CORAIL L94006Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10603295325178), received between Apr 24, 2018 and Dec 8, 2025 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT AFTER A SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CALCAR REAMER WAS VERY DAMAGED THE STATE OF THE PATIENT IS UNKNOWN. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? --> UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23745037 ↗
• MalfunctionNov 4, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING SURGERY, THE METAL RETAINING RING ON THE CORAIL HO 135 NECK SEGMENT IS NOT SITTING FLUSH MAKING USE OF TRIAL HEADS DIFFICULT. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23466466 ↗
• 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 22396491 ↗
• MalfunctionMay 14, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE CORAIL TRIAL KHO NECK RING IS BENT, UNABLE TO INSERT ONTO TRIAL HEAD DURING SURGERY. THE PROCEDURE WAS NOT DELAYED; THE TRIAL HEAD WAS ABLE TO BE INSERTED WITH GREAT FORCE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO IMPACT ON THE CASE OR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22017490 ↗
• MalfunctionMar 10, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 135DEG HIGH OFFSET NECK TRIAL WAS NOT CONNECTING TO THE TRIAL HEADS. REPLACEMENT ARE REQUIRED. THERE WERE NO FRAGMENTS CREATED, 1MINUTE DELAY IN SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21559191 ↗
• MalfunctionJan 28, 2025Break; Entrapment of Device; Detachment of Device or Device Component; Break; Entrapment of Device; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED: WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO DELAY IT WAS FOUND IN THE SCRUB ROOM BEFORE THE NEXT SURGERY HAD COMMENCED. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? UNSURE, ALL SURGEONS WITH PATIENTS THIS SET HAS BEEN USED IN THE PAST MONTH HAVE BEEN NOTIFIED THAT THERE IS A CHANCE THE MISSING PIECE OF THE INSTRUMENT IS IN A PATIENT.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 21254439 ↗
• MalfunctionAug 22, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE O RING ON THE CORAIL HIGH OFFSET NECK TRIALS WAS DEFORMED AND MADE IT DIFFICULT TO ATTACH TRIAL HEADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597050 ↗
• MalfunctionDec 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON TRIED TO ATTACH A NECK TRIAL(135HO) INTO THE BROACH, BUT IT DID NOT GO SMOOTHLY. THE SURGEON STRUCK THE NECK TRIAL WITH A HAMMER, AND HE MANAGED TO ATTACH IT, BUT COULDN¿T REMOVE THE NECK TRIAL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 15 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13117414 ↗
• MalfunctionJan 5, 2021Material Integrity Problem; Material Integrity Problem

  NURSE AT HOSPITAL CONTACTED VIA TEXT MESSAGE TO INFORM THAT ONE OF THEIR CORAIL NECK TRIAL PIECES HAD A DAMAGED LOCKING RING. NO INFORMATION PROVIDED AROUND CASE DETAILS WHEN INITIALLY REPORTED. NO ADVERSE EVENT. NO FURTHER INFORMATION AVAILABLE. PRODUCT THEN RECEIVED AND INVESTIGATION PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11120208 ↗
• MalfunctionJan 5, 2021Use of Device Problem; Use of Device Problem

  SMALL METAL RING NOTICED TO BE MISSING ON KHO NECK TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11118548 ↗
• MalfunctionFeb 21, 2020Device-Device Incompatibility; Device-Device Incompatibility

  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 9741120 ↗
• MalfunctionDec 27, 2019Material Twisted/Bent; Material Twisted/Bent

  DAMAGED ATTUNE CR 6R FEMORAL TRIAL, SZ 3-4 12MM SHIM, CORAIL STD 135 DEGREE NECK TRIAL AND CORAIL KHO 135 DEGREE NECK TRIAL. REPORTED WORN AND DAMAGED IN CSSD BY CSSD STAFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9524774 ↗
• MalfunctionFeb 12, 2019Break; Material Deformation; Break; Material Deformation

  LOCKING RING ON THE NECK SEGMENT SNAPPED AND HEAD TRIALS WILL NO LONGER SNAP ON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8332386 ↗
• MalfunctionDec 21, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8190198 ↗
• MalfunctionDec 10, 2018Device Damaged Prior to Use; Device Contamination with Chemical or Other Material; Device Damaged Prior to Use; Device Contamination with Chemical or Other Material

  BLACK STAIN ON THE PRODUCT. WHEN HOSPITAL TRIED TO REMOVE THE STAIN SOME KIND OF METAL CAME OUT. DISCOVERED BEFORE SURGERY. DID NOT COME OFF WHEN TRYING TO CLEAN IT. HOSPITAL DID NOT WANT TO USE THE PRODUCT BECAUSE OF THIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8146103 ↗
• 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 8054728 ↗
• 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 7955764 ↗
• 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 7955745 ↗
• MalfunctionOct 4, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CORAIL NECK SEGMENTS NOT SITTING ON BRANCHES PROPERLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7936017 ↗
• 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 7901753 ↗
• MalfunctionSep 17, 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 7880330 ↗
• 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 7872841 ↗
• 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 7814090 ↗
• MalfunctionAug 3, 2018Break; Break

  (B)(6), (B)(6) 2018: THE METAL O-RING ON NECK TRIAL DISENGAGED AND WAS NOT ALLOWING HEAD TRIAL TO CLIP IN PLACE. BROKEN OFF PIECE ACCOUNTED FOR. THE SURGEON UNDERWENT A TRIAL REDUCTION WITH NECK AND HEAD, WITHOUT THIS METAL RING IN INSITU. MALE PATIENT ID: (B)(6), AGED (B)(6) YEARS, DOB: (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7748202 ↗
• MalfunctionJul 5, 2018Material Separation; Material Separation

  AFTER REMOVAL OF O-RING AS PER FSCA CORAIL - PIE-1125109 THE TRIAL NECK AND THE TRIAL STEM ARE DISASSEMBLING/SEPARATING WITHOUT ANY FORCES. THIS DID NOT HAPPEN INTRAOPERATIVELY, NO ADVERSE CONSEQUENCES FOR ANYBODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7663852 ↗