CORAIL L94004Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295325154), received between May 4, 2018 and Feb 13, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Material Deformation

  STERILISING DEPARTMENT ADVISED THE INSTRUMENT HAD A DAMAGED CLIP/RING AND SAID IT WAS NOT ABLE TO BE RE-STERILISED AND PUT BACK INTO CIRCULATION. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO PATIENT INVOLVEMENT, 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 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332418 ↗
• MalfunctionDec 17, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ARTIFICIAL FEMORAL HEAD REPLACEMENT USING CORAIL FEMORAL TRIALS. DURING TEMPORARY REDUCTION, THE SURGEON TRIED TO ATTACH A HEAD TRIAL TO FEMORAL TRIAL, BUT THEY COULD NOT BE ATTACHED UNTIL THE CLICK SOUND WAS HEARD. AFTER THAT CLICK, THE SURGEON WAS ABLE TO FIT THE HEAD TRIAL ONTO THE FEMORAL TRIAL OUTSIDE THE SURGICAL FIELD BY APPLYING FORCE WITH BOTH HANDS. THE SURGEON COMMENTED THAT THE PRODUCT WAS DEFECTIVE. THE HOSPITAL COMMENTED THAT IT WAS POSSIBLE THAT THE STOPPER PART (RING PART) OF THE FEMORAL TRIAL WAS DEFORMED (OR LOOSENED). THE SURGERY WAS COMPLETED SUCCESSFULLY, WITH A THIRTY-MINUTE DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23826700 ↗
• MalfunctionJul 3, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A THA SURGERY WITH CORAIL PERFORMED WITH THE PRODUCT IN QUESTION. IN THE SURGERY DURING THE TRIAL, THE CORAIL AMT BROACH SIZE 15 AND THE CORAIL AMT NECK SEGMENT KLA 125 DEGREES DID NOT FIT TOGETHER PROPERLY, WHICH EXTENDED THE PROCEDURE TIME BY ABOUT 15 MINUTES. AFTER SEVERAL TRIALS, IT WAS CONFIRMED THAT THE PRODUCTS FIT TOGETHER, BUT THEY COULD NOT BE ATTACHED OR DETACHED SMOOTHLY. THE SURGEON CHECKED FIVE NECKS OF THE PRODUCTS IN QUESTION, AND FOUND THAT, LIKE THE ISSUE IN QUESTION, THEY COULD BE FITTED TOGETHER BUT COULD NOT BE REMOVED SMOOTHLY. IN ADDITION, SINCE THE ISSUE WAS NOT CONFIRMED WITH OTHER SIZE BROACHES AND NECK SEGMENTS, THERE MAY BE A PROBLEM WITH THE CORAIL AMT BROACH SIZE 15. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 15 MINUTES OF SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396490 ↗
• MalfunctionSep 16, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT FAILURE TO ENGAGE THE TEST HEAD WITH A RISK OF DISENGAGEMENT.

  Patient problems: Insufficient Information

  MAUDE report 20223415 ↗
• MalfunctionJun 5, 2024Break; Break

  IT WAS REPORTED THAT NECK AND TIP OF BROACH BROKE OFF. NO PIECES WERE LEFT INSIDE THE PATIENT. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 19468121 ↗
• MalfunctionMay 7, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE NECK SEGMENT IS DIFFICULT TO SECURE ON MOST BROACHES, BUT PARTICULARLY THE BROACH SIZE 13.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14321704 ↗
• MalfunctionMar 1, 2022Device-Device Incompatibility; Device-Device Incompatibility

  THE NECK SEGMENT IS DIFFICULT TO SECURE ON MOST BROACHES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13635565 ↗
• MalfunctionNov 12, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT 2 CORAIL BROACHES AND 1 NECK SEGMENT DO NOT CONNECT TOGETHER TO FORM A TRAIL FOR A UNCEMENTED HIP REPLACEMENT. THIS WAS FOUND DURING SURGERY, THERE WAS NO DELAY IN SURGERY AS THEY HAD A SPARE SET TO HAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12802916 ↗
• MalfunctionFeb 21, 2020Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  TRIAL HEAD DID NOT FIT ONTO TRIAL NECK DUE TO DAMAGE OF THE METAL O RING, TRIALS ALL NEED REPLACING OFF CONSIGNED KIT, HANA TABLE FEMORAL BOLSTER AND PERINEAL POST PADDING NEEDS REPLACING DUE TO RIPPING OF RUBBER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9741119 ↗
• MalfunctionDec 21, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  BLOOD AND DEBRI GETS CAUGHT BEHIND NECK TRIAL O RINGS. NO DELAY TO PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8190106 ↗
• MalfunctionNov 9, 2018Component Missing; Component Missing

  SHORT NECK TRIAL OPTION IS MISSING THE METAL RING AT THE BASE OF THE TRUNNION WHICH SECURES THE HEAD TRIAL IN PLACE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8054683 ↗
• MalfunctionOct 11, 2018Problem with Sterilization; Problem with Sterilization

  IT WAS REPORTED THAT THE RUBBER RING AND AREA BEHIND THE RUBBER RING IN EACH TRIAL NECK CONTAINS DRIED BLOOD WHEN REMOVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7955671 ↗
• MalfunctionOct 11, 2018Problem with Sterilization; Problem with Sterilization

  IT WAS REPORTED THAT THE RUBBER RING AND AREA BEHIND THE RUBBER RING IN EACH TRIAL NECK CONTAINS DRIED BLOOD WHEN REMOVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7955670 ↗
• MalfunctionOct 8, 2018Device-Device Incompatibility; Device-Device Incompatibility

  CORAIL NECK SEGMENTS NOT SITTING ON BRANCHES PROPERLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7944632 ↗
• MalfunctionSep 24, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  COMPLAINT DESCRIPTION: IT WAS REPORTED THAT THE O-RINGS ON THE CORAIL FEMORAL NECK TRIAL INSERTS HAS NOT BEEN CLEANED PROPERLY AND HAVING SMALL AMOUNT OF DIRT UNDERNEATH THEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7901813 ↗
• MalfunctionSep 13, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE RUBBER RING AND AREA BEHIND THE RUBBER RING IN EACH TRIAL NECK CONTAINS DRIED BLOOD WHEN REMOVED. THIS IS UNSTERILE AND PRESENTS A STERILITY RISK. THE CSSD DEPARTMENT WILL NOT RE-STERILISE THE TRIAL NECKS WITHOUT THE RUBBER RING UNLESS PROVIDED WRITTEN APPROVAL FROM J&J TO DO THIS. ALL CORAIL TRIAL NECKS WERE EXAMINED AT THE HOSPITAL AND ALL WERE FOUND TO HAVE DRIED BLOOD IN THE AREA BEHIND THE RUBBER RING, WHICH HOLDS THE TRIAL NECK TO THE FEMORAL BROACH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7872689 ↗
• MalfunctionSep 13, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE RUBBER RING AND AREA BEHIND THE RUBBER RING IN EACH TRIAL NECK CONTAINS DRIED BLOOD WHEN REMOVED. THIS IS UNSTERILE AND PRESENTS A STERILITY RISK. THE CSSD DEPARTMENT WILL NOT RE-STERILISE THE TRIAL NECKS WITHOUT THE RUBBER RING UNLESS PROVIDED WRITTEN APPROVAL FROM J&J TO DO THIS. ALL CORAIL TRIAL NECKS WERE EXAMINED AT THE HOSPITAL AND ALL WERE FOUND TO HAVE DRIED BLOOD IN THE AREA BEHIND THE RUBBER RING, WHICH HOLDS THE TRIAL NECK TO THE FEMORAL BROACH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7872618 ↗
• MalfunctionAug 24, 2018Naturally Worn; Naturally Worn

  SURGEON: DR (B)(6). PROCEDURE: TOTAL HIP REPLACEMENT. THE "O" RINGS INSIDE THE NECK SEGMENT TRIALS COLLECT DEBRIS THEREFORE THIS HOSPITAL REMOVES THE "O" RINGS AFTER EVERY CASE FOR CLEANING. THEY THEN BECOME WORN AND NEED REPLACEMENT. NO AE TO PATIENT. WHEN DID THE DEVICE ISSUE HAPPEN: AFTER USE ON PATIENT. ACTION TAKEN TO MANAGE THE PROBLEM: REPLACE THE "O" ROUTINELY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7813878 ↗
• MalfunctionMay 8, 2018Device Reprocessing Problem; Device Reprocessing Problem

  WE EXAMINED OUR LOAN SETS (6) AND FOUND MANY HAD THIS DEBRIS. PRODUCT CODES L94003, L94004, L94005, L94006, L94007 (1 SET). SIX SETS. WE EXAMINED OUR LOAN SETS (6) AND FOUND MANY HAD THIS DEBRIS, THESE HAVE ALL BEEN CLEANED AND REMAIN IN CIRCULATION. THEY ARE NOW INSPECTED WHEN THEY RETURN TO OUR FACILITY, AND NONE HAVE BEEN FOUND TO HAVE FURTHER DEBRIS BUILD UP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7494033 ↗
• MalfunctionMay 8, 2018Device Reprocessing Problem; Device Reprocessing Problem

  WE EXAMINED OUR LOAN SETS (6) AND FOUND MANY HAD THIS DEBRIS. PRODUCT CODES L94003, L94004, L94005, L94006, L94007 (1 SET). SIX SETS. WE EXAMINED OUR LOAN SETS (6) AND FOUND MANY HAD THIS DEBRIS, THESE HAVE ALL BEEN CLEANED AND REMAIN IN CIRCULATION. THEY ARE NOW INSPECTED WHEN THEY RETURN TO OUR FACILITY, AND NONE HAVE BEEN FOUND TO HAVE FURTHER DEBRIS BUILD UP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7493975 ↗
• MalfunctionMay 8, 2018Metal Shedding Debris; Metal Shedding Debris

  WE EXAMINED OUR LOAN SETS (6) AND FOUND MANY HAD THIS DEBRIS. PRODUCT CODES L94003, L94004, L94005, L94006, L94007 (1 SET). SIX SETS. WE EXAMINED OUR LOAN SETS (6) AND FOUND MANY HAD THIS DEBRIS, THESE HAVE ALL BEEN CLEANED AND REMAIN IN CIRCULATION. THEY ARE NOW INSPECTED WHEN THEY RETURN TO OUR FACILITY, AND NONE HAVE BEEN FOUND TO HAVE FURTHER DEBRIS BUILD UP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7493971 ↗
• MalfunctionMay 8, 2018Metal Shedding Debris; Metal Shedding Debris

  WE EXAMINED OUR LOAN SETS (6) AND FOUND MANY HAD THIS DEBRIS. PRODUCT CODES L94003, L94004, L94005, L94006, L94007 (1 SET). SIX SETS. WE EXAMINED OUR LOAN SETS (6) AND FOUND MANY HAD THIS DEBRIS, THESE HAVE ALL BEEN CLEANED AND REMAIN IN CIRCULATION. THEY ARE NOW INSPECTED WHEN THEY RETURN TO OUR FACILITY, AND NONE HAVE BEEN FOUND TO HAVE FURTHER DEBRIS BUILD UP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7493808 ↗
• MalfunctionMay 7, 2018Metal Shedding Debris; Metal Shedding Debris

  WE EXAMINED OUR LOAN SETS (6) AND FOUND MANY HAD THIS DEBRIS. (B)(4). SIX SETS. WE EXAMINED OUR LOAN SETS (6) AND FOUND MANY HAD THIS DEBRIS, THESE HAVE ALL BEEN CLEANED AND REMAIN IN CIRCULATION. THEY ARE NOW INSPECTED WHEN THEY RETURN TO OUR FACILITY, AND NONE HAVE BEEN FOUND TO HAVE FURTHER DEBRIS BUILD UP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7490297 ↗
• MalfunctionMay 4, 2018Metal Shedding Debris; Metal Shedding Debris

  WE EXAMINED OUR LOAN SETS (6) AND FOUND MANY HAD THIS DEBRIS. (B)(4). SIX SETS. WE EXAMINED OUR LOAN SETS (6) AND FOUND MANY HAD THIS DEBRIS, THESE HAVE ALL BEEN CLEANED AND REMAIN IN CIRCULATION. THEY ARE NOW INSPECTED WHEN THEY RETURN TO OUR FACILITY, AND NONE HAVE BEEN FOUND TO HAVE FURTHER DEBRIS BUILD UP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7488294 ↗