CORAIL 3L92512Recalls & reported problems

Summary

The FDA's MAUDE database contains 135 adverse event reports that list this exact device (DI 10603295168782), received between Jan 29, 2015 and Apr 17, 2026 — classified as 117 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (16 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 135 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2026Osseointegration Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO POTTING OF THE STEM. USED WATSON EXTRACTION TO EXPLANT THE STEM AND REPLACED THE LINER. USED STRYKER RESTOMOD STEM AND HEAD. IT WAS STATED THAT CORAIL STEM WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS BONE TO IMPLANT. DOI: (B)(6) 2018. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24911808 ↗
• MalfunctionFeb 13, 2026Tear, Rip or Hole in Device Packaging

  INTRAOPERATIVELY - DAMAGE TO THE PACKAGING AND THE DRILL BIT IS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337204 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 23833830 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO PAIN IN THE LEFT HIP WITH A HEAD PROSTHESIS DUE METAL-ON-METAL BEARING ELEMENTS CAUSING PAIN, METALLOSIS, NECROSIS, SYNOVIALITIS AND ELEVATED COBALT AND CHROMIUM IN BLOOD AND URINE WITH OSTEOLYSIS IN PELVIS AND FEMUR. DURING SURGERY, IT WAS NOTED THAT THE INNER CAPSULE SHOWED PRONOUNCED SYNOVIAL INFLAMMATION. FLUOROSCOPY SHOWED SUPERIOR OSTEOLYSIS UP TO 1 CM THICK. OSTEOLYSIS OF ANTERIOR COLUMN CONSISTENT WITH IMAGING WAS ALSO OBSERVED ALONG WITH LARGE BONY DEFECT FOUND MEDIALLY, CONSISTENT WITH IMAGING. AFFECTED SIDE: LEFT HIP.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Necrosis; Osteolysis; Pain; Synovitis; Unspecified Musculoskeletal problem

  MAUDE report 23369652 ↗
• InjuryMay 30, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6) 2025 DUE PAIN AND ASEPTIC LOOSENING OF THE FEMORAL STEM.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 22118060 ↗
• InjuryMar 20, 2025Migration; Migration

  IT WAS REPORTED THAT THERE WAS PROSTHETIC STEM MOBILIZATION POST-IMPLANT. PATIENT UNDERWENT REVISION.

  Patient problems: Insufficient Information

  MAUDE report 21654507 ↗
• InjurySep 24, 2024Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL STEM CAUSED BY PERIPROSTHETIC FRACTURE AT THE NON-CEMENTED INTERFACE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 20292454 ↗
• InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT IS EXPERIENCING HIGH CO IONS LEVELS 136. HYPERCOBALTEMIA DOI: ON (B)(6) 2008, DOE: ON (B)(6) 2024.

  Patient problems: Metal Related Pathology

  MAUDE report 19801154 ↗
• InjuryJun 25, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE CORAIL PINNACLE WAS REVISED DUE TO METALOSSIS. DOI: 2008. DOE: (B)(6) 2024. AFFECTED SIDE:LEFT.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration

  MAUDE report 19605350 ↗
• InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT EMAILED DESCRIBING EVENT DETAILS. MEDICAL RECORDS UPLOADED FROM (B)(6) 2024 WERE REVIEWED BY CLINICIAN. ON (B)(6) 2019, THE PATIENT HAD A TOTAL RIGHT HIP ARTHROPLASTY. DEPUY CORAIL SIZE 12 STEM, 52 MM CUP, +1.5 NECK, 36 CERAMIC HEAD ON POLY WERE IMPLANTED. ON (B)(6) 2024, THE PATIENT HAD A REVISION RIGHT TOTAL HIP, TO ADDRESS ACETABULAR LINER FRACTURE, DISASSOCIATION OF THE CUP/LINER, METALLOSIS, WEAR OF THE ACETABULAR CUP. PRIOR TO SURGERY, THE PATIENT WAS NOTED TO HAVE EXPERIENCED PAIN, FEELING A CLUNKING/SQUEAKING SENSATION IN THEIR HIP. THE FEMORAL STEM WAS FOUND TO BE GROSSLY STABLE AND RETAINED. PATIENT REPORTED THAT SIGNIFICANT DAMAGE TO THE PELVIC BONE. DEPUY FEMORAL HEAD ALONG WITH COMPETITOR ACETABULAR COMPONENTS WERE IMPLANTED. PATHOLOGY NOTES THE ACETABULAR COMPONENT REMOVED ((B)(6) 2024) HAD 9207324 INSCRIBED ON RIM, A COMPONENT WITH 122136052 D36N52, A COMPONENT WITH D1246-0 AND D1906.

  Patient problems: Ambulation or Postural Difficulties; Distress; Foreign Body Reaction; Pain; Unspecified Tissue Injury

  MAUDE report 19584374 ↗
• MalfunctionMay 30, 2024Wrong Label; Wrong Label

  FOLLOWING A VERIFICATION CHECK OF THE CORRECT STEM IMPLANT REQUIRED DURING A TOTAL HIP REPLACEMENT SURGERY, THE THEATRE NURSING TEAM REMOVED THE PLASTIC PACKAGING FROM A CORAIL NON COLLARED STEM IMPLANT BOX AND AFTER OPENING THE BOX, DISCOVERED THAT THE IMPLANT STICKERS ADHERED TO THE BOX INSIDE WERE FOR AN ACTIS HIGH OFFSET IMPLANT. THIS WAS DISCOVERED AT THE ROUTINE IMPLANT CHECK STAGE. THE IMPLANT WAS NOT OPENED, THE PACKAGING AND STICKERS WERE REMOVED FROM THE THEATRE AND A SECOND CORAIL NON COLLARED STEM OF THE SAME SIZE WAS OPENED. THIS CORAIL STEM HAD THE CORRECT STICKERS ADHERED TO THE BOX INSIDE AND WAS USED BY THE SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19423422 ↗
• InjuryMay 24, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION DUE TO METALLOSIS AND PSEUODOTUMOR.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction

  MAUDE report 19392309 ↗
• InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE RECEIVED: ON (B)(6) 2009, THE PATIENT HAD AN OPEN ARTHROTOMY OF THE RIGHT HIP ARTHROPLASTY TO ADDRESS SEVERE DEGENERATIVE ARTHRITIS OF THE RIGHT HIP. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. ON (B)(6) 2024, THE PATIENT HAD A RIGHT HIP REVISION. DOI: (B)(6) 2009. DOE: (B)(6) 2024. RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Pain; Physical Asymmetry

  MAUDE report 19299039 ↗
• InjuryFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR XL COMPLAINT RECEIVED AD (B)(6) 2024. PATIENT UNDERWENT REVISION DUE TO PAIN. DOI: (B)(6) 2009. DOR: (B)(6) 2024. RIGHT HIP.

  Patient problems: Pain

  MAUDE report 18787155 ↗
• 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 18603001 ↗
• InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT LEFT ASR XL REVISION DUE TO PAIN. DOI: (B)(6) 2009. DOR: (B)(6) 2023. LEFT HIP.

  Patient problems: Pain

  MAUDE report 18283470 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CAME IN WITH A PERI PROSTHETIC FRACTURE OF A CORAIL/PINNACLE. THE STEM AND HEAD REMOVED AND REPLACED THE CONSTRUCT WITH A RECLAIM. AFTER REAMING TO AN APPROPRIATE DEPTH AND PLACING CABLES THE PATIENT WAS STABLE AND LEG LENGTH WAS APPROPRIATE. DOI- UNKNOWN; DOR- (B)(6) 2023; AFFECTED SIDE- RIGHT HIP.

  Patient problems: Joint Laxity; Limb Fracture; Physical Asymmetry

  MAUDE report 17309623 ↗
• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. ON (B)(6) 2013 DISCHARGE NOTES THE PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY, WHICH INCLUDED USING ZIMMER (COMPETITOR) GRIPTION AND ? SYSTEM. OPERATIVE NOTES STATE THE PATIENT HAD SEVERE DEGENERATIVE JOINT DISEASE OF THE LEFT HIP WITH PARTIAL DISLOCATION. DEPUY PRODUCTS WERE USED. THERE WAS NO MENTION OF COMPETITOR PRODUCTS IMPLANTED IN THE ACTUAL OPERATIVE NOTE. ON (B)(6) 2016 THE PATIENT HAD A HIP REDUCTION TO ADDRESS THE LEFT HIP POST-REDUCTION OF SUBLUXATION (DISLOCATION). (THIS WAS CAPTURED IN (B)(4)). IT WAS NOTED THAT RADIOGRAPHS SHOWED OSTEOPENIA IS PRESENT. ON (B)(6) 2016 THE PATIENT WAS NOTED TO HAVE LEFT HIP DISLOCATION AND A HIP REDUCTION WAS COMPLETED.

  Patient problems: Foreign Body Reaction

  MAUDE report 17108698 ↗
• MalfunctionJun 12, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A HAIR WAS TRAPPED IN THE IMPLANT PACKAGING. A DIFFERENT STEM WAS THEN OPENED AND IMPLANTED INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17108021 ↗
• InjuryMay 23, 2023Degraded; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Degraded; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES METAL POISONING FROM TOXIC HEAVY METALS AND REQUIRED TO UNDERGO SURGICAL REMOVAL OF THE DEFECTIVE SYSTEM. PLAINTIFF SUFFERED INJURIES INCLUDING PAIN, INJURY, METALLOSIS, METAL WEAR, METAL POISONING, LOSS OF ENJOYMENT OF LIFE AND LIMITATION OF DAILY ACTIVITIES. DOI: (B)(6)2012. DOR: (B)(6)2022. SIDE: RIGHT HIP.

  Patient problems: Distress; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Metal Related Pathology; Muscle/Tendon Damage; Necrosis; Pain

  MAUDE report 16988698 ↗
• InjuryMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR XL LEGAL RECEIVED. PATIENT WAS REVISED DUE TO PAIN, METALLOSIS AND LOOSENING OF ACETABULAR SIDE. DOI: (B)(6) 2008; DOR: (B)(6) 2023; LEFT HIP.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 16894371 ↗
• InjuryApr 10, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THE PATIENT DEVELOPED ASEPTIC LOOSENING OF HIP PROSTHESIS, NO PRIOR ALLERGIC HISTORY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16708897 ↗
• MalfunctionFeb 17, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THAT A CUSTOMER AT (B)(6) MADE US AWARE THAT ONE OF THEIR CORAIL STEMS (WHICH SHOULD HAVE A GREEN LABEL) HAS A BLUE LABEL. WE¿RE NOT SURE IF THIS IS A PRINTER INK ERROR, OR WHY THIS IS ¿ BUT IT IS INCORRECT & COULD CAUSE AN ISSUE IF IT GETS MISTAKEN FOR A STEM WHICH SHOULD HAVE A BLUE LABEL.

  Patient problems: Insufficient Information

  MAUDE report 16395969 ↗
• MalfunctionJan 30, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PIECE OF HAIR WAS FOUND INSIDE THE PRODUCT PACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16263798 ↗
• InjuryJan 24, 2023Osseointegration Problem; Osseointegration Problem

  REVISION OF A CORAIL STEM. THE REASON FOR REVISION WAS DUE TO LOOSENING. THE STEM WAS UNDERSIZED AND WAS DISTALLY LOADED RESULTING IN LOOSENING. THE PRIMARY SURGERY WAS DONE ABOUT 10 YEARS AGO. THE METAL HEAD WAS REMOVED TOO. CUP AND LINER WERE NOT REVISED. CORAIL REVISION STEM WAS IMPLANTED. DOI: UNKNOWN. DOR: (B)(6) 2023. UNKNOWN SIDE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16233334 ↗