CORAIL L98011Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295262305), received between Mar 24, 2020 and Mar 20, 2026 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2026Osseointegration Problem

  IT WAS REPORTED THAT THE DOCTOR REVISED DUE TO SIGNS OF LOOSENING OF THE FEMORAL STEM AND POSSIBLE INFECTION. USED OSTEOTOMES TO DISENGAGE AND MULTIPLE DIFFERENT ATTACHMENTS TO BACKSLAP THE STEM. AFTER MANY TRIES, THE THREADED STEM INSERTER'S THREADS BROKE OFF IN THE STEM. HE THEN DID AN ETO TO REMOVE THE STEM. AFFECTED SIDE-LEFT HIP.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 24647944 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON PUT PRIMARY STEM OF THE BACK OF THE FEMUR. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 21969844 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. COMPONENTS WERE REMOVED AND REPLACED WITH A PROSTALAC STEM. NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18257385 ↗
• InjurySep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SZ 11 CORAIL REVISION STEM AND 36 +1.5 CERAMIC HEAD WERE EXPLANTED DUE TO STEM PERFORATING LATERAL CORTEX OF FEMUR. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 17787623 ↗
• MalfunctionAug 31, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  A MODULE WAS RECEIVED WITH WHAT IS BELIEVED TO BE A BLOODY STERILE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17660675 ↗
• InjuryJan 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PERIPROSTHETIC FRACTURE FEMORAL. EVENT IS PROBABLY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021. DATE OF REVISION: (B)(6) 2021. (LEFT HIP) TREATMENT: REVISION OF THE STEM AND HEAD ON (B)(6) 2021.

  Patient problems: Limb Fracture

  MAUDE report 13398188 ↗
• InjurySep 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE REVISION SURGERY. FOR THIS PATIENT¿S BONE FRACTURE, THE STEM HAD BEEN USED AS REPORTED IN (B)(4). ON (B)(6), FOR MAINTAINING THE CONTINUITY OF THE BONE, THE REVISION SURGERY WAS PERFORMED, AND THE STEM WAS REPLACED WITH ANOTHER PRODUCT (ZIMMER BIOMET¿S ¿OSS¿). DOI: (B)(6) 2018, DOR: (B)(6) 2021, UNKNOWN SIDE.

  Patient problems: Bone Fracture(s)

  MAUDE report 12521200 ↗
• InjurySep 11, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE SURGERY WAS SCHEDULED ON (B)(6) 2020 DUE TO THE BREAKAGE OF THE STEM WHICH WAS REVISED AT THE REVISION SURGERY ON (B)(6) 2020. THE SURGEON PLANNED TO REMOVE THE BROKEN DISTAL END OF THE STEM AND PERFORM ORIF, OR TO REMOVE ALL OF THE STEM. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 10521467 ↗
• InjuryMar 30, 2020Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  ACCORDING TO THE SURGEON, THE DECISION TO REVISE WAS TAKEN BECAUSE THE PATIENT HAD PAIN AND ON THE X-RAY, THE CORAIL SIZE 11 SEEMED TO BE LOOSE. DURING THE SURGERY, THE CUP WAS FOUND TO BE WELL FIXED AND THE CORAIL STANDARD STEM SIZE 11 WAS LOOSE AND IT WAS REMOVED AND REPLACED WITH AN CORAIL REVISION SIZE 15 (L98015) AND A CERAMIC HEAD SIZE 36 +5 (136536320). .

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 9897782 ↗
• MalfunctionMar 24, 2020Fracture; Fracture

  THE SURGEON SENT ME THE X-RAYS OF A HIP REPLACEMENT THAT HE NEEDS TO REVIEW BECAUSE THE PATIENT IS IN GREAT PAIN. THEN HE CALLED ME TO FIX THE DATE OF THE REVISION AND THEN HE ASKED ME IF I NOTICED THAT THE STEM WAS FRACTURED IN 2 PLACES. THERE HAS BEEN NO SURGICAL INTERVENTION AND/OR INVASIVE TREATMENT PERFORMED.

  Patient problems: No Code Available; Pain

  MAUDE report 9872450 ↗