CORAIL 3L93709Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10603295168867), received between Aug 8, 2017 and Sep 2, 2025 — classified as 1 death, 35 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 38 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN IN HIS LEG AND FELT THAT SOMETHING HAD CHANGED SINCE HIS SURGERY. X-RAYS REVEALED THAT THE DISTAL TIP OF THE STEM HAD FRACTURE OFF AND WAS LOSE INSIDE THE CANAL. SURGEON REMOVED CERAMIC HEAD, REMOVED THE OLD STEM WHICH CAME OUT EASY AND THE TREPHINEX DOWN TO REMOVE THE SMALL PIECE THAT WAS LODGED DISTAL. IN ADDITION, THE SURGEON SWAPPED OUT THE POLY LINER FOR A NEW ONE, CEMENTED IN A NEW STEM AND HEAD BEFORE REDUCING. NO FURTHER ISSUES WERE NOTED. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 22947779 ↗
• InjuryJan 7, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S STEM WAS REVISED FOR PAIN. IT IS UNKNOWN IF THERE WAS A LOOSENING. DOI: (B)(6) 2019. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21091724 ↗
• MalfunctionJul 16, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE CUSTOMER RECEIVED WET IMPLANTS. MULTIPLE PRODUCTS ARE DAMAGED. THE CASE WAS PUSHED TO TODAY FROM LAST THURSDAY.

  Patient problems: Insufficient Information

  MAUDE report 19750145 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: WAS THERE ANY PATIENT HARM/CONSEQUENCE RELATED TO THE EVENT? THE PATIENT BROKE THEIR FEMUR WHEN THEY FELL AS STATED IN REPORT. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO.

  Patient problems: Fall; Limb Fracture

  MAUDE report 19449184 ↗
• MalfunctionMay 5, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED BEFORE THE SURGERY THAT THE PACKAGING OF THE PRODUCT WAS FOUND TO BE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16876338 ↗
• InjuryFeb 1, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration

  CLINICAL ADVERSE EVENT RECEIVED FOR REVISION DUE TO ASEPTIC LOOSENING; LOOSENING OF THE STEM. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2012. DATE OF EVENT: (B)(6) 2020. (RIGHT HIP). TREATMENT: REVISION; LINER, HEAD, AND STEM WERE REVISED.

  Patient problems: Inadequate Osseointegration; Pain; Unspecified Tissue Injury

  MAUDE report 16276921 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THE SURGERY WITH THE STEM IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT HAD A PERI-STEM BONE FRACTURE. THE STEM WAS REMOVED ON UNKNOWN DATE. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Limb Fracture

  MAUDE report 15923939 ↗
• InjurySep 23, 2022Osseointegration Problem; Osseointegration Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ASEPTIC LOOSENING. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2013, DATE OF REVISION: (B)(6) 2022, DATE OF EVENT: (B)(6) 2022, (RIGHT HIP). TREATMENT: REVISION; LINER, STEM, AND HEAD WERE REMOVED. ADDITIONAL INFORMATION: REVISION WAS COMPLETED DUE TO PAIN AND FEMORAL STEM LOOSENING UPON ENTERING THE JOINT, SCAR TISSUE WAS ENCOUNTERED AND REMOVED. THE FEMORAL STEM WAS NOTED TO BE GROSSLY LOOSE AT THE BONE TO IMPLANT INTERFACE. THE POLY LINER WAS NOTED TO HAVE SOME WEAR. THE HEAD AND STEM WERE REVISED TO COMPETITOR PRODUCT, LINER WAS REVISED WITH DEPUY, CUP LEFT IN PLACE. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON.

  Patient problems: Adhesion(s); Inadequate Osseointegration; Pain; Scar Tissue

  MAUDE report 15470383 ↗
• InjuryMay 13, 2022Use of Device Problem; Use of Device Problem

  THE PATIENT HAD PAIN IN HIS LEFT THP BECAUSE THE STEM WAS IMPLANTED IN VARUS. DOI: UNKNOWN. DOR: UNKNOWN. LEFT HIP.

  Patient problems: Pain

  MAUDE report 14396210 ↗
• InjuryFeb 28, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE SURGEON INDICATED FOR A LOOSE FEMORAL STEM. NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022; AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13618676 ↗
• InjuryJan 14, 2022Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO THE PATIENT'S FALLING DURING REHAB AND LOOSENING AT AN UNCEMENTED INTERFACE AT THE STEM AND CUP COMPONENTS. SURGERY WAS JUST DONE ON (B)(6)2021. IMPLANTS DISLODGED AFTER FALL. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Inadequate Osseointegration

  MAUDE report 13257604 ↗
• InjuryDec 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION UPDATE WAS REVIEWED AND THE DIAGNOSIS HAS BEEN UPDATED FROM SURGICAL SITE INFECTION TO STITCH ABSCESS.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 13102233 ↗
• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2021, LEFT HIP.

  Patient problems: Pain

  MAUDE report 12583705 ↗
• InjuryMay 14, 2021Migration; Migration

  QUESTIONS: A. WAS THERE A SURGICAL DELAY DURING THE REVISION SURGERY? IF YES, WHAT WAS THE DURATION OF THE DELAY? B. WAS THE PATIENT EXPERIENCING ANY ADVERSE SYMPTOMS THAT LED TO THE REVISION SURGERY? ANSWERS FOR YOUR QUESTIONS: PATIENT WAS REVISED DUE TO PAINFUL TOTAL HIP. THERE WAS NO SURGICAL DELAY.

  Patient problems: Insufficient Information; Pain

  MAUDE report 11825553 ↗
• InjuryNov 12, 2020Loss of Osseointegration; Loss of Osseointegration

  REVISION OF THE CORAIL PINNACLE. THE PROXIMAL FEMORAL COMPONENT SHOWED SIGNS OF LOOSENING. PATIENT HAD THIGH PAIN.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 10829261 ↗
• InjuryJul 22, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT FEMORAL STEM WAS LOOSE AT BONE TO IMPLANT INTERFACE. DOI: UNKNOWN, DOR: (B)(6) 2020, AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10308587 ↗
• InjuryJul 14, 2020Loss of Osseointegration; Unintended Movement; Migration; Loss of Osseointegration; Unintended Movement; Migration

  REVISION OPERATIVE NOTES 06/10/2020 INDICATE THE PATIENT RECEIVED A LEFT TOTAL HIP REVISION DUE TO PAIN, WITH LOOSENING, SUBSIDENCE AND VARUS ANGULATION OF THE FEMORAL STEM. UPON ENTERING THE JOINT, THE FEMORAL STEM WAS NOTED TO BE GROSSLY LOOSE. SIGNIFICANT SCAR TISSUE AND BONE WAS REMOVED FROM THE MEDIAL GREATER TROCHANTER FOR ACCESS. SCAR TISSUE WAS ALSO NOTED TO BE REMOVED FROM THE ACETABULAR SIDE. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON.

  Patient problems: Adhesion(s); Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 10271730 ↗
• InjuryJul 1, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT STEM BECAME LOOSE, REMOVED THE STEM AND PUT A SUMMIT CEMENTED AND READJUSTED CUP VERSION WITH A NEW CUP. DOI: (B)(6) 2019, DOR: (B)(6) 2020, LEFT SIDE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10219240 ↗
• InjuryMay 29, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A CORAIL STEM AND PINNACLE CUP THAT THE LINER HAD DISASSOCIATED FROM THE CUP. UPON SURGERY IT WAS DISCOVERED THAT THE STEM WAS LOOSE AND PULLED OUT BY HAND. SURGEON REPLACED LINER AND CONVERTED TO AN ACTIS STEM. ALL PARTS WERE SOLID AFTER REPLACING. DOI: (B)(6) 2015; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10102827 ↗
• InjuryMay 19, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT HAD A LOOSE FEMORAL STEM. SURGEON REVISED THE STEM AND REPLACED THE LINER AND HEAD DOI: (B)(6) 2018. DOR: (B)(6) 2020; AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10070711 ↗
• InjuryJan 7, 2020Loss of Osseointegration; Biocompatibility; Loss of Osseointegration; Biocompatibility

  SCF AND MEDICAL RECORD RECEIVED. SCF ALLEGES PAIN AND ALVAL/SOFT TISSUE. AFTER REVIEW OF MEDICAL RECORD, OPERATIVE NOTE REPORTED LOOSENING OF THE ACETABULAR AND FEMORAL COMPONENT.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Pain; Test Result

  MAUDE report 9559016 ↗
• InjuryAug 7, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF AND STICKER SHEETS RECORD RECEIVED. PPF ALLEGES LOOSENING OF THE STEM, METAL WEAR AND METALLOSIS. DOI: (B)(6) 2010, DOR: (B)(6) 2018, (RIGHT HIP).

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; No Code Available

  MAUDE report 8871194 ↗
• InjuryJul 23, 2019Loss of Osseointegration; Loss of Osseointegration

  REVISION OF FEMORAL COMPONENT CORAIL FEMORAL COMPONENT FOR WHAT IS BELIEVED TO BE ASEPTIC LOOSENING. FEMORAL COMPONENT, FEMORAL HEAD AND ACETABULAR LINER REVISED. IMPACTED PRODUCTS: 1 X 3L93709; CORAIL2 LAT COXA VARA SIZE 9; LOT NO: 5271037- DISCARDED; 1 X 122136052; ALTRX NEUT 36IDX52OD; LOT NO: C82285 - DISCARDED; 1 X 136536310; DELTA CER HEAD 12/14 36MM +1.5; LOT NO: 8198858 - DISCARDED; 1 X 121732052; PINN SECTOR W/GRIPTION 52MM; LOT NO: 753770- STILL IMPLANTED.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8818171 ↗
• InjuryMay 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RECENTLY STARTED COMPLAINING OF THIGH PAIN IN THE RIGHT HIP. A BRIDGING PEDISTLE HAD DEVELOPED AT THE DISTAL TIP OF THE CORAIL STEM. THE SURGEON REMOVED THE CORAIL STEM, HEAD AND PINNACLE LINER. THE PINNACLE CUP REMAINED IMPLANTED. DOI: (B)(6) 2016; DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 8624588 ↗
• InjuryMay 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC FRACTURE. LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 8570298 ↗