CORAIL L971309Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295455431), received between Mar 1, 2022 and Dec 31, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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.

• InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A THA FOR LEFT HIP JOINT OA. THE PROCEDURE PROCEEDED WITH THE REGULAR TECHNIQUE. HOWEVER, ACETABULAR REAMING WAS SHALLOW, AND SUFFICIENT FIXATION OF THE CUP WAS NOT ACHIEVED. THERE WAS A CRACK IN THE FEMUR FOR THE STEM SIDE, SO THAT SUFFICIENT REDUCTION COULD NOT BE DONE WITH A CABLE. SUBSEQUENTLY, THE STEM SIZE WAS CHANGED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER SURGERY, THE PATIENT COMPLAINED OF PAIN. THE SURGEON STATED THAT IT MIGHT BE DUE TO CUP LOOSENING. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024. NO FURTHER INFORMATION IS AVAILABLE. THIS PC IS RELATED TO (B)(4) WHICH REPORTS THAT THE CUP LOOSENING OCCURRED AFTER THE PRIMARY SURGERY. THIS PC REPORTS THAT SUFFICIENT FIXATION COULD NOT BE ACHIEVED DURING THE PRIMARY SURGERY.

  Patient problems: Limb Fracture

  MAUDE report 21048202 ↗
• InjuryDec 16, 2022Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO DISLOCATION WITH FAILURE OF CLOSED REDUCTION. LOOSENING OF STEM AT BONE TO IMPLANT INTERFACE WAS REPORTED. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15995684 ↗
• MalfunctionMar 1, 2022Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE BHA FOR FEMORAL NECK BONE FRACTURE WITH THE STEM IN QUESTION. IN THE SURGERY, IT WAS DIFFICULT TO OPEN THE PACKAGE BECAUSE THE SEALING OF THE PACKAGE WAS STRONG, AND THE PAPER ADHERED TO THE CLEAN AREA. THE LABEL REMAINED ON THE IMPLANT WHILE TAKING OUT. THE IMPLANT WAS TAKEN OUT WITH KOCHER FORCEPS, BUT THE SURGEON CONSIDERED IT TO BE UNCLEAN. THEREFORE, THE STEM WAS DISCARDED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13635711 ↗