CORAIL L98016Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295262350), received between Jan 27, 2020 and May 2, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Osseointegration 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED LEFT HIP. NO SURGICAL DELAY. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21952857 ↗
• InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A REVISION SURGERY AND BHA WITH THE CORAIL REVISION STEM. AFTER REMOVING OTHER COMPANY¿S PRODUCTS WAS REMOVED, THE STEM IN QUESTION WAS INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2025, DISLOCATION OCCURRED. ON (B)(6) 2025, THE PERI-STEM FRACTURE WAS CONFIRMED. ON (B)(6) 2025, THE STEM WAS REMOVED AND REPLACED WITH OTHER COMPANY¿S PRODUCT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Limb Fracture

  MAUDE report 21334084 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS TO REVISED DUE TO PAIN AND IMPINGING ON THE CUP. HE HAD NOT DISLOCATED YET BUT WAS PAINFUL. CUP WAS VERTICAL AND THE STEM WAS UNDERSIZED. CUP AND STEM WERE REMOVED AND REPLACED WITH LARGER SIZE IMPLANTS. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity; Pain

  MAUDE report 20268877 ↗
• InjuryJul 11, 2023Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO LOOSENING. THE PATIENT FELL, LOOSENING THE STEM IN THE FEMUR. DOI: (B)(6) 2023 . DOE: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Inadequate Osseointegration

  MAUDE report 17298697 ↗
• InjuryJan 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORAIL REVISION TOTAL ON (B)(6) 2019, SHE FELL AND FRACTURED HER FEMUR AT THE DISTAL TIP OF THE STEM. THE STEM WAS REVISED TO A RECLAIM CONSTRUCT. DOI: (B)(6) 2019; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9631738 ↗