CORAIL 3L92506Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295168720), received between Nov 21, 2017 and May 29, 2026 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION AND FRACTURE OF HEMI. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 25334199 ↗
• InjuryJul 16, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING. THERE WAS CORAIL STEM LOOSENING AT NON-CEMENTED INTERFACE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22518795 ↗
• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PULLED CORAIL/PINNACLE TOTAL HIP WAS REMOVED AND A PROSTALAC WAS IMPLANTED FOR INFECTION. THERE WAS NO IMPLANT FAILURE, THERE WAS NO DELAY, NO BROKEN INSTRUMENTS AND NO OTHER INFORMATION KNOWN. DOI: UNKNOWN . DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19575530 ↗
• InjuryJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE : RIGHT HIP.

  Patient problems: Pain

  MAUDE report 17144597 ↗
• InjuryNov 7, 2022Difficult to Remove; Difficult to Remove

  CLINICAL ADVERSE EVENT RECEIVED FOR ADVERSE LOCAL TISSUE REACTION AROUND PROSTHESIS. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2010. DATE OF REVISION: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (LEFT HIP) TREATMENT: REVISION; LINER WAS REVISED.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Pain; Swelling/ Edema

  MAUDE report 15742760 ↗
• MalfunctionMar 25, 2020Expiration Date Error; Expiration Date Error

  ON (B)(6) 2020 CUSTOMER SERVICE (MD PL ) RECEIVED CONFIRMED INFORMATION THAT EXPIRED JOINTS PRODUCT FROM CONSIGNMENT STOCK HAS BEEN USED IN (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9880063 ↗
• InjuryJan 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATING THAT THE AFFECTED SIDE IS THE RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9628977 ↗
• InjuryMay 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR LEFT HIP REVISION TO ADDRESS ADVERSE LOCAL TISSUE REACTION.

  Patient problems: No Code Available; Pain; Tissue Damage

  MAUDE report 8649305 ↗
• InjuryMar 12, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT THA PERFORMED ON (B)(6) 2019 FOR A FEMORAL NECK FRACTURE. ON (B)(6) 2019, THE PATIENT HAD HEARD A SNAP WHEN DOING PHYSICAL THERAPY AND NOW HAD A PERIPROSTHETIC FRACTURE WHICH HE WANTED TO REVISE ON (B)(6) 2019. THE SURGEON HAD DONE THE PRIMARY SURGERY THROUGH THE ANTERIOR APPROACH AND WANTED TO DO THE SAME FOR THE REVISION USING RECLAIM. THE SURGEON REMOVED THE CORAIL STEM AND IMPLANTED THE RECLAIM STEM AND WAS HAPPY WITH HIS LEG LENGTHS AND OFFSET. THE SURGEON MENTIONED THAT DURING THE PRIMARY SURGERY, THE PATIENT HAD VERY BAD BONE, AND HE SUSPECTS WHEN BROACHING OR CALCAR REAMING HE MIGHT HAVE FRACTURED THEN, WITHOUT REALIZING IT. IT WAS ALSO INDICATED THAT THERE WAS A LOOSENING OF THE FEMORAL COMPONENT AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8412640 ↗
• InjuryAug 29, 2018Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF FEMORAL STEM AT BONE TO IMPLANT INTERFACE AND A RETROVERTED CUP. THE SURGEON REMOVED ALL COMPONENTS. DOI: (B)(6) 2017; DOR: (B)(6) 2018; UNKNOWN HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7826048 ↗
• InjuryDec 18, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES FOR PROXIMAL HIP FRACTURE OF THE BONE. DOI: (B)(6) 2017, DOR: (B)(6) 2017, LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 7125100 ↗
• InjuryNov 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT PATIENT HAD AN I&D AND REPLACED UNIPOLAR BALL AND SPACER ON (B)(6) 2017. TODAY, ALL COMPONENTS WERE REMOVED DUE TO INFECTION. A BIOMET ANTIBIOTIC HIP SPACER WAS PUT IN.

  Patient problems: Unspecified Infection

  MAUDE report 7048063 ↗