CORAIL 3L92499Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 10603295168652), received between May 25, 2017 and Jun 26, 2026 — classified as 66 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (14 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 69 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2026Osseointegration Problem

  IT WAS REPORTED THAT PATIENT HAD PRIOR TOTAL HIP SURGERY. PATIENT PRESENTED WITH A LOOSE CORAIL STEM WHICH WAS REMOVED AND REPLACED WITH A COMPETITIVE STEM. THE PINNACLE LINER WAS REMOVED AND REPLACED WITH A DUAL MOBILITY CONSTRUCT. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 25635095 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS NOT STABLE-HIP. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 24581384 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: 1. CAN YOU PLEASE PROVIDE THE LOT NUMBER OF THE "PINN MULTIHOLE W/GRIPTION 48MM"? - UNFORTUNATELY THE LOT NUMBER WASN'T LEGIBLE. 2.VWHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? LEFT OR RIGHT? -LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 24144671 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. EVERYTHING CAME OUT. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22828516 ↗
• MalfunctionJan 2, 2025No Apparent Adverse Event; Missing Information; No Apparent Adverse Event; Missing Information

  IT WAS REPORTED THE PRODUCT DID NOT HAVE THE TRACEABILITY LABEL.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21058678 ↗
• InjuryDec 4, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT STEM WAS LOOSE. STEM DIDN'T GROW IN PROXIMAL. THERE WAS NO DELAY IN SURGERY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20846058 ↗
• InjuryNov 7, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. THE KA STEM WAS GROSSLY LOOSE AND CAME RIGHT OUT. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 20629082 ↗
• InjurySep 20, 2024Adverse 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) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20267484 ↗
• InjuryJun 3, 2024Adverse 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- UNKNOWN DOR- (B)(6) 2024 AFFECTED SIDE- LEFT HIP.

  Patient problems: Pain

  MAUDE report 19446929 ↗
• InjuryFeb 28, 2024Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL STEM AT NON CEMENTED INTERFACE. THE HEAD AND POLY WERE CHANGED. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE : RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18799182 ↗
• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2014. DATE OF REVISION: (B)(6) 2023. (RIGHT HIP). TREATMENT: STEM, HEAD, LINER, AND SHELL REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 18740045 ↗
• InjuryJun 1, 2023Osseointegration Problem; Osseointegration Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ASEPTIC LOOSENING OF STEM. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DOI: (B)(6) 2008. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP. TREATMENT: REVISION; LINER, STEM, AND HEAD WERE REVISED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17040457 ↗
• InjuryFeb 16, 2023Osseointegration Problem; Osseointegration Problem

  REVISION COMPLETED DUE TO STEM LOOSENING. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16386244 ↗
• InjuryNov 30, 2022Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  PINNACLE LITIGATION RECORDS RECEIVED. PATIENT IS SCHEDULED TO UNDERGO A REVISION SURGERY ON (B)(6) 2022 DUE TO HEAVY METAL POISONING. RECORDS ALSO ALLEGES PAIN, INJURY, SCAR TISSUE FORMATION, METALLOSIS, METAL WEAR AND LIMITATION OF DAILY ACTIVITIES. DOI: (B)(6) 2011. DOR: (B)(6) 2022. RIGHT HIP. PLEASE SEE (B)(4) FOR LEFT HIP.

  Patient problems: Foreign Body Reaction; Loss of Range of Motion; Metal Related Pathology; Osteolysis; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 15890991 ↗
• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TOTAL EXPLANT WITH ANTIBIOTIC SPACER INSERTION DUE TO INFECTED LEFT HIP. NO ADDITIONAL INFORMATION. THERE IS NO SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15788048 ↗
• InjuryNov 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. NO ADDITIONAL INFORMATION. DOI- UNKNOWN. DOR- (B)(6) 2022. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15715404 ↗
• InjuryAug 30, 2022Degraded; Osseointegration Problem; Degraded; Osseointegration Problem

  PATIENT UNDERWENT REVISION OF THE STEM AND LINER OF THE LEFT HIP. PATIENT HAD PINNACLE MOM LINER AND A CORAIL HIP STEM. PATIENT WAS EXPERIENCING PAIN AND ON X-RAY SHOWED METALLOSIS AROUND THE STEM. SURGEON SAID THAT HE DID NOT SEE ANY DAMAGE TO THE SOFT TISSUES BUT THERE WAS A LOT OF BONE LOSS AROUND THE STEM AND IT WAS GROSSLY LOOSE. FEMORAL STEM WAS LOOSE AT A NON-CEMENTED INTERFACE. THE CORAIL STEM CAME OUT WITH THE SURGEON'S FINGERS. THERE WERE NOTICEABLE MARKINGS ON BOTH THE METAL LINER AND TRUNNION. SURGEON THOUGHT THE CUP WAS IN GOOD POSITION AND WELL FIXED SO HE DECIDED TO LEAVE IN PLACE. REMOVED BOTH THE METAL LINER, STEM AND HEAD AND REPLACED THEM WITH A POLY LINER, RECLAIM STEM AND CERAMIC HEAD. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Adhesion(s); Foreign Body Reaction; Inadequate Osseointegration; Loss of Range of Motion; Metal Related Pathology; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 15321509 ↗
• InjuryAug 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 15193926 ↗
• InjuryJul 19, 2022Osseointegration Problem; Osseointegration Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO ASEPTIC LOOSENING. DATE OF IMPLANT: (B)(6) 2012. DATE OF REVISION: (B)(6) 2022. LEFT HIP. TREATMENT: REMOVAL OF STEM, HEAD, AND LINER. WERE DEPUY COMPONENTS REMOVED: YES.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15051339 ↗
• InjuryJun 27, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT DISLOCATED HIP AND DR. WAS UNABLE TO PERFORM CLOSED REDUCTION. LOOSENING OF THE STEM AT BONE TO IMPLANT INTERFACE WAS ALSO REPORTED. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14830514 ↗
• InjuryApr 21, 2022Degraded; Degraded

  ASR CLAIM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS FAILED LEFT THR WITH PLACEMENT OF DUAL MOBILITY COMPONENT. OPERATIVE NOTE REPORTED A LARGE AMOUNT OF CLEAR TO SLIGHTLY YELLOW TINTED FLUID WITHIN THE JOINT. THERE WAS CORROSION OF MILD DEGREE AT THE TRUNNION OF THE FEMORAL COMPONENT AND FEMORAL PROSTHETIC HEAD. DOI: (B)(6) 2009; DOR: (B)(6) 2021 ; LEFT HIP.

  Patient problems: Foreign Body Reaction; Swelling/ Edema

  MAUDE report 14166524 ↗
• InjuryMar 3, 2022Adverse 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) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 13658803 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PERIPROSTHETIC FEMORAL FRACTURE WAS DISCOVERED. CAUSE IS UNKNOWN. DOI: (B)(6) 2022. DOR: (B)(6) 2022.

  Patient problems: Limb Fracture

  MAUDE report 13601397 ↗
• InjuryNov 16, 2021Osseointegration Problem; Osseointegration Problem

  A. WAS THERE A SURGICAL DELAY BECAUSE OF THIS EVENT? IF YES, WHAT WAS THE DURATION OF THE DELAY? NO. B. WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? RIGHT SIDE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12819880 ↗
• InjuryOct 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Limb Fracture

  MAUDE report 12668779 ↗