CORAIL L94007Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295325185), received between May 4, 2018 and Jul 3, 2025 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• 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 22396487 ↗
• MalfunctionJun 24, 2025Break; Break

  IT WAS REPORTED THAT THERE WERE BROKEN INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318361 ↗
• MalfunctionJan 29, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT TRIAL WAS NOT SITTING ON THE THE BROACH TRIAL. THIS EVENT DIDN'T HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596131 ↗
• MalfunctionJan 19, 2023Naturally Worn; Illegible Information; Naturally Worn; Illegible Information

  ADDITIONAL INFORMATION RECEIVED. INDICATED, THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16205549 ↗
• MalfunctionMar 21, 2021Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem

  COMPLAINT FROM STERILE DEPARTMENT, CORROSION ON CE MARKING OR NUMBERS. LOOKS LIKE CORROSION ON MARKINGS, BROWNISH COLOR! NO NEW PROCEDURES IN STERILE DEPART, NO NEW CHEMICALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11536928 ↗
• MalfunctionMar 21, 2021Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem

  COMPLAINT FROM STERILE DEPARTMENT, CORROSION ON CE MARKING OR NUMBERS. LOOKS LIKE CORROSION ON MARKINGS, BROWNISH COLOR! NO NEW PROCEDURES IN STERILE DEPART, NO NEW CHEMICALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11536927 ↗
• MalfunctionJan 22, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT TRUNION IS WORN AND NEEDS REPLACING. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11216691 ↗
• MalfunctionNov 19, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TRUNION WAS WORN AND NEEDS TO BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10871294 ↗
• 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 9741116 ↗
• MalfunctionNov 6, 2019Device-Device Incompatibility; Device-Device Incompatibility

  TRIAL HEAD ISN'T STAYING ON TRUNION. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9284861 ↗
• MalfunctionSep 24, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT FITTING FAILURE OF THE HEAD TRIAL (P/N: 253091000) AND THE NECK SEGMENT (P/N: L94007) DURING THE THA OF THE PATIENT¿S RIGHT HIP JOINT ON (B)(6) 2019. THE SURGEON ATTEMPTED TO ATTACH THEM, HOWEVER IT WAS TOO HARD TO FIT. THE NECK SEGMENT WAS SEPARATED AND REMOVED FROM THE OPERATIVE FIELD, AND THE DOCTOR MANAGED TO ATTACH THE HEAD TRIAL AND THE NECK SEGMENT WITH BOTH HANDS, AND IT WAS ABLE TO FIT FINALLY. IN ADDITION, TO SEPARATE THEM WAS NOT ALSO EASY. THE SURGERY WAS COMPLETED WITHIN A 30 MINUTES SURGICAL DELAY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Not Applicable

  MAUDE report 9109516 ↗
• 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 8190205 ↗
• 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. REMAINING RINGS ON ALL OTHER TRIALS IN THE SET ARE LOOSE AND AT RISK OF EITHER FALLING OFF IN FUTURE CASES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8054750 ↗
• MalfunctionOct 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DAMAGED INSTRUMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7968916 ↗
• 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 7955829 ↗
• 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 7955810 ↗
• 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 7901776 ↗
• MalfunctionSep 18, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  CUSTOMER REPORTS: WHILE I WAS CHECKING A SET WITH THE SCRUB NURSE BEFORE A PROCEDURE, I NOTICED THAT THERE APPEARED TO BE DEBRIS ATTACHED TO THE O RING IN THE CHANNEL OF THE NECK TRIAL. I REMOVED THE KIT AND OPENED A SECOND KIT WHICH WAS CLEAN. I REMOVED THE O RING AND SURE ENOUGH THERE WAS SOME DEBRIS UNDERNEATH THE O RING AS WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7886565 ↗
• 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 7872917 ↗
• 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 7872880 ↗
• 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 7813899 ↗
• 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 7494328 ↗
• 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 7494021 ↗
• 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 7493861 ↗
• MalfunctionMay 7, 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 7490502 ↗