CORAIL L971310Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295455448), received between Jul 31, 2018 and Jan 30, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Fitting 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2019; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 9648522 ↗
• InjuryAug 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WHEN SONICING A CHAMBER PROTESIS RECOVERED IN (B)(6) HOSPITAL, IT HAS APPEARED A STRAIN INFECTION, A MICOSIS, THE (B)(6) HOSPITAL HAS HAPPENED AND BY COMMANDING THE (B)(6) CHECKED THAT THEY ALSO HAD THE SAME INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8908348 ↗
• InjuryJul 31, 2018Fitting Problem; Fitting Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2018 VIA THA. TWO WEEKS AFTER THE PRIMARY SURGERY, THE SURGEON RECOGNIZED THAT THE STEM WAS ROTATED IN THE MEDULLARY CAVITY, SO THAT THE IT WAS DISLOCATED. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2018. THE SURGEON COMMENTED THAT THE SIZE OF THE STEM WHICH INITIALLY IMPLANTED MIGHT HAVE BEEN UNDER SIZED.

  Patient problems: Not Applicable

  MAUDE report 7734584 ↗