CORAIL L20309Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10603295258001), received between Jul 11, 2017 and Nov 25, 2025 — classified as 33 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 35 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE STEM WAS LOOSE AND CAME OUT EASILY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23646855 ↗
• InjuryMay 5, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE LEFT HIP. THERE WAS A FEMORAL STEM LOOSENING DUE TO FRACTURE AT NON-CEMENTED INTERFACE. SURGICAL DELAY WAS UNKNOWN. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 21962051 ↗
• InjuryJun 27, 2024Osseointegration Problem; Osseointegration Problem

  PINNACLE METAL ON METAL MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS ASEPTIC LOOSENING FEMORAL COMPONENT RIGHT THA. OPERATIVE NOTE CONFIRMED FEMORAL COMPONENT WAS GROSSLY LOOSE. METAL HEAD AND LINER WERE REMOVED. HOWEVER, THERE WERE NO METALIC DEBRIS. STEM WAS REVISED AND REPLACED WITH THE PRODIGY SYSTEM. DOI: (B)(6) 2007; DOR: (B)(6) 2011; RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19624439 ↗
• MalfunctionJan 29, 2024Tear, Rip or Hole in Device Packaging; No Apparent Adverse Event; Tear, Rip or Hole in Device Packaging; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PACKAGING WAS DAMAGED UPON RECEIPT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18602951 ↗
• InjurySep 14, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. IT WAS ALSO REPORTED THAT THERE WAS METAL-ON-METAL PINNACLE/ULTAMET LINER OSTEOLYSIS AROUND THE FEMORAL COMPONENT (CORAIL) WITH SUBSEQUENT STEM LOOSENING NEEDING A REVISION SURGERY. DOI: (B)(6) 2011. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Osteolysis

  MAUDE report 17744136 ↗
• InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD (B)(6) 2023. ON (B)(6) 2010, RIGHT HIP ARTHROPLASTY TO ADDRESS AVASCULAR NECROSIS OF THE RIGHT HIP (STICKER PAGE 35 OF 672) INCLUDES A DEPUY PRODUCTS. THE FEMORAL HEAD WAS CERAMIC AND LINER WAS METAL. SURGERY WAS COMPLETED SUCCESSFULLY. (B)(6) 2017 LAB VALUES WERE: COBALT BLOOD 12.0 MCG/L.

  Patient problems: Fatigue; Foreign Body Reaction; Inflammation; Metal Related Pathology; Numbness; Pain

  MAUDE report 17699519 ↗
• InjuryMar 31, 2022Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF ASR CUP AND CORAIL STEM REVISED TO PINNANCLE DUAL AVAILABILITY AND CORAIL REVISED STEM. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT SIDE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13966224 ↗
• InjuryJan 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PC WAS CREATED TO CAPTURED THE LEFT HIP. ON (B)(6) 2011, THE PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY TO ADDRESS LEFT HIP ARTHROPLASTY TO ADDRESS LEFT HIP ARTHRITIS. DEPUY COMPONENTS WERE USED DURING THIS PROCEDURE. NO COMPLICATIONS WERE NOTED DURING THE PROCEDURE. (PART/LOT PAGE 250 OF 302). ON (B)(6) 2018, THE PATIENT HAD A REVISION LEFT TOTAL HIP ARTHROPLASTY, TO ADDRESS FAILED LEFT TOTAL HIP ARTHROPLASTY, WEAR OF ARTICULAR BEARING SURFACE, AND ELEVATED OF SERUM COBALT AND CHROMIUM. THE CERAMIC FEMORAL HEAD AND METAL LINER WERE REVISED. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE ALONG WITH COMPETITOR CEMENT. THE SURGEON REPORTS THAT DUE TO EXCESSIVE ACETABULAR ANTEVERSION, THE PATIENT HAS DEVELOPED ELEVATIONS OF COBALT AND CHROMIUM. THE PATIENT REPORTED EXPERIENCING SUBLUXATION. PRIOR TO SURGERY THE PATIENT HAD AN ASPIRATION, WHICH WAS NOTED TO SUGGEST INFECTION, YET A REPEAT ASPIRATION NEGATED THAT DIAGNOSIS. DURING THE SURGERY, THE SURGEON OBSERVED BLACK SYNOVIAL FLUID (WHICH WAS LATER DIAGNOSED AS METALLOSIS). A SINGLE SCREW WAS LEFT IN PLACE AS THE HEAD HAD STRIPPED, THE REMAINING SCREWS WERE REMOVED. THE CUP WAS LEFT INSITU AS THE SURGEON FELT THEY COULD CORRECT

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

  MAUDE report 13290656 ↗
• InjuryDec 7, 2021Osseointegration Problem; Osseointegration Problem

  REVISION HIP SURGERY DUE TO LOOSE CORAIL COLLARLESS STEM. IT WAS EXTRACTED AND SURGEON USED ANOTHER COMPANY'S SYSTEM. PATIENT STATUS/ OUTCOME / CONSEQUENCES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? REVISION SURGERY 13 YEARS LATER., WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(6), DEVICE PROPERTY OF: HOSPITAL, DEVICE IN POSSESSION OF: NONE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12950702 ↗
• 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 12625262 ↗
• InjuryJul 29, 2020Inadequacy of Device Shape and/or Size; Loss of Osseointegration; Inadequacy of Device Shape and/or Size; Loss of Osseointegration

  REASON FOR REVISION: LOOSE STEM. ON (B)(6) 2020, STEM AND ARTICULEZE HEAD WERE REMOVED AND REPLACED WITH A STEM AND HEAD FROM ANOTHER COMPANY. MARATHON LINER WAS CHANGED, AND ACETABULAR H/E POS STOP SCREW WAS REPLACED WITH A HOLE ELIMINATOR. ORIGINAL OPERATION CONDUCED BY THE SURGEON IN 2006. PATIENT DEMOGRAPHICS. (B)(6) CAUCASIAN MALE. SURGEON STATED STEM WAS UNDERSIZED IN ORIGINAL OPERATION AND HAD BECOME LOOSE. NO INFECTION.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10338887 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PERI PROSTHETIC FEMUR FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 9499103 ↗
• InjuryOct 11, 2019Adverse 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

  IT WAS REPORTED THAT THE PATIENT FELL AND HAD PERIPROSTHETIC HIP FRACTURE. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT HIP.

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

  MAUDE report 9179560 ↗
• InjuryOct 7, 2019Osseointegration Problem; Osseointegration Problem

  PPF ALLEGES LOOSENING OF STEM. MEDICAL RECORDS REPORTED SCARRING AND FEMORAL COMPONENT WAS GROSSLY LOOSE AND REMOVED BY HAND. DOI: (B)(6) 2009; DOR: (B)(6) 2016; (LEFT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 9162753 ↗
• InjuryOct 7, 2019Osseointegration Problem; Osseointegration Problem

  PPF ALLEGES LOOSENING OF STEM. MEDICAL RECORDS REPORTED NECROSIS AND THE FEMORAL STEM WAS GROSSLY LOOSE. DOI: (B)(6) 2009; DOR: (B)(6) 2016 (RIGHT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Necrosis; No Code Available; Pain

  MAUDE report 9162702 ↗
• InjurySep 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF, STICKER SHEETS, AND IMPLANT RECORDS RECEIVED. PPF ALLEGES PULMONARY EMBOLISM AND INFECTION. DOI: (B)(6) 2016, DOR: (B)(6) 2018 (LEFT HIP), DOI: (B)(6) 2008 (STEM).

  Patient problems: No Code Available; Pulmonary Embolism; Unspecified Infection

  MAUDE report 9071194 ↗
• InjurySep 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION RECEIVED. LITIGATION ALLEGES METALLOSIS, METAL DEBRIS, AND SERIOUS BODILY INJURY. LITIGATION HAS ALSO PROVIDED A REVISION DATE OF (B)(6) 2016. AT THIS TIME, WE ARE UNAWARE WHAT PRODUCTS WERE REMOVED. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT WILL BE UPDATED AT THAT TIME. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS. ADDED STEM TO CAPTURE NEW ALLEGATION, LAW FIRM, REVISION HOSPITAL, AFFECTED SIDE, PART, LOT, REGSTAT CODES, MANUFACTURE AND EXPIRATION DATES (HEAD, LINER AND STEM). DOI: (B)(6) 2008; DOR: (B)(6) 2016, (LEFT HIP).

  Patient problems: Injury; No Code Available; Test Result

  MAUDE report 9028703 ↗
• InjuryJul 2, 2019Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION RECEIVED INDICATING THAT THE RIGHT HIP WAS THE AFFECTED SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 8754106 ↗
• InjuryApr 18, 2019Loss of Osseointegration; Loss of Osseointegration

  AFTER REVIEW OF CLAIM AND MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS PAIN, EROSION AROUND THE FEMORAL COMPONENTS, AND LOOSENING OF THE FEMORAL COMPONENTS. REVISION NOTES REPORTED A LOOSE FEMORAL COMPONENT, MILD METAL STAINING WITHIN THE TISSUES, DARK BLOOD-TINGED FLUID, AND SOME MILD AMOUNT OF METALLOSIS. A PEDESTAL WAS ALSO FOUND DURING REAMING AND A DRILL WAS USED TO OPEN IT UP. BONE SCAN CONFIRMED LOOSENING OF THE FEMORAL COMPONENT. RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain; Pocket Erosion; Tissue Damage

  MAUDE report 8526974 ↗
• InjuryApr 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON INFORMED US ABOUT A NEW ASR CLAIM. PATIENT HAS PAIN AND COBALT + CHROME VALUES ARE ABOVE THE LIMITS (CHROME 8.5 MICROGRAM/; COBALT 12.9 MICROGR/L).

  Patient problems: Pain; Test Result

  MAUDE report 8510298 ↗
• InjuryMar 15, 2019Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES PAIN, INJURY AND EMOTIONAL DISTRESS. DOI: (B)(6) 2008; DOR: (B)(6) 2016; RIGHT HIP. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES PSEUDOTUMOR AND INFECTION. PPF ALLEGES STEM LOOSENING AND PFS ALLEGES LIMITED MOBILITY.

  Patient problems: Inadequate Osseointegration; Injury; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Unspecified Infection

  MAUDE report 8425605 ↗
• InjuryMar 4, 2019Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  THE STEM WOULD NOT COME OUT WITH JUST THE SLAP HAMMER. HE BEAT IT UNTIL HE BROKE OUR SLAPPER AND A COMPETITORS HAMMER. WHEN HE WINDOWED THE DISTAL FEMUR ( THE STEM IS FULLY COATED HA) A COUPLE OF TAPS WITH THE TAMP IT CAME OUT EASILY. WHAT I SHOULD HAVE SAID IS THAT WHEN HE LOOSENED IT UP DISTALLY IT CAME OUT EASY. SORRY FOR THE CONFUSION.

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

  MAUDE report 8387540 ↗
• InjuryFeb 12, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  LITIGATION PAPERS ALLEGE FOLLOWING THE SURGERY, PATIENT EXPERIENCED PAIN AND EXTREME WEAKNESS IN HIS HIP AND QUADRICEPS. UPDATE (B)(6) 2013 - THE COMPLAINT HAS BEEN UPDATED BECAUSE THE PATIENT'S RIGHT HIP WAS REVISED ON (B)(6) 2013 TO ADDRESS PAIN, INFECTION, SIGNIFICANT METALLOSIS, AND CYSTS. UPDATE AD 25 JUN 2018 THE RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED. PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2010; DOR: (B)(6) 2014; (RIGHT HIP).

  Patient problems: Cyst(s); No Code Available; Pain; Test Result; Tissue Damage; Unspecified Infection; Weakness

  MAUDE report 8331219 ↗
• InjuryJan 8, 2019Biocompatibility; Biocompatibility

  LITIGATION ALLEGES THAT PATIENT HAS EXPERIENCED SEVERE PAIN. ADDITIONALLY, IT IS ALLEGED THAT TOXIC AMOUNTS OF COBALT AND CHROMIUM ARE MAKING THEIR WAY INTO PATIENT'S HIP JOINT AND BLOOD STREAM. UPDATE AD 27 JUNE 2018 RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF THE STEM AND ELEVATED METAL IONS. ADDED STEM DUE TO THE ALLEGATION.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain; Test Result

  MAUDE report 8226136 ↗
• InjuryDec 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2009 - DOR: (B)(6) 2014 (RIGHT HIP).

  Patient problems: Test Result

  MAUDE report 8183946 ↗