CORAIL 3L93716Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295168935), received between May 31, 2018 and Aug 17, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION SO THE DOCTOR DID A ONE STAGE REIMPLANTATION WITH NEW COMPONENTS AFTER A COMPLETE WASHOUT. NO SURGICAL DELAY. THERE WAS LOOSENING AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2019, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 15241272 ↗
• InjuryNov 29, 2021Osseointegration Problem; Osseointegration Problem

  PATIENT HAS HAD CHRONIC ONGOING INFECTION, AND THE FEMORAL STEM WAS IDENTIFIED AS BEING LOOSE. THE STEM WAS REMOVED, THE CUP AND LINER WERE REMOVED. DOI: 2016, DOR: (B)(6) 2021, RIGHT SIDE.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 12882122 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PT LT TOTAL HIP REVISED TO PROSTALAC SPACER DUE TO INFECTION. ORIGINAL LEFT TOTAL HIP (B)(6) 2020. NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 12469734 ↗
• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INFECTION. DOI: (B)(6) 2020; DOR: (B)(6) 2021; RIGHT HIP.

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

  MAUDE report 11818880 ↗
• InjuryJan 25, 2019Loss of Osseointegration; Migration; Loss of Osseointegration; Migration

  IT WAS REPORTED THAT THE STEM APPEARS TO BE SLIGHTLY UNDERSIZED, IS LOOSE AT THE BONE TO IMPLANT INTERFACE AND HAS SUBSIDED. 16 KLA CORAIL COLLARED IN A TYPE C FEMUR. FEMUR ALSO EXHIBITS EXTREME FEMORAL BOW. PATIENT COMPLAINING OF PAIN AND LOSS OF LEG LENGTH DUE TO SUBSIDENCE.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8277425 ↗
• InjuryMay 31, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2018; UNKNOWN SIDE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7556390 ↗