CORAIL L971111Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295455301), received between Dec 7, 2018 and Dec 4, 2023 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Osseointegration Problem” (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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL STEM. DOI: (B)(6), 2019. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18258686 ↗
• InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC FX .

  Patient problems: Limb Fracture

  MAUDE report 17720674 ↗
• InjuryDec 22, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE DR HAD TO TAKE THE ORIGINAL STEM OUT AND REVISE. REVISION WAS EITHER TO INFECTION OR POST IMPLANT PT FALL. DOI: (B)(6) 2022. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Fall; Inadequate Osseointegration; Unspecified Infection

  MAUDE report 16033403 ↗
• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION OF THE JOINT AND HIP WAS EXPLANTED. A PROSTALAC WAS PLACED FOR TEMPORARY INFECTION ERADICATION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2012. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15086183 ↗
• InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INSTABILITY OF THE HIP JOINT AND RECURRING DISLOCATIONS. CUP AND STEM WERE REVISED. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 13903789 ↗
• InjuryJun 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN. DOI: UNKNOWN DOR: (B)(6) 2021 RIGHT HIP.

  Patient problems: Pain

  MAUDE report 11934862 ↗
• InjuryApr 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL, REVISED DUE TO FRACTURE. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2021; LEFT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 11712899 ↗
• InjuryJul 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL IN HOSPITAL ROOM, PERIPROSTHETIC FX.. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT SIDE.

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

  MAUDE report 10264921 ↗
• InjuryJun 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH PAIN FOLLOWING PRIMARY CORAIL / PINNACLE HIP DONE IN 2017 REVISION DONE ON (B)(6) 2019. LINER EXCHANGE AND ETO TO REMOVE STEM. STRYKER RESTORATION MODULAR IMPLANTED. SURGEON THINKS POSSIBLE OSTEOLYSIS.

  Patient problems: No Code Available; Osteolysis; Pain

  MAUDE report 8670200 ↗
• MalfunctionDec 7, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  DISCREPANCY BETWEEN THE SIZE OF THE TRIALS AND REVISED DUE TO SEPSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8143791 ↗