CORAIL 3L92501Recalls & reported problems

Summary

The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 10603295168676), received between Apr 30, 2015 and Feb 5, 2026 — classified as 102 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (18 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 25 most recent of 108 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INSTABILITY AND FRACTURE. NO ADDITIONAL INFO. DOI- (B)(6) 2021, DOR- (B)(6) 2026, AFFECTED SIDE- LEFT HIP.

  Patient problems: Joint Laxity; Limb Fracture

  MAUDE report 24266687 ↗
• InjuryDec 18, 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: (B)(6) 2020. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 23845293 ↗
• InjurySep 16, 2025Migration; Migration

  IT WAS REPORTED THAT PATIENT PRESENTED WITH PAIN AND FEELING UNSTABLE. UPON X-RAY THE DOCTOR FOUND POSSIBLE CALCAR FRACTURE AND STEM SUBSIDED. SURGERY WAS SCHEDULED. STEM WAS REMOVED AND REPLACED. CUP WAS WELL FIXED. REPLACED NEUTRAL LINER WITH A 10 DEGREE LINER AND CHANGED HEAD BALL. SURGERY WAS SUCCESSFUL. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity; Limb Fracture; Pain

  MAUDE report 23061715 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH PAIN AND FEELING UNSTABLE. UPON X-RAY THE DOCTOR FOUND POSSIBLE CALCAR FRACTURE AND STEM SUBSIDED. SURGERY WAS SCHEDULED. STEM WAS REMOVED AND REPLACED. CUP WAS WELL FIXED. REPLACED NEUTRAL LINER WITH A 10 DEGREE LINER AND CHANGED HEAD BALL. SURGERY WAS SUCCESSFUL. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23061634 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT HAD AN ONGOING GROIN PAIN AND DISCOMFORT FOLLOWING BOTH PRIMARY PROCEDURE AND FIRST REVISION.

  Patient problems: Discomfort; Pain; Unspecified Tissue Injury

  MAUDE report 22912173 ↗
• InjuryAug 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT THERE WAS A REVISION TOTAL HIP REPLACEMENT. THE CORAIL STEM HAS FRACTURED AT THE NECK REGION. STEM ORIGINALLY IMPLANTED ON (B)(6) 2017. ACCORDING TO THE SURGEON THE PATIENT DID NOT HAVE A FALL, WAS SIMPLY STRETCHING TO PUT HIS PANTS ON AND FELT IT GIVE WAY. SURGEON ALSO STATED THAT THE PATIENTS POSTERIOR HIP CAPSULE WAS DEFICIENT. THE PATIENT HAD PREVIOUSLY COMPLAINED OF GROIN PAIN AND HAD SEEN 2 OTHER SURGEONS IN RELATION TO THIS FOR HIP ARTHROSCOPY¿S WHERE THEY PERFORMED PSOAS TENDON RELEASES. STEM WAS VERY WELL FIXED AND TOOK CONSIDERABLE EFFORT TO REMOVE FROM THE FEMORAL CANAL. PATIENTS ORIGINAL SURGERY WAS FOR A HEMIARTHROPLASTY BIPOLAR FOR A FRACTURED NECK OF FEMUR. THIS WAS LATER REVISED TO A TOTAL HIP WITH THE FEMORAL STEM LEFT INSITU AND THE ACETABULAR CONVERTED FROM A BIPOLAR TO A PINNACLE THR.

  Patient problems: Pain

  MAUDE report 22814011 ↗
• InjuryJun 27, 2025Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL COMPONENT AT NON CEMENTED INTERFACE. UNKNOWN CEMENT WAS USED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2016, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22346275 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT IS REPORTING THAT POST SURGERY ONE LEG IS NOW LONGER THAN THE OTHER.

  Patient problems: Pain; Physical Asymmetry

  MAUDE report 21912891 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION FOR LEG LENGTH. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Physical Asymmetry

  MAUDE report 21775576 ↗
• MalfunctionJan 2, 2025Missing Information; Missing Information

  IT WAS REPORTED THAT 01 UNIT OF THE PRODUCT WAS RECEIVED WITHOUT THE TRACEABILITY LABEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21060444 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SALES REP WAS INFORMED OF AN EVENT INVOLVING A POSSIBLE INFECTION WHILE DEPUY SYNTHES IMPLANTS WERE PLACED. IT IS UNKNOWN AT THIS TIME WHAT INTERVENTIONS HAVE TAKEN PLACE.

  Patient problems: Unspecified Infection

  MAUDE report 20290165 ↗
• InjuryJun 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT INVOLVED IN MVA. SUFFERED PERIPROSTHETIC FRACTURE AT IMPLANT SITE. PATIENT WAS OPERATED ON AT HOSPITAL. PATIENT WAS STILL IN PAIN POST OP AND CAME BACK TO SURGEON FOR CONSULTING. SURGEON SUSPECTED FRACTURE OF HEAD BALL IMPLANT AND BOOKED PATIENT FOR SURGERY. UPON SURGERY IT WAS DISCOVERED THAT THE HEAD BALL HAD FRACTURED INTO MULTIPLE PIECES. ALL PIECES WERE REMOVED FROM PATIENT AND HEAD BALL WAS REPLACED WITH NEW IMPLANT. DOI: ON (B)(6) 2020, DOR: ON (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture; Pain

  MAUDE report 19497973 ↗
• InjuryFeb 28, 2024Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO PAIN. LOOSENING OF STEM AT BONE TO IMPLANT INTERFACE WAS ALSO INDICATED. DOI- (B)(6) 2019 DOR- (B)(6) 2024 AFFECTED SIDE- RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 18798560 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 18443641 ↗
• InjuryJan 2, 2024Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO METAL ON METAL WEAR. THERE WAS ALSO LOOSENING PRESENT WITH INTERFACE NON-CEMENTED. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2004. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18425964 ↗
• InjuryMar 10, 2023Fracture; Fracture

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT EXPERIENCED MODERATE PAIN WITH ACTIVITY RESTRICTIONS. THERE WAS PAIN IN THE BUTTOCKS RADIATING TO THE CALF, PAIN AFTER A FEW STEPS AND AT NIGHT. THE PATIENT HAD SLIGHT LIMP WHEN WALKING. THERE WAS INEQUALITY OF LENGTH, SIDE TO OPERATE SHORTER.

  Patient problems: Ambulation or Postural Difficulties; Fall; Limb Fracture; Loss of Range of Motion; Pain; Physical Asymmetry

  MAUDE report 16522714 ↗
• InjuryFeb 8, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT ACCORDING TO THE SURGEON THE PATIENT HAD A STRING OF A STAPH INFECTION. THERE WAS A LOOSENING OF STEM AT BONE TO IMPLANT INTERFACE. SURGEON IMPLANTED A PROSTALC IMPLANT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2018. DOR: (B)(6) 2023. AFFECTED SITE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 16325879 ↗
• InjuryJan 4, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND IMPLANT WAS LOOSENED DUE TO A PERI PROSTHETIC HIP FRACTURE. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 16098497 ↗
• InjuryDec 15, 2022Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE CORAIL STEM. LOOSENING INTERFACE WAS NON-CEMENTED. SURGEON REMOVED STEM AND REPLACED WITH A RECLAIM STEM. SURGEON REPLACED PINNACLE LINER WHILE HE WAS IN THE HIP JOINT TOO. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2014. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15987116 ↗
• MalfunctionNov 29, 2022Inaccurate Information; Wrong Label; Inaccurate Information; Wrong Label

  IT WAS REPORTED THAT THE CORAIL STEM BOX COLOR CODED INCORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15877133 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISED IMPLANTS DUE TO THE PATIENT BEING IN PAIN. OPERATION WAS BELIEVED TO BE DONE AROUND 4 YEARS AGO. SEVERE METALLOSIS WAS SEEN IN THE CAVITY.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 15501595 ↗
• InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. THERE WAS NO LOOSENING REPORTED. NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 15348180 ↗
• InjuryAug 4, 2022Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT (STEM) AT THE BONE TO IMPLANT INTERFACE. PATIENT HEARD POP IN SHOWER AND SUFFERED FRACTURED PROXIMAL FEMUR. PATIENT REVISED TO LONG STEM CORAIL AND FRACTURE REDUCED WITH CABLE. IT WAS ALSO INDICATED THAT THE PATIENT. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 15163094 ↗
• InjuryJul 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AS "ONE SUMMER EVENING NOT TOO LONG AGO THIS PATIENT GOT INTO A DISAGREEMENT WITH HER DAUGHTER OVER SOME BEVERAGES. DISAGREEMENT QUICKLY TURNED PHYSICAL RESULTING IN THIS PATIENT FALLING DOWN. AS A RESULT, SHE WAS CHAUFFEUR VIA AMBULANCE TO LVH MUHL WHERE A MEDICAL PROFESSIONAL DETERMINED THAT SUCH ALTERCATION RESULTED IN HER FRACTURING HER FEMUR. THIS EVENT CAUSED THE PREVIOUS IMPLANTS TO BECOME COMPROMISED AND SURGEON (B)(6) SERVICES WERE CALLED INTO ACTION. ANOTHER SURGEON MADE THE DECISION TO EXPLANT THE FEMORAL STEM, HEAD AND LINER AND REVISE TO A REVISION TYPE STEM WITH A DUAL MOBILITY CONSTRUCT. ANY FURTHER INFORMATION WAS RULED AS HEAR SAY AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME. THERE WAS NO LOOSENING AND NO SURGICAL DELAY." DOI: (B)(6) 2019. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 14977600 ↗
• InjuryJul 1, 2022Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO INFECTION AND LOOSENING OF THE STEM (NON CEMENTED) OF LEFT TOTAL HIP. NO SURGICAL DELAYED DUE TO THIS EVENT. DOI: UNK. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 14884989 ↗