CORAIL L98013Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295262329), received between Apr 26, 2018 and Oct 30, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Malposition of Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23430295 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE SALES REP ATTENDED A GIRDLE STONE OPERATION DUE TO AN INFECTION. THE DETAILS LEADING UP TO THE GIRDLE STONE OPERATION ARE AS FOLLOWS: (B)(6) 2023, THE PATIENT HAD A SUBTROCHANTERIC FRACTURE OF THE LEFT FEMUR AND UNDERWENT INITIAL SURGERY WITH A NAIL. IT IS UNKNOWN WHETHER THE NAIL WAS A J&J¿S PRODUCT OR NOT. ON (B)(6) 2024, THE PATIENT HAD A SECOND SUBTROCHANTERIC FRACTURE OF THE LEFT FEMUR. THE NAIL BREAKAGE ALSO OCCURRED. AN ARTIFICIAL HEAD REPLACEMENT AND ORIF WITH THE IMPLANTS IN QUESTION WAS PERFORMED. ON (B)(6) 2024, DISLOCATION WAS OBSERVED. 2ND WEEK OF (B)(6) 2025, THERE WAS REDNESS AROUND THE WOUND AND SWELLING, AND EXUDATE WAS CONFIRMED FROM THE WOUND, SUGGESTING INFECTION AROUND THE STEM. ON (B)(6) 2025, CONSIDERING THE PATIENT'S MEDICAL HISTORY AND DECLINE IN ADL, THE GIRDLE STONE OPERATION (WHICH WAS SCHEDULED FOR REMOVAL OF ALL IMPLANTS) WAS PERFORMED. THE STEM WAS PRESERVED BECAUSE IT WAS STUCK. THE GIRDLE STONE OPERATION WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE PATIENT'S MEDICAL HISTORY, AND OTHER DISEASES CURRENTLY BEING TREATED, ETC.: ALCOHOLIC CIRRHOSIS, ANXIETY DISORDER, INSOMNIA, STASIS DERMATITIS, RIGHT CO

  Patient problems: Anxiety; Erythema; Joint Dislocation; Swelling/ Edema; Unspecified Infection

  MAUDE report 22051542 ↗
• InjuryMar 4, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. INTRO-OP FINDINGS CONFIRMED LOOSENING. THE STEM WAS REMOVED AND REVISED. DOI: (B)(6) 2020, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 11412004 ↗
• InjuryJul 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. DOI: UNKNOWN, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10219330 ↗
• InjuryApr 26, 2018Malposition of Device; Malposition of Device

  PATIENT WAS REVISED TO ADDRESS INSTABILITY. ON (B)(6) 2018: STEM HAD TOO MUCH VERSION. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7463913 ↗