CORAIL L971113Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295455325), received between Oct 22, 2019 and May 19, 2026 — classified as 13 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (4 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION OF CORAIL STEM FOLLOWING PPFX. DOI- (B)(6) 2022, DOR- (B)(6) 2026, AFFECTED SIDE-LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 25222283 ↗
• MalfunctionJan 6, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT WHEN ONE CORAIL IMPLANT WAS REMOVED TO PLACE INSIDE THE PATIENT, A NURSE OBSERVED A DARK PATCH ON ITS "NECK". THAT IMPLANT WAS SET ASIDE AND A SECOND IMPLANT WHICH WAS HARDER TO OPEN WAS USED INSTEAD. AFTER THE OPERATION THE DARK PATCH WAS NO LONGER VISIBLE, AND STAFF BELIEVE IT WAS HUMIDITY THAT DRIED WHILE THE IMPLANT SAT ON THE TABLE. NO PHOTOGRAPHS WERE TAKEN BECAUSE THE PATIENT WAS ALREADY ON THE TABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23976932 ↗
• InjuryMar 12, 2025Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. IT WAS ALSO REPORTED THAT PATIENT SUFFERED PERIPROSTHETIC FRACTURE AFTER A FALL. REVISED STEM AND HEAD FROM RIGHT TOTAL HIP. NO SURGICAL DELAY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 21586659 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 21355064 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LEFT THA REVISION FOR SEPTIC ARTHRITIS. DOI: (B)(6) 2024, DOE: (B)(6) 2024, AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 19484584 ↗
• MalfunctionApr 10, 2024Incomplete or Missing Packaging; Manufacturing, Packaging or Shipping Problem; Incomplete or Missing Packaging; Manufacturing, Packaging or Shipping Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT HARM/CONSEQUENCE RELATED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19077945 ↗
• InjuryMar 7, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD TOTAL HIP REPLACEMENT IN SUMMER OF 2023. THE PATIENT CALLED THE SURGEON'S OFFICE AS THEY STARTED HAVING INCREASED PAIN. THE SURGEON COMPARED OLD X RAYS TO NEW X RAYS AND STEM ASSUMES TO BE LOOSE. DURING THE SURGERY THAT THOUGHT WAS CONFIRMED. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 18857974 ↗
• InjuryAug 21, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE CORAIL STEM SUBSIDED AND PATIENT WAS INFECTED SO ALL PARTS EXPLANTED. THERE WAS A LOOSENING AT THE NON-CEMENTED INTERFACE. THERE WAS NO SURGICAL DELAY. DOI: ON (B)(6) 2022, DOR: ON (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 17586176 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION OF RIGHT TOTAL HIP REPLACEMENT. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15649460 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A TRAUMATIC INJURY RESULTING IN A PERIPROSTHETIC FRACTURE. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 14186473 ↗
• InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR WORSENING OF PRE-EXISTING CONDITION - ANEMIA. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2021, DATE OF EVENT: (B)(6) 2021, (LEFT HIP). TREATMENT: TRANSFUSION 1 UNIT OF BLOOD.

  Patient problems: Anemia

  MAUDE report 12831632 ↗
• InjuryApr 26, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND FRACTURED FEMUR RESULTING IN A LOOSE STEM AT THE BONE TO IMPLANT INTERFACE. HIP COMPONENTS WERE EXPLANTED AND REPLACED WITH NEW REVISION IMPLANTS. THERE WERE NO DEFICIENCIES NOTED WITH THE PRODUCTS. IMPLANTS ARE NOT AVAILABLE FOR RETURN. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2021, UNKNOWN AFFECTED SIDE.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 11724772 ↗
• InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS STATED THAT THE PATIENT FELL, PERIPROSTHETIC FRACTURE AROUND HIS FEMORAL STEM. DOI: (B)(6) 2020. DOR: (B)(6) 2020. LEFT HIP.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 11127002 ↗
• InjuryApr 16, 2020Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration

  ADDITIONAL INFORMATION STATED THAT IT APPEARED THAT THE AFFECTED SIDE IS THE RIGHT SIDE, BY LOOKING AT THE X-RAYS. IT STATED LEFT IN THE DESCRIPTION. THE FRACTURE OF THE STEM, AS INDICATED BY THE CLINICAL NOTE, WAS NOT CONFIRMED BY THE X-RAY REVIEW. THERE IS NO STEM FRACTURE IDENTIFIED, ONLY PATIENT BONE.

  Patient problems: Bone Fracture(s); Edema; Hematoma; Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 9967828 ↗
• MalfunctionFeb 26, 2020Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  EVENT: PUNCTURED INNER PACKAGING . UPON REMOVAL OF THE INNER PACKAGING FROM THE OUTER BOX IT WAS NOTED BY THE CIRCULATING NURSE THAT THERE WAS A HOLE IN THE TOP COVERING OF THE PACKAGE CONTAINING THE STERILE IMPLANT. NO EVIDENT DAMAGE TO THE OUTER BOX COULD BE SEEN TO EXPLAIN THIS EVENT. THE CLEAR PLASTIC FILM ON THE OUTER BOX WAS ALSO UNDAMAGED. AS THE HOLE WAS IN THE PACKAGE PROTECTING THE STERILE IMPLANT IT WAS DEEMED APPROPRIATE NOT TO USE THIS IMPLANT AND ANOTHER ONE WAS OPENED AND USED IN ITS PLACE.

  Patient problems: Insufficient Information; No Consequences Or Impact To Patient

  MAUDE report 9757222 ↗
• InjuryOct 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEG LENGTH WAS TOO LONG. DOI: (B)(6) 2019, DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 9220234 ↗