CORAIL 3L92502Recalls & reported problems

Summary

The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 10603295168683), received between Jul 21, 2017 and Apr 17, 2026 — classified as 115 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (17 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 126 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 DISLOCATION/FRACTURE DUE TO FALL. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT.

  Patient problems: Fall; Limb Fracture

  MAUDE report 24914188 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 23679411 ↗
• MalfunctionAug 8, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT ¿ CAN YOU PLEASE CLARIFY WHAT DO YOU MEAN BY ¿DAMAGED¿? WAS IT WORN, CRACKED, BROKEN INTO PIECES, BENT, STRIPPED, CROSS THREADED OR ANY DEVICE INTERACTION. ¿ WAS THE PROCEDURE COMPLETED SUCCESSFULLY? YES, OTHER STOCK AVAILABLE. ¿ WAS THERE AN ALTERNATE IMPLANT AVAILABLE TO COMPLETE THE PROCEDURE? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22749912 ↗
• InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BROKE THEIR FEMUR DISTAL TO STEM. STEM/HEAD/LINER WERE REMOVED AND LPS PROX FEMUR CONSTRUCT WERE IMPLANTED. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 22045758 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AT HOME AND FRACTURED THE FEMUR AROUND THE IMPLANT. THE PATIENT UNDERWENT A REVISION PROCEDURE. THERE WAS NO SURGICAL DELAY. THERE WERE NO ALLEGATIONS AGAINST THE LINER, IT WAS ONLY REVISED TO CONVERT TO A CONSTRAINED LINER. DOI: (B)(6) 2019, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 21777851 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. EVERYTHING WAS REMOVED, PROSTALAC STEM AND HEAD WERE PUT IN. ALSO, A LINER WAS CEMENTED IN AS A STAGE 1 REVISION. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21453254 ↗
• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 21263561 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION OF THE LEFT HIP OCCURRED ON SEPTEMBER 30, 2024 DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. ORIGINAL IMPLANT DATE WAS (B)(6) 2016

  Patient problems: Unspecified Infection

  MAUDE report 20358298 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 20231360 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN , DOR: (B)(6) 2024, AFFECTED SIDE : UNKNOWN.

  Patient problems: Pain

  MAUDE report 20226757 ↗
• InjurySep 9, 2024Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF 12KA CORAIL STEM AT THE NON CEMENTED INTERFACE. DOI: UNKNOWN DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20169248 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC OSTEOLYSIS OF THE FEMUR ACETABULUM, TOXIC EFFECT OF CHROMIUM, TROCHANTERIC NONUNION, LEG LENGTH DISCREPANCY, PSEUDOTUMOR AND HIP PAIN. OPERATIVE NOTE REPORTED A LARGE FLUID COLLECTION FROM BENEATH FASCIA THIS WAS BLOOD TINGED BUT WAS CLEAR. THERE WAS A LOT OF NECROTIC TISSUES, SCAR TISSUES AND A MASS AROUND TROCHANTERIC NONUNION. THERE WAS A MINIMAL BONE LOSS. THERE WAS A NECROTIC TISSUE IN THE ACETABULUM THAT WAS SLIGHTLY VERTICAL AND WAS DEFICIENT POSTERIOR SUPERIORLY. DOI: (B)(6) 2006. DOR: (B)(6) 2024. RIGHT HIP.

  Patient problems: Adhesion(s); Foreign Body Reaction; Hypersensitivity/Allergic reaction; Metal Related Pathology; Necrosis; Nonunion/Delayed-union Bone Fracture; Osteolysis; Pain; Physical Asymmetry; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 19920111 ↗
• InjuryMay 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE METAL ON METAL LITIGATION FORM RECEIVED. THE PATIENT HAD A HIP REVISION DUE TO OSTEOLYSIS AND ELEVATED METAL ION LEVELS. DOI: (B)(6) 2010 DOR: (B)(6) 2022 RIGHT HIP.

  Patient problems: Metal Related Pathology; Osteolysis

  MAUDE report 19432070 ↗
• MalfunctionMay 9, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PRODUCT PACKAGE IS DAMAGED. IN PICTURES LOOKS LIKE SHIPPING BOX IS FINE, PRODUCT PACKAGE DAMAGED.

  Patient problems: Insufficient Information

  MAUDE report 19276944 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FEMORAL COMPONENT WAS REPLACED WITH REVISION STEM DUE TO PERIPROSTHETIC FRACTURE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 18856368 ↗
• InjuryJan 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON STATED THAT THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18535381 ↗
• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF HAS NO ALLEGATION AND NO REVISION REPORTED. ALL THE IMPLANTED DEVICE DURING THE INITIAL IMPLANTATION WERE REPORTED TO THE IMPACTED PRODUCT. THE PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY THE RIGHT HIP WAS CAPTURED UNDER (B)(4). DOI: (B)(6) 2014, DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 17939414 ↗
• InjurySep 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE RECEIVED: ON (B)(6) 2012, THE PATIENT HAD A LEFT HIP ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. NO MENTION OF MANUFACTURER OF CEMENT. ON (B)(6) 2021, THE PATIENT HAD A REVISION LEFT TOTAL HIP TO ADDRESS MECHANICAL COMPLICATION OF LEFT HIP PROSTHESIS. THE INDICATIONS FOR SURGERY INCLUDED, SYMPTOMS CONSISTENT WITH METALLOSIS AND EXCESSIVE WEAR. DURING THE PROCEDURE, THE SURGEON OBSERVED GROSS BLACK TISSUE STAINING AND A PSEUDOTUMOR. THE SURGEON NOTED THAT THE POLYETHYLENE SHELL COMPLETELY BROKEN FREE OF THE LINER AND THE HEAD WAS ARTICULATING WITH THE CUP. THERE WAS A LARGE AMOUNT OF TITANIUM WEAR DEBRIS IN THE SHELL. THE DEPUY ACETABULAR CUP WAS RETAINED AND THE SURGEON ELECTED TO USE A BUR TO ROUGHEN THE UNDERSURFACE OF THE CUP. THE SURGEON THEN ROUGHENED UP THE BACK OF THE NEW CUP AND CEMENTED THE COMPETITOR CUP INTO THE RETAINED DEPUY CUP. THE STEM, HEAD, AND ACETABULAR LINER WERE REMOVED. COMPETITOR COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. ON (B)(6) 2021 THE MEDICAL RECORDS NOTE THE PATIENT HAD MULTIPLE SURGERIES: 9 ON THE RIGHT HIP, 3 ON THE LEFT HIP (NO SPECIFIC INFO). PATIENT REPORTS HAVING CONST

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction

  MAUDE report 17798436 ↗
• InjurySep 22, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT STEM SUBSIDED AND BECAME LOOSE AT BONE TO IMPLANT INTERFACE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2013; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17797838 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO HIP PROTHESIS INFECTION. DOI:(B)(6) 2022 DOE: (B)(6) 2023 AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17489228 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND FRACTURED THE GREATER TROCHANTER. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Fall; Limb Fracture

  MAUDE report 17450662 ↗
• InjuryMay 3, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT HAD MULTIPLE SURGERIES. ON (B)(6) 2021 HEMI ARTHROPLASTY WAS DONE AND STEM REMAINS FROM THIS PROCEDURE. ON (B)(6) 2021 HIP DISLOCATED AND CONVERTED TO CONSTRAINED TOTAL HIP BY SURGEON. ON (B)(6) 2021 CUP WAS REVISED AND DUAL MOBILITY WAS PLACED BY SURGEON. DER WAS FILED, CUP AND SCREW THAT LISTED ON THE DER, PLACED AT THIS TIME. ON (B)(6) 2022 IT WAS CONVERTED TO DM TO CONSTRAINED DUE TO DISLOCATION. DER WAS SUBMITTED, HEAD AND LINER PLACED AT THIS TIME. PATIENT PRESENTS IN ER WITH A PERIPROSTHETIC FRACTURE OF RIGHT HIP WITH APPEARANCE OF POSSIBLE INFECTION SUPERIOR TO ACETABULAR COMPONENT. ALL COMPONENTS REMOVED AND PROSTALAC PLACED UNEVENTFULLY. THERE WAS LOOSENING OF FEMORAL COMPONENT POST FRACTURE AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Limb Fracture; Unspecified Infection

  MAUDE report 16859965 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WERE NO ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT.

  Patient problems: Limb Fracture

  MAUDE report 16833368 ↗
• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED OF HIP PAIN WITH A SQUEAKING NOISE DUE TO METALLOSIS OF LEFT HIP WITH A MOM BEARING. INCREASED BLOOD LEVELS OF COBALT AND CHROMIUM WAS ALSO NOTED PRIOR TO SURGERY THOUGH NORMAL WHITE BLOOD CELL COUNT. A STRAW COLORED FLUID WAS FOUND IN THE LEFT HIP, THERE WAS ALSO A GRAYISH DISCOLORATION OF THE SYNOVIUM ON THE LEFT HIP. DOI: (B)(6) 2009 DOR: (B)(6) 2020 AFFECTED SIDE: LEFT HIP.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Pain; Perforation of Vessels; Swelling/ Edema; Unspecified Infection

  MAUDE report 16572078 ↗
• InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISED A CORAIL/ PINNACLE CONSTRUCT WHICH WAS IMPLANTED OCT 2016. REVISION IS DUE TO SUSPECTED INFECTION PT REPORTS PAIN. DOI: OCT 2016, DOR: ON (B)(6) 2023, UNKNOWN SIDE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 16537323 ↗