CORAIL L971208Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295455387), received between Mar 17, 2020 and Nov 4, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT ALL IMPLANTS APPEARED TO BE LOOSE. NO PATIENT COMPLICATIONS. AFFECTED SIDE- LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23468059 ↗
• MalfunctionJul 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 19722332 ↗
• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON HAD AN INTRA OP PERIPROSTHETIC FRACTURE ON (B)(6) 2023. DURING AN ANTERIOR HIP, AFTER FINAL IMPACTION OF THE REAL IMPLANT, A LATERAL FRACTURE WAS VISIBLE ON THE INTRA OP XRAY. IT IS UNCLEAR THE PRECISE MOMENT THE FRACTURE OCCURRED. SURGEON WAS USING THE MATTA BROACH HANDLE AND A SIZE 8 CORAIL STEM. DIFFICULT EXPOSURE, PARTICULARLY HARD BONE, A TIGHT DISTAL CANAL, AN OBESE PATIENT WERE ALL FACTORS THAT LIKELY CONTRIBUTED TO THE INCIDENT, BUT ON SUNDAY SURGEON MESSAGED THAT SURGEON WAS CONCERNED THE ANGLE OF IMPACTION OF THE MATTA BROACH HANDLES MAY HAVE ALSO BEEN A CONTRIBUTING FACTOR. SURGEON ALSO REQUESTED TO KNOW IF THERE HAS BEEN ANY OTHER REPORTED INCIDENTS OF FRACTURES USING THESE BROACH HANDLES. SURGERY WAS DELAYED 15 MINUTES. TWO CABLES WERE PLACED TO ADDRESS THE FRACTURE.

  Patient problems: Limb Fracture

  MAUDE report 17939112 ↗
• InjuryNov 8, 2021Fracture; Fracture

  CUSTOMER IS REPORTING A DISTAL FRACTURE OF CORAIL HIP-STEM. DOI: (B)(6) 2019, DOR: UNKNOWN, UNKNOWN SIDE.

  Patient problems: Insufficient Information

  MAUDE report 12771811 ↗
• InjuryAug 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2021 - DOR: (B)(6) 2021 (LEFT HIP).

  Patient problems: Pain

  MAUDE report 12294885 ↗
• InjuryOct 13, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED DUE TO PAIN SECONDARY TO PERIPROSTHETIC FRACTURE. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: UNKNOWN, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 10673564 ↗
• InjuryMar 17, 2020Loss of Osseointegration; Loss of Osseointegration

  FEMORAL COMPONENT LOOSENING THOUGHT TO HAVE CRACKED CALCAR DURING PRIMARY SURGERY. CORAIL STEM STILL HAD HA ON PROXIMAL AREA OF STEM WHEN EX PLANTED. DISTAL STEM HA APPEARED TO BE RESORTED.

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

  MAUDE report 9845795 ↗