CORAIL L971209Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295455394), received between Jun 23, 2020 and Jul 11, 2025 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (3 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.

• InjuryJul 11, 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 PAIN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 22484940 ↗
• InjuryJun 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT THERE WAS A BROKEN ROD. PAIN AND DIFFICULTIES OF MOBILIZATION. THE BROKEN ROD WAS REMOVED AND REPLACED WITH A NEW ONE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 22306694 ↗
• MalfunctionApr 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  THE EVENT DESCRIPTION INDICATED THAT THERE WAS A SURGICAL DELAY OF 5 MINUTES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19152461 ↗
• InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. NO SURGICAL DELAY. DOI: (B)(6) 2020; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12239593 ↗
• InjuryMay 4, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT ON (B)(6) 2015, THE PATIENT UNDERWENT THA. AFTER THE SURGERY, LOOSENING OF THE RIGHT STEM OCCURRED DUE TO LATE INFECTION. AFTER THE INFECTION SUBSIDED, ON (B)(6) 2021, THE REVISION SURGERY WAS PERFORMED. IN THE REVISION, THE STEM AND HEAD WERE REPLACED WITH NEW IMPLANTS (USED STEM WAS MANUFACTURED BY OTHER COMPANY). THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION AVAILABLE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inadequate Osseointegration

  MAUDE report 11773589 ↗
• InjuryMay 4, 2021Osseointegration Problem; Osseointegration Problem

  DR STATED PT DISLOCATED. REMOVED POLY, HEAD AND STEM. REPLACED WITH 1 SIZE LARGER STEM AND PLUS 4 10 DEGREE LINER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11771250 ↗
• InjuryDec 3, 2020Osseointegration Problem; Osseointegration Problem

  REVISION OF A CORAIL PINNACLE STEM DUE TO LOOSENING. CORAIL STEM AND CERAMIC HEAD WERE REMOVED (32+5, LOT NUMBER NOT COMING UP IN THE SEARCH FOR IMPACTED PRODUCTS). RECLAIM STEM WAS IMPLANTED. CUP AND LINER WERE NOT REVISED AS THEY WERE NOT COMPROMISED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN. WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN. WERE FRAGMENTS GENERATED? UNKNOWN. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES. UNKNOWN. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. OTHER INFORMATION. RIGHT HIP. IS THE PATIENT PART OF A CLINICAL STUDY. UNKNOWN. (B)(4). DEVICE PROPERTY OF. NONE. DEVICE IN POSSESSION OF. NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10941090 ↗
• InjuryNov 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. NO SURGICAL DELAY. DOI: (B)(6) 2020; DOR: (B)(6) 2020; AFFECTED SIDE: UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 10889401 ↗
• MalfunctionNov 5, 2020Missing Information; Missing Information

  IT WAS REPORTED THAT THE A SIZE 9 125 DEGREE SIZE 9 STANDARD CORAIL WAS TRIALED AND IMPLANTED. POST-OP WHILE DICTATING THE SURGEON NOTICED THE IMPLANT STICKER SAID SIZE 9 STANDARD CORAIL. NO MENTION OF IT BEING A 125 DEGREE STANDARD CORAIL. THE IMPLANT BOX WAS PULLED FROM THE TRASH TO CONFIRM IT WAS A 125 DEGREE STEM. ALSO PULLED RECORDS FROM A PREVIOUS 125 DEGREE STANDARD CORAIL CASE SHE DID THE WEEK PRIOR TO CONFIRM THAT THE STICKER FROM IT DID INDEED SAY 125 DEGREE. IT DID. THAT IMPLANT WAS A SIZE 14 125 DEGREE STANDARD CORAIL. SHE IS WANTING TO KNOW WHY WE WOULD PUT 125 DEGREE ON SOME SIZES AND NOT OTHERS AS WELL AS THE POTENTIAL TO THINK THERE WAS ANOTHER STYLE OF STEM IMPLANTED. NO SURGICAL DELAY

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10797155 ↗
• MalfunctionJun 23, 2020Missing Information; Missing Information

  IT WAS REPORTED THAT THE IMPLANT STICKER DOES NOT INDICATE THE SHORT NECK PROSTHESIS, NORMALLY WRITTEN AS 125° STANDARD COLLAR. SURGEON REQUESTS INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10184761 ↗