CORAIL L971212Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295478638), received between Jun 22, 2021 and Jul 29, 2026 — classified as 3 injuries, 2 malfunctions.

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

• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to pain. Affected Side: Right.

  Patient problems: Pain

  MAUDE report 50069193 ↗
• MalfunctionMar 27, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? -YES 30 MIN. B. WAS THERE ANY PATIENT CONSEQUENCE RELATED TO THE EVENT? -THERE WAS NO CONSEQUENCE FOR THE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18987107 ↗
• MalfunctionJun 1, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON PREPARED THE CANAL FOR A CORAIL 125 DEGREE STANDARD COLLAR CORAIL SIZE 12 . THE SURGEON BROACHED PROGRESSIVELY TO SIZE 12 AND TOOK X-RAYS . THE SURGEON USED A CALCAR PLANER AND EVERYTHING LOOKED GOOD . HOWEVER UPON INSERTING THE STEM IT WOULD NOT SEAT FLUSH TO THE CALCAR AND WAS 7 CENTIMETERS PROUD WHICH IS UNACCEPTABLE . THE SURGEON IS A PARTICIPANT IN DOTS WITH DEPUY CLINICAL ORTHOPEDICS . A GREAT DEAL OF THE INFORMATION AM BE OBTAINED FROM THEM. THERE IS NO REPORTED LOOSENING. THERE IS A REPORTED SURGICAL DELAY OF 5 MINUTES. DOE: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14566047 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 14186590 ↗
• InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED IN SURGEONS OFFICE WITH PAINFUL LEFT HIP AND REDNESS. SURGEON ORDERED SERUM TESTING FOR INFECTION AND IT CAME BACK POSITIVE. SURGEON ELECTED TO PERFORM A SINGLE STAGE REVISION ON (B)(6) AT (B)(6) HOSPITAL. SURGEON REMOVED PRIMARY COMPONENTS USING DEPUY STANDARD INSTRUMENTS. SURGEON THEN PROCEEDED WITH HIS PROTOCOL FOR INFECTION TREATMENT. SURGEON THEN ELECTED TO IMPLANT NEW COMPONENTS AND CONTINUE TO TREAT THE PATIENT FOR INFECTION. NO COMPONENTS BROKE DURING THE CASE. THERE WAS NO MENTION BY ANYONE THAT THE COMPONENTS CONTRIBUTED TO THE EVENT. THERE WERE NO TIME DELAYS. INDEX SURGERY HAPPENED ON (B)(6) 2021 AT (B)(6) HOSPITAL BY THE SURGEON.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 12042697 ↗