELEVATED METAL IONS. THE PATIENT WAS THEN REVISED FOR PAINFUL METAL-SENSITIVITY REACTION TO NECROSIS (ALVAL). OPERATIVE NOTES REPORTED THAT THE CUP WAS LITTLE GENEROUSLY ANTEVERTED AND THERE WAS SOME EROSIVE DEFICIENCY NOTED OF THE ANTERIOR ACETABULAR BONY WALL, DUE TO INFLAMMATORY PROCESS.

  Patient problems: Anxiety; Atrial Fibrillation; Discomfort; Foreign Body Reaction; No Code Available; Polydipsia; Rash; Weakness

  MAUDE report 9899654 ↗
• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. SWAPPED LINER LEFT CUP. DOI: (B)(6) 2017; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 9811835 ↗
• InjuryFeb 25, 2020Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  CLINICAL ADVERSE EVENT RECEIVED FOR STEM ROTATION CAUSING PAIN : MALPOSITION/ NON-UNION TROCHANTER. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY THAT THE EVENT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT HIP).

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

  MAUDE report 9751743 ↗