CORAIL L971112Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295455318), received between Aug 21, 2019 and Aug 28, 2025 — classified as 15 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (6 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THERE WAS PERSISTENT COMPLICATIONS FOLLOWING HIP PROSTHESIS SURGERIES. PATIENT UNDERWENT INITIAL HIP REPLACEMENT IN 2019, WHICH CONSISTENTLY CAUSED ISSUES. FROM THE MOMENT OF THE OPERATION, THE PATIENT COMPLAINED OF A MEASUREMENT ISSUE; HIS OPERATED LEG WAS 2 CM LONGER. AFTER 4 YEARS OF PAIN AND MULTIPLE VISITS TO THE SURGEON, THE PATIENT DECIDED TO CONSULT ANOTHER SURGEON. AFTER SEVERAL EXAMINATIONS, A REVISION WAS DECIDED. IN (B)(6) 2023, THE LOOSENED PROSTHESIS WAS REMOVED AND A SPACER WAS PLACED DUE TO SUSPECTED INFECTION. A NEW PROSTHESIS WAS IMPLANTED IN (B)(6) 2023, BUT PAIN AND FLUID BUILDUP PERSIST. MULTIPLE TESTS (PUNCTURES, CLEAN-UP SURGERY, ARTHROSCOPY) HAVE RETURNED NEGATIVE RESULTS. REFERRED TO THE HOSPITAL, WHERE ALLERGY IS NOW BEING CONSIDERED.

  Patient problems: Hypersensitivity/Allergic reaction; Inadequate Osseointegration; Pain; Physical Asymmetry; Swelling/ Edema; Unspecified Infection

  MAUDE report 22910981 ↗
• InjuryJun 16, 2025Osseointegration Problem; Osseointegration Problem

  THE PATIENT PRESENTED WITH PAIN. THE STEM WAS REMOVED WHICH APPEARS TO BE LOOSE AT THE STEM/BONE INTERFACE. THEN CONVERTED TO A DUAL MOBILITY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 22213886 ↗
• InjuryMay 2, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE THA WAS INFECTED. I&D OCCURRED ON (B)(6) 2024 BUT FAILED. THE FEMUR WAS LOOSE. DURING THE HIP EXPLANT PROCEDURE ON (B)(6) 2025, THE WATSON FEMORAL SLAP HAMMER WAS BENT TRYING TO REMOVE THE STEM. THIS REPORT CAPTURES THE REVISION PROCEDURE. RELATED COMPLAINT (B)(4), CAPTURED THE I&D FAILURE. RELATED COMPLAINT(B)(4), CAPTURES THE INFECTION. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 21950031 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE THA WAS INFECTED. I&D OCCURRED ON (B)(6) 2024 BUT FAILED. THE FEMUR WAS LOOSE. DURING THE HIP EXPLANT PROCEDURE ON (B)(6) 2025, THE WATSON FEMORAL SLAP HAMMER WAS BENT TRYING TO REMOVE THE STEM. THIS REPORT CAPTURES THE INFECTION. RELATED COMPLAINT (B)(4) CAPTURED THE I&D FAILURE. RELATED COMPLAINT (B)(4) CAPTURES THE REVISION PROCEDURE. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 21949923 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SAFETY DATA SHEETS WERE NEEDED ON THESE THREE PRODUCTS DUE TO AN INVESTIGATION CONCERNING ALLERGIC REACTIONS. THE PATIENT IS GOING TO HAVE A SECOND SURGERY IN THE BEGINNING OF JANUARY.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21137113 ↗
• InjuryNov 1, 2024Adverse 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 INFECTION. DOI: (B)(6) 2020. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20588604 ↗
• InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT DETAILS: START DATE: ON (B)(6) 2022. EVENT DAY: 0. ALERT DATE: ON (B)(6) 2022. ALERT TIME: 04:15 PM. COUNTRY OF EVENT: CAN. ADVERSE EVENT TERM: POSSIBLE CALCAR SPLIT. PATIENT DETAILS: PATIENT IDENTIFIER: (B)(6). SEX: FEMALE. AGE (AT TIME OF CONSENT): 59 YEARS. ADDITIONAL EVENT DETAILS: SEVERITY : MODERATE. IS THE ADVERSE EVENT SERIOUS? NO. DEATH: NO. A LIFE-THREATENING ILLNESS OR INJURY: NO A PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR A BODY FUNCTION: NO REQUIRED IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION: NO ADMISSION DATE: BLANK DISCHARGE DATE: BLANK RESULTED IN MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION: NO LED TO A FETAL DISTRESS, FETAL DEATH OR A CONGENITAL ABNORMALITY OR BIRTH DEFECT: NO RELATIONSHIP TO STUDY DEVICE : NOT RELATED IF THE EVENT IS SERIOUS AND DEVICE OR PROCEDURE RELATED, ACCORDING TO THE DEFINITION DOCUMENTED IN THE PROTOCOL AND INSTRUCTIONS FOR USE, IN THE OPINION OF THE INVESTIGATOR, IS THE ADVERSE EVENT EXPECTED/ANTICIPATED?: N/A (IF DOES NOT MEET ABOVE CRITERIA) RELATIONSHIP TO PRIMARY STUDY PROCEDURE : NOT RELATED RELATIONSH

  Patient problems: Limb Fracture

  MAUDE report 16104214 ↗
• InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  QUERY INFECTION AND SURGEON DECIDED TO TAKE THE IMPLANTS OUT THAT WHERE IN SITU IN 2018. DOI: (B)(6) 2018. DOR: (B)(6) 2022. UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15959860 ↗
• InjuryJun 14, 2022Osseointegration Problem; Osseointegration Problem

  REASON FOR IMPLANT INSERTION: DUAL MOBILITY LINER INSERTED TO PREVENT RISK OF DISLOCATION

  Patient problems: Inadequate Osseointegration

  MAUDE report 14685469 ↗
• InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. I&D INSERTION OF PROSTALAC. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13930065 ↗
• InjuryFeb 16, 2022Osseointegration Problem; Osseointegration Problem

  PROXIMAL LEFT FEMORAL VALGUS OSTEOTOMY WITH INTERNAL DEROTATION AND TOTAL HIP ARTHROPLASTY. IMPLANT WITH NO INTEGRATION AT TWO MONTH POST-OP ; COLLAPSE OF THE INITIAL ASSEMBLY AND LEFT PROXIMAL FÉMUR FRACTURE. DOI: (B)(6) 2021; DOR: (B)(6) 2022; LEFT KNEE.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Pain

  MAUDE report 13542444 ↗
• MalfunctionJan 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANT WAS USED TODAY, AS I MENTIONED EARLIER THIS IS NOT THE FIRST TIME WE HAD THIS PROBLEM IT HAPPENED ON 29TH OCT WHICH HAPPENED TO BE THE SAME SIZE BUT ON A STD 12 RATHER THAN HIGH OFFSET 12.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266608 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S HIP IS INFECTED SO THE SURGEON REMOVED ALL COMPONENTS AND PUT IN ANTIBIOTIC HIP SPACER. DOI: (B)(6) 2020. DOR: (B)(6) 2021. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 12925917 ↗
• InjuryOct 6, 2021Osseointegration Problem; Osseointegration Problem

  AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12583557 ↗
• InjuryNov 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Bone Fracture(s)

  MAUDE report 10919754 ↗
• InjuryOct 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INTRAOPERATIVE CALCAR FEMUR FRACTURE. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2020, DATE OF EVENT: (B)(6) 2020, (RIGHT HIP). TREATMENT: ORIF.

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

  MAUDE report 10656601 ↗
• MalfunctionJan 9, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE CORAIL HIGH OFFSET STEM SIZE 12 WAS USED DURING IMPLANTATION AND THE STEM DIDN'T FIT LIKE THE RASP. THE STEM FIXED 7-8MM OVER THE RESECTION LINE. THE RASP WAS EXACTLY AT THE RESECTION LINE. A MISSUSE OR A ROTATIONAL ERROR WASN'T OBVIOUS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9570794 ↗
• MalfunctionAug 21, 2019Contamination /Decontamination Problem; Packaging Problem; Contamination /Decontamination Problem; Packaging Problem

  IT WAS REPORTED THAT UPON OPENING THE IMPLANT, IT WAS NOTICED THAT THERE WAS A PUNCTURE IN THE STERILE PACKAGING. THERE WAS NO HOLE OR PUNCTURE IN THE OUTER PACKAGING. ANOTHER IMPLANT WAS RETRIEVED WITHIN 10 MINUTES. DOE: (B)(6) 2019, UNKNOWN AFFECTED SIDE.

  Patient problems: Not Applicable

  MAUDE report 8915173 ↗