CORAIL L971210Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295455400), received between Oct 29, 2020 and Apr 6, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON JANUARY 19, 2026, THE PATIENT UNDERWENT THA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. ON (B)(6) 2026, THE PATIENT SUFFERED HIP DISLOCATION. THE DISLOCATION WAS SUCCESSFULLY REDUCED MANUALLY. SINCE THERE WERE NO PROBLEMS WITH THE PLACEMENT OF THE IMPLANTS, THE SURGEON DECIDED TO MONITOR THE SITUATION FOR A WHILE. ACCORDING TO THE SURGEON, THE PATIENT FELL SHORTLY AFTER THE THA SURGERY AND SUFFERED GREATER TROCHANTERIC FRACTURES. THE FRACTURES WERE TREATED WITH CABLES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Fall; Joint Laxity; Limb Fracture

  MAUDE report 24793918 ↗
• InjuryApr 2, 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 INFECTED HIP AND EXPLANT THEN STAGE 1 OF A 2 STAGE REVISION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 21755711 ↗
• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO HIP INFECTION. STAGE 1 OF 2 WAS PERFORMED AND SURGEON EXPLANTED ALL OF THE EXISTING IMPLANTS. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21753310 ↗
• MalfunctionSep 24, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT WHEN WENT TO PASS STEM, CIRCULATOR NOTICED A PUNCTURE HOLE IN TOP OF STERILE PACKAGING. DID NOT OCCUR WHILE OPENING PACKAGE OR HAND OFF TO CIRCULATOR. NO SIGNS OF PUNCTURE ON CARDBOARD BOX, CARDBOARD INSERT, OR CELLOPHANE WRAP. STEM NEVER WAS PASSED AS WE NOTICED PRIOR TO PASSING IT. SURGICAL DELAY OF 12 MINUTES OCCURRED. DOI: UNKNOWN, DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15481485 ↗
• InjuryApr 14, 2021Migration; Migration

  ON (B)(6) 2021 FIRST INTENTION PTH, ON (B)(6) 2021 REVISION PTH, IMPLANTATION OF THE FEMORAL STEM PERFORMED ON (B)(6) WHICH REQUIRED A SURGICAL REVISION WITH A CHANGE OF STEM AND HEAD ON (B)(6) WITH A CEMENTED STEM. ON (B)(6) THERE WAS A PROBLEM WHEN REMOVING THE IMPACTOR, WHICH REMAINED ATTACHED TO THE STEM. THIS REDUCED THE STRENGTH OF THE FINAL STEM AND CAUSED IT TO SINK IN. THEN IT WAS NECESSARY TO EXPLANT IT DURING A SECOND SURGERY. DOI: (B)(6) 2021. DOR: (B)(6) 2021; AFFECTED SIDE: UNKNOWN.

  Patient problems: Limb Fracture

  MAUDE report 11664078 ↗
• InjuryOct 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020 VIA THA. IT WAS REPORTED THAT AFTER THE SURGERY, THE PATIENT VISITED THE HOSPITAL DUE TO UNCOMFORTABLE FEELING OF HIP JOINT. THE SURGEON FOUND SMALL TROCHANTERIC FRACTURE BY X-RAY. ON (B)(6) 2020, THE SURGEON PERFORMED A SURGERY FOR FRACTURE REDUCTION WITH AN UNKNOWN CABLE. THE SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Discomfort; No Code Available

  MAUDE report 10755409 ↗