CORAIL 3L93710Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10603295168874), received between Nov 7, 2017 and May 27, 2025 — classified as 56 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (14 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 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD REVISION OF RIGHT TOTAL HIP ARTHROPLASTY. CORAIL KLA SIZE 10 STEM, 40MM +5 METAL HEAD, 56X40 MOM LINER. THERE WAS A STEM LOOSENING AT NON-CEMENTED INTERFACE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22089662 ↗
• InjuryMar 13, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAINFUL HIP. X-RAY SHOWED LOOSE STEM AND SUBSIDENCE. REVISION WAS PERFORMED. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21592526 ↗
• InjuryFeb 25, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF ANTERIOR PAIN. THE SURGEON DETERMINED THE STEM WAS UNDERSIZED AND POSSIBLY LOOSE. SURGEON EXPLAINED THE CORAIL STEM, 36MM 8.5 CERAMIC HEAD, AND 36X56 ALTRX LINER. REPLACED EXPLAINED COMPONENTS WITH RECLAIM MONOBLOC AND PINNACLE DUAL MOBILITY. NO DELAY TO SURGERY. NO NEGATIVE COMMENTS OR OUTCOMES STATED FROM THE SURGEON. DOI: (B)(6) 2014. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21458592 ↗
• InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF A CORAIL PINNACLE. AFFECTED SIDE: RIGHT PATIENT NOTES WERE UNAVAILABLE THIS WAS DONE AT BOWEN. THEY SAID IT WAS DONE 2 YEARS AGO. REVISION WAS DUE TO INFECTION. ALL COMPONENTS WERE REMOVED. CUP, LINER, STEM, AND HEAD.

  Patient problems: Unspecified Infection

  MAUDE report 18686560 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECENTLY OPERATED PATIENT HAD A FALL AND REQUIRED REVISION SURGERY FOR A PERIPROSTHETIC FRACTURE. DOI: (B)(6) 2023. DOE: (B)(6) 2023. AFFECTED SIDE: LEFT.

  Patient problems: Fall; Limb Fracture; Pain

  MAUDE report 18309937 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO HIP LUXATION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. LEFT HIP. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? UNKNOWN, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN, IP-(B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, IP-(B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE,, IP-(B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE,, IP-(B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, IP-(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: Joint Laxity

  MAUDE report 18041486 ↗
• InjuryOct 6, 2023Migration; Migration

  PATIENT WAS REVISED AS THE STEM SUBSIDED SO REVISED STEM AND HEAD. LEFT ALL OTHER IMPLANTS. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 17887287 ↗
• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: ON (B)(6) 2018 PATIENT UNDERWENT A RIGHT THA. ON (B)(6) 2023: PATIENT BEGAN EXPERIENCING SQUEAKING (NO PAIN). ON (B)(6) 2023: THE PATIENT UNDERWENT A REVISION FOR SQUEAKING. (B)(4) ON (B)(6) 2023: PATIENT DISLOCATED WHILE GETTING UP FROM A COUCH AND EXPERIENCED PAIN. THE PATIENT UNDERWENT A CLOSED REDUCTION UNDER SEDATION ON (B)(6) 2023. THE PATIENT WAS PLACED IN A LEG BRACE DUE TO CONTINUED INSTABILITY WHICH INDICATED THE NEED FOR ANOTHER REVISION. ON (B)(6) 2023: THE PATIENT UNDERWENT A SECOND REVISION. (B)(4).

  Patient problems: Pain

  MAUDE report 16706868 ↗
• InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT HAD AN INFECTION. THE IMPLANT IN QUESTION WILL BE REMOVED, AND A SPACER MOLD WILL BE INSERTED ON DATE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2019. DOR: UNKNOWN. UNKNOWN SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 15931990 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTED HIP. ALL COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED. THE ACETABULAR CUP WAS LOOSE. LOOSENING INTERFACE WAS NON-CEMENTED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15820615 ↗
• InjuryNov 8, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HIP PAIN. RADIOGRAPHIC SIGNS OF LOOSENING FEMORAL STEM IMPLANT. THE LOOSENING WAS REPORTED FOR NON-CEMENTED INTERFACE. THERE WAS NO REPORTED SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 15752346 ↗
• InjuryJan 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PERIPROSTHETIC HIP FRACTURE. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 13315920 ↗
• InjuryJan 11, 2022Osseointegration Problem; Osseointegration Problem

  REVISION COMPLETED DUE TO PAINFUL RIGHT HIP AND LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2021, DOR: (B)(6) 2021, (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 13232720 ↗
• InjuryDec 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WASHOUT AND DIRECT EXCHANGE OF IMPLANTS DUE TO INFECTION. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? YES. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES. HARDWARE/EXPLANT REMOVAL DUE TO: INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 13118072 ↗
• InjuryNov 9, 2021Adverse 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 INSTABILITY. NOTHING FURTHER TO REPORT. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 12780970 ↗
• InjuryAug 26, 2021Osseointegration Problem; Migration; Osseointegration Problem; Migration

  TOTAL HIP REVISION - CORAIL/PINNACLE CONSTRUCT REMOVED. PRIMARY PROCEDURE CONDUCTED VIA DAA ON 13/07/2018 VIA DAA FOR DIAGNOSIS OF OA. PATIENT REPORTED PAIN/DISCOMFORT 2 YEARS + POST OP. ACCORDING TO HCP, CLINICAL PRESENTATION ON X-RAY OVER TIME CONSISTENT WITH EITHER INFECTION OR SUBSIDENCE/ASEPTIC LOOSENING BUT NO DIAGNOSIS OF EITHER. SEVERAL TESTS CONDUCTED BETWEEN FEB 2021 - AUG 2021, NO CLEAR INDICATION OF INFECTION BUT RESULTS COULD NOT RULE OUT IT OUT AS DIAGNOSIS. SURGEON OPTED FOR 2 STAGE FULL HIP REVISION. ON X-RAY A MORE RADIOPAQUE PORTION WAS IDENTIFIED/QUESTIONED BY HCP IN THE THREATED INSERTER PORTAL OF THE CORAIL STEM. DOI: (B)(6) 2018, DOR: (B)(6) 2021, UNKNOWN SIDE.

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

  MAUDE report 12370509 ↗
• MalfunctionJun 21, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THIS PATIENT HAD A LEFT TOTAL HIP. WHEN THE FOAM TRUNION PROTECTOR WAS TAKEN OFF THE REAL FEMORAL STEM, IT WAS BRITTLE AND CRUMBLED INTO MULTIPLE PIECES. IT SEEMED TO BE DRIED OUT AND ALMOST DUST-LIKE WHEN REMOVED. THE EXPIRATION ON THE STEM WAS WITHIN 2 WEEKS, SO ONE EXPLANATION WAS THAT IT WAS DRIED OUT DUE TO THE LONG SHELF LIFE. IT WAS ALSO INDICATED THAT THERE WAS A SURGICAL DELAY OF TEN (10) SECONDS. NO ADVERSE REACTIONS AS LONG AS ALL THE BRITTLE FOAM PIECES WERE FOUND. NO INSTRUMENTATION BROKE. NO FURTHER INFORMATION IS AVAILABLE. DOE: (B)(6) 2021. AFFECTED SIDE: LEFT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12032827 ↗
• InjuryMay 5, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAINFUL LEFT HIP AND UNDERWENT REVISION FOR A LOOSE FEMORAL STEM WHICH WAS REMOVED. PATIENT'S ACETABULAR POLY LINER WAS REPLACED ALSO DURING REVISION FOR A SIMILAR REPLACEMENT POLY. FEMORAL STEM WAS REVISED WITH A BIOMET STEM. NO FURTHER INFORMATION AVAILABLE. DOI: (B)(6) 2009; DOR: (B)(6) 2021; LEFT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 11780558 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING END OF STEM PAIN, SO SURGEON REMOVED CORAIL STEM AND PUT IN A MODULAR STEM AND PINNACLE DUAL MOBILITY. DOI:(B)(6) 2020: DOR: (B)(6) 2021: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 11691381 ↗
• InjuryMar 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2018 VIA THA. THE CAUSE OF THE REVISION SURGERY IS REPORTED REPETITIVE DISLOCATION THAT CAUSED BY IMPINGEMENT OF IMPLANTS. THE SURGERY WAS PERFORMED ON (B)(6) 2021, THE SURGEON FOUND WELL FIXATION OF IMPLANTS AND SUSPICION OF INFECTION, HE ONLY IRRIGATED AND COMPLETED THE SURGERY. THE CAUSE WAS NOT IMPINGEMENT, IT WAS INFECTION. THE STABILITY OF THE IMPLANT WAS IN GOOD CONDITION IN THIS EVENT.

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

  MAUDE report 11474130 ↗
• InjuryMar 9, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT REPORTED TO DR. (B)(6) THAT SHE WAS EXPERIENCING PAIN IN HER HIP AREA AFTER HAVING A FALL . X-RAY WAS TAKEN AND THE DOCTOR BELIEVED THERE MAY BE SOME LOOSENESS IN FEMORAL PROSTHETIC. DURING SURGERY STEM WAS FOUND TO BE NOT WELL FIXED. DR. EXPLANTED STEM AND REPLACED WITH A WELL FITTING CORAIL REVISION STEM. DOI: (B)(6) 2020. DOR: (B)(6) 2021; LEFT HIP.

  Patient problems: Fall; Inadequate Osseointegration; Pain

  MAUDE report 11446604 ↗
• InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. IT'S NOT BELIEVED THAT THE IMPLANTS CONTRIBUTED TO THE EVENT. THE SURGEON INSERTED A PROSTALAC HIP SPACER. DOI: (B)(6) 2020. DOR: (B)(6) 2020. AFFECTED SIDE: LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10684440 ↗
• InjurySep 30, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT WAS HAVING PAIN AND DISCOMFORT IN HIP JOINT. SO SURGEON WENT IN TO DO A HIP AND LINER EXCHANGE AND NOTICED THAT THE PROXIMAL PORTION OF THE STEM WAS ROTATING. HE PULLED THE STEM AND REPLACED WITH A RECLAIM REVISION STEM AND REPLACE LINER AND PUT NEW FEMORAL HEAD TO HELP WITH STABILITY. IT WAS ALSO REPORTED THAT PATIENT HAD LOOSENING OF THE STEM AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2018, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Discomfort; Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 10606725 ↗
• InjuryJul 14, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT PRESENTED WITH PAIN. DR. (B)(6) UPON REVIEWING FILM FELT STEM MAY POSSIBLY BE LOOSE. SURGERY WAS SCHEDULED AND STEM WAS FOUND TO BE LOOSE AT IMPLANT TO BONE INTERFACE. SZ 10 KLA CORAIL WAS REPLACED WITH A SZ14 CORAIL REVISION STEM. DOI: (B)(6) 2018. DOR: (B)(6) 2020. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 10271124 ↗
• InjuryMar 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION TOTAL HIP REPLACEMENT; REASON FOR REVISION; PAIN AND DISCOMFORT, DIAGNOSED AS A FEMORAL NERVE PALSY PATIENT COMPLAINING OF PAIN AND DISCOMFORT. SYMPTOMS CONSISTENT WITH FEMORAL NERVE PALSY. INVESTIGATIONS (MRI) AND SECOND OPINION CONSULTED. RADIOLOGIST OPINION AND VARIOUS ORTHOPAEDIC OPINION SUGGEST AN ACETABULAR CANCELLOUS BONE SCREW DESPITE BEING ONLY 25MM LONG MAY HAVE PERFORATED THE BONEY PELVIC WALL AND CAUSED IRRITATION OF THE FEMORAL NERVE. THIS WAS PURELY A SUSPICION BASED ON COLLECTIVE OPINION AS A POTENTIAL POSSIBLE CAUSE. THE PATIENT IS VERY SMALL IN STATURE AND HAS DYSPLASIA OF THE HIP. (ACETABULAR COMPONENT ONLY 44MM). THE PATIENT'S HIP WHEN REDUCED RESULTED IN A LEG LENGTHENING OF OVER ONE CM TO CORRECT THE SHORTENING OF THE AFFECTED LEG ASSOCIATED WITH THE DYSPLASIA OF THE HIP. THE POLYETHYLENE LINER WAS REMOVED AND THE SCREW REMOVED WITHOUT INCIDENT. THE LINER WAS THEN REPLACED WITH AN IDENTICAL NEW 28MM NEUTRAL 44MM POLYETHYLENE PINNACLE ACETABULAR LINER. THE CERAMIC FEMORAL HEAD REMAINED INSITU ON THE CORAIL FEMORAL STEM DURING THE LINER REMOVAL, SCREW REMOVAL, AND LINER REPLACEMENT. THE HIP WAS THEN REDUCED AND CLINICAL STABILITY WAS ACHIEVED WITH A RANG

  Patient problems: Discomfort; No Code Available; Pain; Tissue Damage

  MAUDE report 9793669 ↗