CORAIL L94003Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295325147), received between Oct 10, 2017 and Jul 3, 2025 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Metal Shedding Debris” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 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 22396496 ↗
• MalfunctionJul 6, 2022Unintended Movement; Unintended Movement

  CORAIL 125 SHORT NECK STANDARD NECK TRIAL RING IS LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14931350 ↗
• MalfunctionJan 22, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT IS WORN AND NEEDS REPLACING. SHIP TO (B)(6) FOR P1 DELIVERY VIA (B)(6). NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11216679 ↗
• MalfunctionNov 19, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TRUNION WAS WORN AND NEEDS TO BE REPLACED. SHIP REPLACEMENT P1 TO EAST COOPER. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10871313 ↗
• MalfunctionOct 1, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE CORAIL AMT NECK SEG 125D STD WAS STRETCHED OUT. THE HIP BALL TRIAL WAS HARD TO GET TO FULLY SEAT. THERE WAS NO SURGICAL DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10613016 ↗
• 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 9741106 ↗
• MalfunctionNov 26, 2019Connection Problem; Device-Device Incompatibility; Naturally Worn; Connection Problem; Device-Device Incompatibility; Naturally Worn

  THE TRUNION OF THE COXA VERA NECK TRIAL WAS DAMAGED AND WOULD NOT ACCEPT THE HEAD TRIAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9376477 ↗
• MalfunctionDec 6, 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 8137432 ↗
• MalfunctionOct 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DAMAGED INSTRUMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7968945 ↗
• 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 7955630 ↗
• 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 7955611 ↗
• 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 7901795 ↗
• MalfunctionSep 13, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 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 7872817 ↗
• MalfunctionSep 13, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 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 BEING THE RUBBER RING, WHICH HOLDS THE TRIAL NECK TO THE FEMORAL BROACH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7872563 ↗
• 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 7813910 ↗
• 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 7493929 ↗
• 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 7493928 ↗
• 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 7490527 ↗
• 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 7490279 ↗
• 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 7487920 ↗
• 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 7487591 ↗
• MalfunctionOct 10, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CORAIL NECK SEGMENT 125 STANDARD OFFSET WAS FOUND DIFFICULT TO ATTACH TO CORAIL BROACH.

  Patient problems: No Information

  MAUDE report 6935908 ↗