CORAIL L98012Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295262312), received between Aug 21, 2023 and Sep 23, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Fracture” (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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, the patient underwent revision surgery with the product in question. A patient who had previously underwent implantation of a Corail Revision stem following TFNA removal presented with a distal femoral fracture. As there was also some degree of dislocation, stem replacement was considered. Consequently, revision surgery was performed on the same day and the Corail Revision stem was removed, and the longest Arcos stem and neck component were implanted. The surgery was completed successfully without any delay. No further information is available.This report is related to complaint (b)(4)which captures the revision surgery of the TFNA.

  Patient problems: Limb Fracture

  MAUDE report 50871421 ↗
• InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTS WITH INFECTION POST REVISION THA. POLY AND HEAD HAD BEEN EXCHANGED ON (B)(6) 2021 BUT DER INFORMATION WAS UNAVAILABLE IN OPTIMIZE. RECORDS IN OPTIMIZE ONLY SHOW THE STEM AS THE MIGRATION FROM COMPASS DID NOT TRANSFER THE OTHER IMPLANTS. ALL COMPONENTS WERE REMOVED AND A PROSTALAC SPACER WAS PLACED WITH NO DELAY OR PATIENT HARM NOTED. NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25485970 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FRACTURED THEIR FEMUR. SIZE 12 STD CORAIL REVISION AND 36+5 DELTA HEAD. IT WAS PERIPROSTHETIC FRACTURE. THE EVENT DID NOT HAPPEN IN SURGERY. DOE: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Limb Fracture

  MAUDE report 24570066 ↗
• InjuryDec 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO A BROKEN CORAIL STEM (RIGHT HIP).

  Patient problems: Insufficient Information

  MAUDE report 20842920 ↗
• InjuryNov 5, 2024Migration; Migration

  IT WAS REPORTED, THAT THE PATIENT WAS REVISED, DUE TO STEM SUBSIDED. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 20614769 ↗
• InjuryDec 18, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED FOR DISLOCATION. COMPONENT REMOVAL RE-IMPLANTATION. ADDITIONAL INFO RECEIVED FROM SALES REP 12/11/2023 -SPOKE WITH SALES REP VIA PHONE TO CLARIFY THE EVENT DESCRIPTION. THE PATIENT WAS REVISED DUE TO GLOBAL INSTABILITY. DURING THE REVISION THE ACETABULAR CUP AND FEMORAL COMPONENT WERE NOTED TO BE LOOSE, NO INTERFACE PROVIDED. THE ORIGINAL IMPLANT DATE WAS (B)(6) 2023 AND REVISION DATE WAS (B)(6) 2023. ALL COMPONENTS WERE REVISED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Joint Laxity

  MAUDE report 18348433 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 17584797 ↗