CORAIL 3L92504Recalls & reported problems
Depuy (Ireland) · CORAIL HIP SYSTEM CEMENTLESS FEMORAL STEM 12/14 AMT 135 DEGREES KA SIZE 14 HA COATED STANDARD COLLAR · Class 2 · Implant
Quick summary
This DePuy Corail cementless femoral stem is used in hip replacement surgery. The 34 reports mostly describe the stem loosening or sinking in the bone instead of growing into it, along with hip pain and infection that led patients to have revision surgery; 32 reports involve injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10603295168706), received between Mar 18, 2014 and Dec 8, 2025 — classified as 32 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem13
- Insufficient Device Problem Information7
- Osseointegration Problem5
- Fracture2
- Loss of Osseointegration2
- Migration2
- Appropriate Device Problem Term/Code Not Available1
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Code Available10
- Inadequate Osseointegration8
- Pain8
- Unspecified Infection6
- Not Applicable5
- Foreign Body Reaction4
- Test Result4
- Fall3
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE IMPLANT DOESN'T SEEM TO BE STERILE. BAG IS NOT VACUUM SEALED LIKE OTHER IMPLANTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23747478 ↗InjuryAug 27, 2025Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THERE WAS A LOOSE CORAIL STEM. NO BONY ON GROWTH. REVISION OCCURRED (B)(6) 2025
Patient problems: Inadequate Osseointegration
MAUDE report 22904785 ↗InjuryJun 23, 2025Migration; Migration
IT WAS REPORTED THAT PATIENT UNDERWENT REVISION HIP SURGERY. THE STEM WAS SUBSIDED. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Insufficient Information
MAUDE report 22310027 ↗InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION DUE TO INFECTION. PSEUDOMONAS INFECTION, LIKELY AS A RESULT OF THE CANNULA DONE BY NURSING STAFF IN ICU. ALL IMPLANTS WERE REMOVED.
Patient problems: Unspecified Infection
MAUDE report 21943801 ↗InjuryApr 17, 2025Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT FEMORAL COMPONENT WAS LOOSE AT NON-CEMENTED INTERFACE. NON CEMENTED CORAIL STEM WAS USED. FEMORAL REVISION, HEAD REVISION , LINER REVISION WAS DONE. REASON FOR LINER EXCHANGE WAS TO REPLACE THE OLD LINER WITH A NEW LINER. THERE WAS NO ALLEGATIONS FOR LINER OR APEX HOLE ELIMINATOR. THERE WAS NO DELAYS IN SURGERY. AFFECTED SIDE: LEFT HIP.
Patient problems: Inadequate Osseointegration
MAUDE report 21853663 ↗InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. REMOVAL OF PROSTHETHESIS INSERTION OF ANTIBIOTIC SPACER. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 21577332 ↗InjuryDec 2, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO A DISLOCATION ISSUE. THERE WAS A STEM LOOSENING. CEMENT MANUFACTURER WAS UNKNOWN. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT HIP.
Patient problems: Inadequate Osseointegration
MAUDE report 20820888 ↗InjuryJun 6, 2023Osseointegration Problem; Osseointegration Problem
PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL STEM AT BONE TO IMPLANT INTERFACE. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.
Patient problems: Inadequate Osseointegration
MAUDE report 17073656 ↗InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION THR - PERIPROSTHETIC FRACTURE PATIENT STATUS/ OUTCOME / CONSEQUENCES , WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY : UNKNOWN, (B)(4) DEVICE PROPERTY OF : NONE, DEVICE IN POSSESSION OF : NONE, (B)(4) DEVICE PROPERTY OF : NONE, DEVICE IN POSSESSION OF : NONE, (B)(4) DEVICE PROPERTY OF : NONE, DEVICE IN POSSESSION OF : NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST .TRUE.
Patient problems: Fall; Limb Fracture
MAUDE report 17049263 ↗InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 16940837 ↗InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CLINICAL ADVERSE EVENT RECEIVED FOR ADVERSE TISSUE REACTION AND HIGH COBALT BLOOD LEVELS. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF REVISION: (B)(6) 2023 DATE OF IMPLANT: (B)(6) 2008 DATE OF EVENT: (B)(6) 2022 (RIGHT HIP) TREATMENT: REVISION; HEAD AND LINER WERE REVISED.
Patient problems: Foreign Body Reaction; Metal Related Pathology
MAUDE report 16713017 ↗InjuryApr 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON JANUARY 29, 2023, THE PRIMARY SURGERY WAS PERFORMED VIA BHA WITH THE IMPLANT IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. POSTOPERATIVELY, THE PATIENT FELL AND DISLOCATED. THE REVISION SURGERY IS SCHEDULED ON (B)(6) 2023, AS GIRDLESTONE SURGERY. BECAUSE THE POSTERIOR WALL OF THE ACETABULUM IS BROKEN, ONLY EXTRACTION WILL BE PERFORMED AND NO REPLACEMENT WILL BE INSERTED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Fall
MAUDE report 16688916 ↗MalfunctionDec 20, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE STEM EXTRACTOR BROKE RESULTING IN THE THREADED TIP BREAKING OFF INTO THE CORAIL IMPLANT ITSELF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16017038 ↗InjuryAug 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO PAINFUL HIP. NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT HIP.
Patient problems: No Code Available; Pain
MAUDE report 10409637 ↗InjuryJul 24, 2020Loss of Osseointegration; Unintended Movement; Migration; Loss of Osseointegration; Unintended Movement; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR TOTAL HIP REPLACEMENT 2 WEEKS AGO. THE PATIENT FELL SHORTLY AFTER INITIAL SURGERY AND FRACTURED AROUND THE DISTAL END OF THE STEM. PATIENT STEM THE SUBSIDED AND CREATED A FULL PERI-PROSTHETIC FRACTURE. THE PATIENT WAS REVISED TO A REVISION STEM. DOI: (B)(6) 2020, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.
Patient problems: Bone Fracture(s); Fall; Inadequate Osseointegration; No Code Available
MAUDE report 10322106 ↗InjuryJun 29, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT POSTOPERATIVE, THE DOCTOR NOTICED WRONG HIP STEM WAS IMPLANTED (KA / KLA) REQUIRING A TAKE OUT AND REIMPLANTATION THAT AFTERNOON. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT SIDE.
Patient problems: No Code Available
MAUDE report 10206176 ↗InjuryMay 20, 2020Fracture; Fracture
FRACTURE OF THE BASE OF THE PROSTHETIC NECK OF A FEMORAL STEM: RIGHT HIP PROSTHESIS IMPLANTED IN 2003.
Patient problems: No Code Available
MAUDE report 10075469 ↗InjuryFeb 5, 2020Fracture; Fracture
THE PATIENT WAS REVISED TO ADDRESS BROKEN STEM BOUT 20 MM BELOW THE HEAD AND NECK JUNCTION. PATIENT UNDER WENT TOTAL HIP ARTHROPLASTY IN 2012. SURGEON REMOVED STEM AND HEAD/NECK SEGMENT AND REPLACED WITH A CONSTRAINED LINER AND A SIMMER STEM. DOI: 2012; DOR: (B)(6) 2020; LEFT HIP.
Patient problems: No Code Available
MAUDE report 9673056 ↗InjuryAug 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED TO ADDRESS HIP PAIN AND METALOSIS. PPF ALLEGES ELEVATED METAL IONS. THERE IS NO LAB RESULTS FOR THE ALLEGED ELEVATED METAL IONS IN THE PREVIOUS MEDICAL RECORD. DOI: (B)(6) 2010, DOR (B)(6) 2013, (LEFT HIP).
Patient problems: Foreign Body Reaction; No Code Available; Pain; Test Result
MAUDE report 8864230 ↗InjuryFeb 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED TO ADDRESS INFECTION. COMPONENTS REMOVED. DOI: (B)(6) 2018; DOR: (B)(6) 2019; LEFT HIP.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 8343084 ↗InjuryJan 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LITIGATION ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2008; DOR: (B)(6) 2014; (RIGHT HIP).
Patient problems: No Code Available; Pain; Test Result; Tissue Damage
MAUDE report 8253405 ↗InjuryOct 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PPF ALLEGES METAL WEAR AND ELEVATED METAL IONS. DOI: (B)(6) 2008; DOR: (B)(6), 2010; (LEFT HIP).
Patient problems: Not Applicable; Pain; Swelling; Test Result
MAUDE report 7942294 ↗InjurySep 26, 2018Osseointegration Problem; Osseointegration Problem
PATIENT WAS REVISED TO ADDRESS LOOSENING OF STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2018. DOR: (B)(6) 2018; RIGHT HIP.
Patient problems: Inadequate Osseointegration
MAUDE report 7909520 ↗InjuryAug 22, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, PSEUDOTUMOR, METAL WEAR AND METALLOSIS, AND ELEVATED METAL IONS. DOI: (B)(6) 2010; DOR: NOT REPORTED; (RIGHT HIP).
Patient problems: Ambulation or Postural Difficulties; Discomfort; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Pain; Test Result; Tissue Damage
MAUDE report 7804704 ↗InjuryJun 4, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
DER STATES ELEVATED COBALT ION LEVELS, PAIN, RADIOLOGICAL CHANGES, MRI- PSEUDOTUMOR. DOI: (B)(6) 2009; DOR: (B)(6) 2018; LEFT HIP.
Patient problems: No Code Available; Not Applicable; Pain; Tissue Damage
MAUDE report 7565834 ↗
Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate devices
- Novation 130-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls156 reports
- Novation 130-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls79 reports
- CORAIL 3L92511Depuy (Ireland) · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate158 reports
- Acumatch A Series 138-36-29Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 recalls1 report
- Novation 136-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls43 reports
- Novation 130-32-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls33 reports
- Novation 132-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls26 reports
- Novation 136-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls22 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.