CORAIL L971114Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295455332), received between Feb 26, 2020 and Nov 13, 2024 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2024Adverse 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 INFECTED THA. REMOVED PARTS AND IMPLANTED A PROSTALAC 200M STEM. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20672469 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. DOR: (B)(6) 2023, 25 SEP 2023. DOI: (B)(6) 2023. RIGHT HIP. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING: --> UNKNOWN. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> , 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, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (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: Unspecified Infection

  MAUDE report 18093098 ↗
• InjuryJan 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FIRST INTENTION HIP RIGHT. AT THE BEGINNING IT WAS A CUSTOM HIP DOESN¿T WORK. SECOND TIME THEY DECIDED TO GO ON CORAIL FIRST WITH A 14 COLLARED. AFTER THAT THEY DECIDED TO TAKE A CORAIL 16 CEMENTED. WRONG WAY OUT OF THE FEMUR.

  Patient problems: Limb Fracture

  MAUDE report 16239512 ↗
• InjuryDec 8, 2021Osseointegration Problem; Osseointegration Problem

  REVISION OF THE HIP DUE TO DISLOCATION AND LOOSENING. PATIENT DISLOCATED AND RETURNED BACK TO THE HOSPITAL, WHILE BEING RELOCATED BACK INTO POSITION A GT FRACTURE OCCURRED WHICH THEN ENABLED THE STEM TO LOOSEN IN THE FEMORAL CANAL. ORIGINAL SURGERY WAS DONE ON THE (B)(6) 2021 AT (B)(6) HOSPITAL BY DR. (B)(6). THE SIDE WAS THE RIGHT SIDE THAT HAS BEEN AFFECTED.

  Patient problems: Inadequate Osseointegration; Limb Fracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12961426 ↗
• MalfunctionAug 11, 2020Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem; Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem

  PROCEDURE: PRIMARY TOTAL HIP REPLACEMENT OPERATING SIDE: LEFT HIP. SURGICAL DELAY: YES, 5 MINS FOR REPLACEMENT IMPLANT TO BE TAKEN FROM IMPLANT ROOM, CHECKED AND OPENED. EVENT: PUNCTURED INNER PACKAGING OF CORAIL STEM. UPON REMOVAL OF THE INNER PACKAGING OF THE CORAIL STEM FROM ITS OUTER BOX IT WAS EVIDENT THAT THERE WAS A DISTINCTIVE HOLE BETWEEN THE PAPER SEAL AND THE PLASTIC BOX CONTAINING THE STERILE IMPLANT. ON CLOSER EXAMINATION IT WAS CLEAR THAT THIS HOLE HAD PUNCTURED ALL THE WAY THROUGH THE PAPER THEREFORE DEEMING THE IMPLANT CONTAINED WITHIN THE PLASTIC BOX UNSTERILE. ANOTHER IMPLANT WAS OPENED AND USED IN ITS PLACE.

  Patient problems: No Code Available

  MAUDE report 10390909 ↗
• InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SPASM WITH MOVEMENT. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2019, (LEFT HIP). TREATMENT: UNSPECIFIED MEDICAL INTERVENTION AND UNSPECIFIED SURGICAL INTERVENTION, (NOT REVISION).

  Patient problems: Muscle Spasm(s); No Code Available

  MAUDE report 9757228 ↗