CORAIL 3L92505Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295168713), received between Jul 26, 2017 and Apr 17, 2026 — classified as 24 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (4 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REMOVED COMPONENTS DUE TO FX, DISLOCATION, AND NON COMPLIANCE. DOI- (B)(6) 2026. DOR-UNKNOWN. AFFECTED SIDE-RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 24915200 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL DUE TO INFECTION. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23367209 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVISION AND COMPONENTS WERE REVISED DUE TO INFECTION. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22292695 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED INFECTION APPROXIMATELY TWO MONTHS POSTOP. THEY REMOVED ALL COMPONENTS AND IMPLANTED CEMENT SPACERS. DOI: UNKNOWN. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21160044 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 18371831 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2022. DOR- (B)(6) 2023. AFFECTED SIDE- LEFT HIP.

  Patient problems: Pain

  MAUDE report 17967252 ↗
• MalfunctionDec 9, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PRODUCT WAS RECEIVED DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15950340 ↗
• MalfunctionJul 18, 2022Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE CORAIL AMT STEM. THE SURGEON COMPLAINED REGARDING THE STYROFOAM ATTACHED TO THE NECK OF THE STEM AS PROTECTION. THE STYROFOAM WAS ATTACHED FIRMLY THAT IT COULD NOT BE EASILY REMOVED BY HAND AND IS DIFFICULT TO REMOVE. IN ADDITION, IT IS DIFFICULT TO REMOVE THE NECK WHEN THE SURGEON¿S HAND IS SLIPPERY DURING SURGERY, AND THERE IS A RISK OF DAMAGING THE NECK PART WHEN PICKING IT UP WITH A COCKEREL AND OTHER INSTRUMENTS. THEREFORE, THE SURGEON ASKED THE SALES REP TO IMPROVE ALL THE IMPLANTS PROTECTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15045034 ↗
• InjuryAug 24, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. THE PATIENT COMPLAINS OF PAIN IN THE FEMUR. XRAYS SHOW STEM WELL-FIXED DISTALLY, BUT LUCENT LINES PROXIMALLY INDICATING LOOSE STEM. PATIENT WAS TAKEN TO OR TO FIND STEM LOOSE PROXIMALLY AND WELL-FIXED DISTALLY. AN OSTEOTOMY WAS REQUIRED TO REMOVE AFTER SEVERAL FAILED ATTEMPTS TO REMOVE FROM ABOVE. FROZEN SECTION DID NOT SHOW SIGNS OF INFECTION. SURGEON ALSO CHOOSE TO CONVERT TO DUAL MOBILITY CONSTRUCT TO ENHANCE STABILITY DUE TO INCREASED RISK AFTER REVISION PROCEDURE. DOI: (B)(6) 2020, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12362097 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE HIP STEM WAS LOOSE AND LOOSENING WAS DUE TO INFECTION.

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

  MAUDE report 11709900 ↗
• InjuryApr 7, 2021Degraded; Degraded

  22 MAR 2021. MEDICAL RECORD REVIEWED. MEDICAL RECORDS RECEIVED WERE REVIEWED TO IDENTIFY PATIENT HARMS/PRODUCT ISSUES. ON (B)(6) 2020, THE PATIENT UNDERWENT A RIGHT HIP REVISION TO ADDRESS OSTEOLYSIS, ELEVATED METAL LEVELS (VALUES NOT GIVEN), EARLY PSEUDOTUMOR, AND LIMB ASYMMETRY. THE SURGEON NOTED SYNOVITIS AND REACTIVE CHANGE IN THE SOFT TISSUE, AS WELL AS GRAY DISCOLORATION CONSISTENT WITH METAL DEBRIS. THE TRUNNION WAS CLEANED WITH A SCRATCH PAD TO CLEAR ALL CORROSION. MASSIVE OSTEOLYSIS WAS NOTED AROUND THE FEMUR, HOWEVER, THE FEMUR WAS VERY WELL INTACT AND RETAINED ALONG WITH THE CUP. THE HEAD AND LINER WERE REVISED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. TASK CREATED TO UPDATE PC.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hypersensitivity/Allergic reaction; Osteolysis; Physical Asymmetry; Synovitis

  MAUDE report 11631645 ↗
• InjuryNov 6, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT RECENTLY HAD SURGERY AND DEVELOPED AN INFECTION SHORTLY AFTER. SHE CAME BACK IN FOR AN I&D, POTENTIAL POLY/HEAD SWAP. UPON OPENING THE JOINT AND TRYING TO REMOVE THE HEAD THE STEM BECAME LOOSE AT BONE TO IMPLANT INTERFACE. AT THIS POINT THE SURGEON DECIDED TO REMOVE ALL IMPLANTS AND PUT A TEMPORARY SPACER UNTIL THE INFECTION CLEARS. DOI: (B)(6) 2020 - DOR: (B)(6) 2020 (LEFT HIP).

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

  MAUDE report 10801912 ↗
• InjuryJul 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FEMUR FRACTURED AND DISLOCATED SO THE DOCTOR REPLACES HEAD AND STEM WITH NEW REVISION STEM AND HEAD. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT SIDE.

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

  MAUDE report 10295861 ↗
• InjuryOct 22, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC FRACTURE AFTER A FALL AND LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9218036 ↗
• InjuryJul 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2019; DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8807066 ↗
• InjuryJun 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED THAT THE SURGERY DATE WAS UNKNOWN AND THE AFFECTED SIDE INVOLVED WAS THE LEFT SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8708725 ↗
• InjuryJun 7, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT WAS PRESENTED WITH A PAINFUL HIP. SURGEON REMOVED A LOOSE CORAIL STEM, CUP WAS WELL FIXED. SURGEON REPLACED STEM AND CHANGED LINER WHILE IN SITU. DOI: (B)(6) 2012, DOR: (B)(6) 2019, LEFT SIDE.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8678950 ↗
• InjuryMay 23, 2019Corroded; Corroded

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL HIP TO ADDRESS ADVERSE LOCAL TISSUE REACTION (ALTR). DOI: (B)(6) 2008; DOR: (B)(6) 2019, (RIGHT HIP).

  Patient problems: No Code Available; Osteolysis; Pain; Tissue Damage

  MAUDE report 8636930 ↗
• InjuryMay 16, 2019Fracture; Fracture

  CORAIL STEM BREAKAGE. PATIENT WEIGHT: (B)(6); PRIMARY SURGERY IN 2016; STEM SIZE: 15; X-RAY UPLOADED TO ECM.

  Patient problems: No Code Available

  MAUDE report 8616959 ↗
• InjuryMar 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS CONFIRMED FOR INFECTION. ALL HIP HEMI IMPLANTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8404732 ↗
• InjuryDec 28, 2018Biocompatibility; Biocompatibility

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM HIGHLY ELEVATED BLOOD METAL LEVELS, PAIN, POPPING, SQUEAKING AND DIFFICULTY AMBULATING. UPDATE AD 07 MAY 2018 RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS.

  Patient problems: Pain; Test Result; Tissue Damage

  MAUDE report 8202306 ↗
• InjuryDec 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. THIS IS A CLINICAL PATIENT, REPORT STATES THAT THE PATIENT HAD METALLOSIS, AND PSEUDOTUMOR. UPDATE PPF ALLEGES PSEUDOTUMOR AND ELEVATED METAL IONS. DOI: (B)(6) 2008 - DOR: (B)(6) 2012 (RIGHT HIP).

  Patient problems: No Code Available; Test Result

  MAUDE report 8125282 ↗
• MalfunctionNov 2, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TWO PIECE STEM INSERTER, WHICH THREADS INTO STEM, COULD NOT UN-THREAD ONCE THE STEM WAS IMPACTED. WHEN THE STEM WAS EXTRACTED, IT WAS NOT POSSIBLE TO REMOVE THE STEM FROM THE INSERTER.

  Patient problems: Not Applicable

  MAUDE report 8034193 ↗
• InjurySep 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND IMPLANT RECORDS RECEIVED. PPF ALLEGED ELEVATED METAL IONS AFTER FIRST REVISION. DOI: (B)(6) 2013 - DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Test Result

  MAUDE report 7905264 ↗
• InjuryJul 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS ELEVATED METAL IONS AND PAIN. DOI: 2009; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Pain

  MAUDE report 7710279 ↗