CORAIL L971211Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295478621), received between Aug 14, 2020 and May 27, 2026 — classified as 8 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Fracture

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT BILATERAL THA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. TWO YEARS AFTER THE SURGERY, CRACKS AT THE STEM NECKS WERE IDENTIFIED ON RADIOGRAPHIC IMAGING. THE PATIENT IS A BALLET DANCER AND WAS ABLE TO PERFORM BALLET MOVEMENTS, INCLUDING ABDUCTION; HOWEVER, IT WAS REPORTED THAT A SOUND SUGGESTIVE OF IMPLANT IMPINGEMENT OCCURRED WHEN THE HIP WAS BROUGHT TO MAXIMUM ABDUCTION. AT PRESENT, THE PATIENT REPORTS NO PAIN OR FUNCTIONAL ISSUES. NO FURTHER INFORMATION IS AVAILABLE. (B)(4) CAPTURES FOR THE LEFT HIP AND (B)(4) CAPTURES FOR THE RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 25300764 ↗
• InjuryMay 22, 2026Fracture

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT BILATERAL THA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. TWO YEARS AFTER THE SURGERY, CRACKS AT THE STEM NECKS WERE IDENTIFIED ON RADIOGRAPHIC IMAGING. THE PATIENT IS A BALLET DANCER AND WAS ABLE TO PERFORM BALLET MOVEMENTS, INCLUDING ABDUCTION; HOWEVER, IT WAS REPORTED THAT A SOUND SUGGESTIVE OF IMPLANT IMPINGEMENT OCCURRED WHEN THE HIP WAS BROUGHT TO MAXIMUM ABDUCTION. AT PRESENT, THE PATIENT REPORTS NO PAIN OR FUNCTIONAL ISSUES. NO IMPLANTS HAVE BEEN REMOVED.

  Patient problems: Joint Laxity

  MAUDE report 25256840 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S JOINT SPACE WAS INFECTED. THEREFORE, ALL HARDWARE WAS REMOVED. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24086945 ↗
• MalfunctionNov 19, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THERE WAS LABELLING ISSUE ON CORAIL AMT WHERE THE IMAGE ON THE LABEL DIDN¿T HAVE A COLLAR ON THE STEM. (B)(4) IS LINKED TO THE FOLLOWING COMPLAINTS WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23594139 ↗
• MalfunctionSep 23, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THERE WAS LABELLING ISSUE ON CORAIL AMT WHERE THE IMAGE ON THE LABEL DIDN¿T HAVE A COLLAR ON THE STEM. (B)(4) IS LINKED TO THE FOLLOWING COMPLAINTS WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23126866 ↗
• MalfunctionSep 23, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THERE WAS LABELLING ISSUE ON CORAIL AMT WHERE THE IMAGE ON THE LABEL DIDN¿T HAVE A COLLAR ON THE STEM. (B)(4) IS LINKED TO THE FOLLOWING COMPLAINTS WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23126435 ↗
• MalfunctionSep 23, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THERE WAS LABELLING ISSUE ON CORAIL AMT WHERE THE IMAGE ON THE LABEL DIDN¿T HAVE A COLLAR ON THE STEM. (B)(4) IS LINKED TO THE FOLLOWING COMPLAINTS WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23126243 ↗
• MalfunctionSep 23, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THERE WAS LABELLING ISSUE ON CORAIL AMT WHERE THE IMAGE ON THE LABEL DIDN¿T HAVE A COLLAR ON THE STEM. (B)(4) IS LINKED TO THE FOLLOWING COMPLAINTS WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23126160 ↗
• MalfunctionSep 23, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THERE WAS LABELLING ISSUE ON CORAIL AMT WHERE THE IMAGE ON THE LABEL DIDN¿T HAVE A COLLAR ON THE STEM. (B)(4) IS LINKED TO THE FOLLOWING COMPLAINTS WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23125932 ↗
• MalfunctionSep 23, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THERE WAS LABELLING ISSUE ON CORAIL AMT WHERE THE IMAGE ON THE LABEL DIDN¿T HAVE A COLLAR ON THE STEM. (B)(4) IS LINKED TO THE FOLLOWING COMPLAINTS WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23125384 ↗
• MalfunctionJul 17, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE PICTURE ON L971211 SHOWS A COLLARLESS STEM, WHEREAS IT SHOULD SHOW A COLLARED STEM AS PER THE L971214 EXAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532553 ↗
• InjuryJan 14, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE ORIGINAL SURGERY WAS DONE FOR AN INTERMEDIARY NAIL EXCHANGE. THE DOCTOR NOTATED THAT THE BONE WAS NOT FULLY HEALED BEFORE THE CORAIL STEM WAS PLACED. THE PROXIMAL PORTION OF THE FEMUR FRACTURED AND THE CORAIL STEM SUBSIDED. THE STEM WAS GROSSLY LOOSE AND THE DOCTOR WAS ABLE TO EASILY EXTRACT THE STEM. HE RETAINED THE CUP AND LINER THAT WAS ORIGINALLY PLACED. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Nonunion/Delayed-union Bone Fracture

  MAUDE report 21147838 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVELY, THE PATIENT DEVELOPED A URINARY TRACT INFECTION WHICH HAS MADE THEM VERY ILL. INFECTION IN THE JOINT HAS SINCE DEVELOPED, AS SURGEON NOTED PATIENT HAD BEEN DOING WELL BEFORE THE ABOVE INFECTION. A REVISION OF RIGHT THA DUE TO INFECTION FOLLOWING A DAIR WAS PERFORMED. PATIENT STILL HAD INFECTION AND REQUIRED FIRST STAGE REVISION TO REMOVE ALL COMPONENTS, WASH OUT AND DEBRIDEMENT. CEMENTED A 52 LINER AND SIZE 1 C STEM PLACED FOR APPROXIMATELY 6 WEEKS, AND WILL THEN FULLY REVISE.

  Patient problems: Unspecified Infection

  MAUDE report 21138860 ↗
• InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI- UNKNOWN. DOR- (B)(6) 2022. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Pain

  MAUDE report 14307185 ↗
• InjuryNov 23, 2020Migration; Migration

  REVISION THA: CORAIL PINNACLE REVISED TO C-STEM PINNACLE DUE TO UNDETECTED INTRA-OPERATIVE POSTERIOR CALCAR FRACTURE, RESULTING IN POST-OPERATIVE STEM SUBSIDENCE. CORAIL EXTRACTED, C-STEM IMPLANTED, PINNACLE LINER EXCHANGED DUE TO RANGE OF MOTION INSTABILITY. NO SURGICAL DELAY. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s); Joint Laxity

  MAUDE report 10884979 ↗
• InjuryAug 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 10409572 ↗