CORAIL 3L92508Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295168744), received between Feb 27, 2018 and May 10, 2022 — classified as 5 injuries, 1 malfunction.

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.

• InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION WAS COMPLETED TO ADDRESS INFECTION. NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14348081 ↗
• InjuryMar 8, 2022Osseointegration Problem; Osseointegration Problem

  REVISION COMPLETED DUE TO PAIN AND LOOSENING OF THE FEMORAL STEM AT THE BONE TO IMPLANT INTERFACE. DOI UNKNOWN, DOR: (B)(6) 2022, LEFT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 13694508 ↗
• InjuryMar 8, 2022Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO PAIN AND LOOSENING OF THE FEMORAL STEM AT THE BONE TO IMPLANT INTERFACE. DOI: UNKNOWN, DOR: (B)(6) 2022. AFFECTED SIDE : LEFT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 13693106 ↗
• InjuryFeb 25, 2021Use of Device Problem; Use of Device Problem

  THE REASON FOR REVISION WAS DUE TO SURGEON ERROR IN INCORRECTLY POSITIONING THE STEM THROUGH THE FEMUR. THERE ARE NO X-RAYS AND NO OTHER DATA WILL BE PROVIDED BY THE REVISING SURGEON. THE REVISING SURGEON DOES NOT REQUIRE ANY FOLLOW UP.

  Patient problems: Insufficient Information

  MAUDE report 11377780 ↗
• MalfunctionJul 9, 2019Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT THE SURGEON DID A PRIMARY HIP AND USUALLY USES ACTIS. THIS PATIENT HAD OTHER SIDE DONE WITH A CORIAL, SO THE SURGEON WANTED TO MATCH UP THE OTHER SIDE AND USE CORAIL. THE SURGEON BROACH UP TO AN 18 CORAIL AND TRIALED A STANDARD NECK. HE WANTED THE CORAIL KA 18 STEM OPENED, BUT IT WAS EXPIRED ON 2019-03. I TOLD THE SURGEON IT WAS EXPIRED AND GAVE HIM OTHER OPTIONS, HE TOLD ME TO OPEN THE EXPIRED IMPLANT BECAUSE THAT¿S WHAT HE WANTED, KNOWING IT WAS EXPIRED BEFORE HAND. SO THE NURSE OPENED THE STEM UP TO THE FIELD AND THE DR USED IT. DOE: (B)(6) 2019, LEFT HIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8772781 ↗
• InjuryFeb 27, 2018Metal Shedding Debris; Appropriate Device Problem Term/Code Not Available; Metal Shedding Debris; Appropriate Device Problem Term/Code Not Available

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES METAL WEAR/METALLOSIS CONFIRMED IN MEDICAL RECORDS AND ELEVATED METAL IONS CONFIRMED IN MEDICAL RECORDS. CUP WAS ADDED SINCE PPF RECORD INDICATED THAT IT WAS REMOVED.

  Patient problems: Discomfort; Inflammation; Injury; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 7299009 ↗