CORAIL L971313Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295478706), received between Jun 23, 2022 and Aug 16, 2023 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SIGNIFICANTLY SHORT NECK STEM IN POST OP. IT IS UNKNOWN WHY THERE WAS SUCH A LEG LENGTH DISCREPANCY FOLLOWING THE FIRST PROCEDURE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Physical Asymmetry

  MAUDE report 17557490 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. IT WAS UNKNOWN IF ANY LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 15322411 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS THAT THE STEM CUT THROUGH THE BONE AND THE DISTAL BONE WAS CRACKED AFTER INSERTION OF IMPLANTS DURING THE PRIMARY SURGERY. THIS PC REPORTS THAT PERI-STEM FRACTURE OCCURRED AFTER THE PRIMARY SURGERY. ON (B)(6) 2022, IT WAS CONFIRMED THAT PERI-STEM FRACTURE OCCURRED AGAIN DURING A VISIT WITH A PHYSICIAN. ACCORDING TO THE PHYSICIAN, THIS FRACTURE IS CLEARLY IN A DIFFERENT LOCATION THAN THE PREVIOUS FRACTURE, THERE IS LIKELY MORE BONE FRAGILITY THAN THE PHYSICIAN EXPECTED. ON (B)(6) 2022, A REVISION SURGERY WILL BE PERFORMED WITH A LONG STEM (THE OTHER COMPANY¿S IMPLANT), A PLATE, AND CABLES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Limb Fracture; Unspecified Tissue Injury

  MAUDE report 15163141 ↗
• InjuryJun 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE BIPOLAR HIP ARTHROPLASTY WITH THE STEM FOR THE FRACTURE OF THE FEMORAL NECK. WHEN THE SURGEON CHECKED THE X-RAYS AFTER INSERTION OF ALL THE IMPLANTS, IT WAS CONFIRMED THAT THE STEM CUT THROUGH THE BONE AND THE DISTAL BONE WAS CRACKED. THEREFORE, THE SURGEON DECIDED TO PERFORM THE OSTEOSYNTHESIS WITH ANESTHETIZED CONDITION. THE FRACTURE SITE WAS STABLE WITH THE INSERTION OF THE STEM, SO THAT THE SURGEON ONCE PULLED THE STEM PROXIMAL TO THE DIAPHYSIS. IT WAS LEFT IN THAT STATE FOR TREATMENT OF THE OSTEOSYNTHESIS. THE OSTEOSYNTHESIS WAS PERFORMED WITH THREE NESPLON CABLES (THE OTHER COMPANY¿S PRODUCT) WHICH WERE PREPARED FOR ANOTHER OPERATION AND THREE CABLES (THE OTHER COMPANY¿S PRODUCTS). WHEN THE SURGEON REMOVED THE HEAD WITH THE HAMMER, THE STEM AND THE TAPERLOC OF THE HEAD WERE DISENGAGED DUE TO VIBRATION. THE SURGEON INSERTED THE STEM AND THE HEAD WITH THE HAMMER AGAIN AND CONFIRMED THAT THE DEVICES WERE NOT DISENGAGED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 100 MINUTES DELAY. ACCORDING TO THE SURGEON, THE SURGEON MIGHT HAVE APPLIED TOO MUCH FORCE EXTERNALLY WHILE INSERTING THE IMPLANTS, AND DIRECTION OF THE IMP

  Patient problems: Limb Fracture; Unspecified Tissue Injury

  MAUDE report 14787265 ↗