CORAIL L20312Recalls & reported problems

Summary

The FDA's MAUDE database contains 113 adverse event reports that list this exact device (DI 10603295258032), received between Aug 9, 2017 and Apr 14, 2026 — classified as 107 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (21 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 113 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO A FRACTURED FEMUR. DOI: (B)(6)2015, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 24873461 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMES IN TODAY WITH CONSISTENT THIGH PAIN. THE DOCTOR FOUND IT BEST TO REMOVE THE STEM AND REPLACE IT WITH A RECLAIM MONO. THE DOCTOR ALSO DECIDED TO SWAP THE LINER WHILE REPLACING THE STEM. AFFECTED SIDE-RIGHT HIP.

  Patient problems: Pain

  MAUDE report 24603982 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR FRACTURE BELOW STEM. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 24268623 ↗
• MalfunctionOct 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY IN 2021 AND UNDERWENT REVISION SURGERY FOR A POLY INSERT IN 2023. TODAY HE BROKE THE NECK OF A CORAIL KHO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23404291 ↗
• InjuryOct 27, 2025Adverse 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 PERIPROSTHETIC FRACTURE. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 23389144 ↗
• InjuryJul 29, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO LOOSE CORAIL STEM 12 KHO. LOOSENING INTERFACE WAS NON-CEMENTED. CEMENT MANUFACTURER WAS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22647326 ↗
• InjuryApr 2, 2025Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: 1. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? - NO. 2. PLEASE CONFIRM THE LOOSENING INTERFACE. - BONE/IMPLANT. 3. PLEASE CONFIRM IF CEMENT WAS INVOLVED? IF YES, PLEASE CONFIRM THE MANUFACTURER OF THE CEMENT. - NO.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21753439 ↗
• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS BILATERAL ADVERSE REACTION TO METAL DEBRIS, ELEVATED METAL IONS, CYSTS IN TROCHANTERIC REGION, PSEUDOTUMOR. CLINICAL VISIT REPORTED MUSCLE FATIGUE, CYST AND SOME LUCENCY ON HIS FEMORAL COMPONENT. OPERATIVE NOTED REPORTED A LARGE FLUID COLLECTION IN THE HIPS AND NECROTIC TISSUES. THERE WAS A SYNOVIAL REACTION AND CYSTIC LESION ENCOUNTERED THESE WERE DEBRIDED AND FINAL REDUCTION WERE PERFORMED. DOI: ON (B)(6) 2007; DOR: ON (B)(6) 2012; LEFT HIP.

  Patient problems: Cyst(s); Foreign Body Reaction; Hypersensitivity/Allergic reaction; Necrosis; Swelling/ Edema

  MAUDE report 19688021 ↗
• InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED 18 JUN 2024. THIS PC WAS CREATED TO CAPTURE THE ALLEGATION OF ELEVATED COBALT LEVEL ON RIGHT HIP. DOI: (B)(6) 2008. DOR: UNKNOWN. LEFT HIP.

  Patient problems: Metal Related Pathology

  MAUDE report 19617728 ↗
• MalfunctionFeb 23, 2024Osseointegration Problem; Osseointegration Problem

  STUDY NO:(B)(6) CLINICAL ADVERSE EVENT RECEIVED FOR SIGNIFICANT HETEROTROPHIC OSSIFICATION AND POSSIBLE LOOSENING OF FEMORAL PROSTHESIS. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: ON (B)(6) 2022, DATE OF EVENT: 15 FEB 2024, (RIGHT HIP). TREATMENT: AWAITING FURTHER EVALUATION.

  Patient problems: Extraskeletal ossification; Inadequate Osseointegration

  MAUDE report 18766530 ↗
• 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 18603045 ↗
• InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Fall; Limb Fracture; Pain

  MAUDE report 18525272 ↗
• InjuryJan 5, 2024Osseointegration Problem; Osseointegration Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO ASEPTIC LOOSENING. DATE OF IMPLANT: (B)(6) 2017, DATE OF REVISION: (B)(6) 2023 (RIGHT HIP). TREATMENT: STEM, HEAD, AND LINER WERE REVISED. US-FDA MDR REPORTABILITY DETERMINATION: HIP WAS REVISED TO ADDRESS ASEPTIC IMPLANT LOOSENING OF THE FEMORAL STEM AT THE BONE TO IMPLANT INTERFACE. IT IS REASONABLE TO CONCLUDE THAT THE FEMORAL STEM ALONE CAUSED/CONTRIBUTED TO THE EVENT, SINCE THE INTEGRITY OF THE IMPLANT INTERFACE IS A DESIGN CHARACTERISTIC INHERENT TO THE MANUFACTURE OF THE STEM ALONE--NO OTHER IMPLANTS PLAY A ROLE IN MAINTAINING THAT INTERFACE INTEGRITY. HEAD AND LINER WERE CERTAINLY REVISED FOR WOUND EXPOSURE PURPOSES ONLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18452911 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION RECEIVED. FAILURE OF RECALLED HARDWARE OF LEFT TOTAL HIP ARTHROPLASTY. DOI: (B)(6) 2009. DOR: (B)(6) 2021. LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 18030404 ↗
• InjuryAug 25, 2023Osseointegration Problem; Osseointegration Problem

  PRIMARY HIP IMPLANTED DATE UNKNOWN. REVISION TOTAL HIP FOR PERIPROSTHETIC FRACTURE DUE TO A FALL. FEMORAL COMPONENTS REVISED DUE TO FRACTURE AND LOOSENING. THE ACETABULAR COMPONENTS UNAFFECTED AND REMAIN IMPLANTED. DOI: UNKNOWN. DOE: (B)(6) 2023. AFFECTED SIDE: LEFT.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 17623963 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR RESURFACING LITIGATION RECORDS RECEIVED. AFTER REVIEW OF RECORDS, THE PLAINTIFF ALLEGES PAIN, LOSS OF BALANCE, DIFFICULTY IN WALKING, UPSET STOMACH, METALLOSIS, TISSUE DEHISCENCE, TISSUE NECROSIS, BONE NECROSIS, HYPERTROPHIC SCARRING, ANTALGIA, LUMBAR STRAIN, DIZZINESS, CHRONIC FATIGUE, CHRONIC PAIN, SEVERE EMOTIONAL AND/OR PSYCHOLOGICAL DISTRESS RELATING TO THE PAIN AND SUFFERING AND ELEVATED METAL IONS. DOI: (B)(6) 2009. DOR: NONE REPORTED. UNKNOWN AFFECTED SIDE.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Distress; Dizziness; Foreign Body Reaction; Necrosis; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 17198489 ↗
• InjuryApr 27, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PROSTHESIS REVISED HERE IS A CORAIL AS INDICATED IN THE CST. THIS IS AN ALL-UNCEMENTED PROSTHESIS SO NO CEMENT IS USED.

  Patient problems: Pain

  MAUDE report 16822790 ↗
• InjuryMar 20, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT REQUEST: I AM LOOKING TO SPEAK TO SOMEONE ABOUT MY RECENT HIP REVISION SURGERY TO REMOVE THE DEPUY ASR ITEM. THE CONTACT INFORMATION FOR US ASR PATIENTS WHO HAVE HAD SURGERY TO REMOVE THEIR ASR HIP AFTER (B)(6) 2013, DOES NOT SEEM TO BE ACTIVE, THE PHONE NUMBER SAYS DISCONNECTED, AND THE WEBSITE (B)(6) CAN NOT BE REACHED. 2-MAR-2023: SPOKE WITH PATIENT VIA PHONE. HE INDICATED HIS RIGHT HIP WAS IMPLANT WITH ASR IN (B)(6) OF 2010 AND UNDERWENT A REVISION IN (B)(6) OF 2023 FOR PAIN, METALLOSIS, AND STEM LOOSENING. PATIENT IS SEEKING COMPENSATION FOR THE PAIN. PATIENT WILL BE EMAILED (WITHIN ECM) A CONTACT FOR COMPENSATION REQUEST. MEDICAL RECORDS. ON (B)(6) 2023 RIGHT METALLOSIS, FAILED ASR DEPUY SECONDARY TO METALLOSIS PATIENT WAS REVISED DUE TO INSULT WITH TRUNNIONOSIS WITH THE FAILED ASR. THE PATIENT HAD ELEVATED METAL LABS OF PSEUDOTUMOR. THE ACETABULAR COMPONENT WAS NEUTRAL INVERSION. THE FEMORAL STEM WAS COMPLETELY LOOSE AT LEAST EXPECTEDLY LOOSE PRIOR TO SURGERY. DOI: (B)(6) 2010; DOR: (B)(6) 2023; RIGHT HIP.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inadequate Osseointegration; Metal Related Pathology; Pain

  MAUDE report 16572253 ↗
• InjuryDec 27, 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: LEFT HIP.

  Patient problems: Pain

  MAUDE report 16051177 ↗
• InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTED HIP. SURGEON REMOVED ALL THE IMPLANTS, REAMED THE CANALS, IRRIGATED AND PLACED ANTIBIOTIC BEADS BEFORE RE-IMPLANTING. SURGEON USED A CORAIL REV STEM, CERAMIC HEAD AND ZIMMER CUP. NO FURTHER PATIENT INFORMATION WAS AVAILABLE AT THIS TIME. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15798894 ↗
• InjuryOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN TODAY WITH AN INFECTED RIGHT TOTAL HIP. THE SURGEON REMOVED ALL IMPLANTS TO PUT IN A PROSTALAC ANTIBIOTIC SPACER UNTIL THE INFECTION CLEARS. NO FURTHER PATIENT INFO IS AVAILABLE AT THIS TIME. DOI: (B)(6) 2018; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15594614 ↗
• InjurySep 15, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT FELL AND HAD A PERI PROSTHETIC FX. SURGEON REMOVED THE STEM AND REVISED TO A RECLAIM AND THERE WAS A LOOSENING OF FEMUR COMPONENT AT BONE TO IMPLANT INTERFACE. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI: (B)(6) 2020. DOR:(B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 15428512 ↗
• InjuryMay 25, 2022Use of Device Problem; Use of Device Problem

  MAL POSITION OF THE CORAIL PINNACLE NO ANTEVERSION ON THE CORAIL PINNACLE TO MUCH ANTEVERSION 50 DEGREES WITH IMPEACHMENT. DOE: MAY 10, 2022

  Patient problems: Insufficient Information

  MAUDE report 14495255 ↗
• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO FOR PERIPROSTHETIC FRACTURE. RECLAIM IMPLANTED. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.

  Patient problems: Limb Fracture

  MAUDE report 14107997 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROSTHESIS HAS BECOME PAINFUL FOLLOWING A FALL. DOI: UNK; DOR: UNK; UNKNOWN SIDE.

  Patient problems: Fall; Pain

  MAUDE report 13770592 ↗