CORAIL 3L92511Recalls & reported problems

Summary

The FDA's MAUDE database contains 158 adverse event reports that list this exact device (DI 10603295168775), received between May 23, 2014 and May 28, 2026 — classified as 151 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (23 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 158 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR FRACTURE. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 25318940 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A RIGHT CORAIL PINNACLE SECTOR ULTAMET RIGHT WAS IMPLANTED IN 2010. IT WAS REPORTED PATIENT HAD METALOSIS. PATIENT WAS REVISED. ONLY THE ULTAMET INSERT AND HEAD WERE REMOVED.

  Patient problems: Foreign Body Reaction

  MAUDE report 24895349 ↗
• MalfunctionDec 3, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT INTRAOPERATIVELY THE FEMUR WAS PREPARED WITH A SIZE 11 RASP. WHEN IMPLANT WAS INSERTED IT WAS TOO SMALL. A SIZE 12 WAS NEEDED TO BE IMPLANTED. THERE WAS A SURGICAL DELAY OF ABOUT FIVE MINUTES. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706288 ↗
• MalfunctionJun 13, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BROACH HANDLE WAS ATTACHED TO THE CORAIL BROACH AND WOULD NOT DISENGAGE. AFTER IF WAS TAKEN APART IT WAS NOT CLEAR IF THE CORAIL BROACH WAS WORN DOWN OR IF THE BROACH HANDLE DID IT. DOE: MAY 21, 2025 AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22207913 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PERI PROSTHETIC FRACTURE REQUIRING THE PREVIOUS STEM TO BE REPLACED WITH A DISTAL FIXATION STEM. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 22008847 ↗
• InjuryMay 5, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND SUSTAINED A LEFT HIP PERIPROSTHETIC FRACTURE CAUSING STEM TO LOOSEN. DOI: (B)(6) 2022. DOR: (B)(6) 2025; AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 21962784 ↗
• InjuryMar 3, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD RESECTION ARTHROPLASTY PERFORMED AND SEPTIC LOOSENING. THERE WAS STEM AND CUP LOOSENING IN NON-CEMENTED INTERFACE. SURGICAL DELAY WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2018, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Sepsis

  MAUDE report 21510500 ↗
• InjuryJan 14, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TOTAL HIP REPLACEMENT ON (B)(6) 2024. ON (B)(6) 2024, THE SECONDARY SURGERY WAS PERFORMED TO PATIENT DUE TO POST OP PAIN. THE PATIENT IS CURRENTLY STABLE. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT SIDE.

  Patient problems: Pain

  MAUDE report 21150422 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTED AND INFLAMED RIGHT HIP REPLACEMENT. THE PATIENT HAD PAIN ON WEIGHT BEARING. ALL COMPONENTS WERE REMOVED AND CEMENT SPACER WAS IMPLANTED.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 21125584 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT HAD PREVIOUS HIP SURGERY THAT RESULTED IN EXTRA LEG WORK LENGTH AND FEMORAL OFFSET. PATIENT WAS REVISED TO ADDRESS ISSUES. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Physical Asymmetry

  MAUDE report 20398124 ↗
• InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PARTIAL REVISION SURGERY OF YEAR 2023: INSERT DISLOCATION/MOBILIZATION. HEAD AND INSERT REPLACED. DOI: ON (B)(6) 2016. DOE: ON (B)(6) 2023.

  Patient problems: Loss of Range of Motion

  MAUDE report 19791282 ↗
• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT STATED THAT THERE WAS HEAD WITH PINN SECTOR CORAIL FEMORAL WITH GRIPTION 52MM. PATIENT FELT THE UNCEMENTED CORAIL FEMORAL HIP REPLACEMENT WAS RECALLED. THE PATIENT WANTED A CALLBACK. ADDITIONAL EVENT DESCRIPTION: THE PATIENT HAD A RIGHT HIP IMPLANTED ON (B)(6) 2018. SINCE THAT TIME THE PATIENT HAS BEEN EXPERIENCING PAIN AND SWELLING. THE PATIENT HAS HAD MULTIPLE PAIN INJECTIONS AND HAS DONE PHYSICAL THERAPY AND IS LOOKING AT GETTING A REVISION IN THE NEAR FUTURE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 19577160 ↗
• InjuryMay 24, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION DUE TO METALLOSIS AND PSEUODOTUMOR.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction

  MAUDE report 19391302 ↗
• InjuryApr 26, 2024Osseointegration Problem; Osseointegration Problem

  EARLY LOOSENING OF THE CORAIL STEM.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19191225 ↗
• InjuryApr 9, 2024Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED: A. CAN YOU PLEASE PROVIDE THE AFFECTED SIDE? RIGHT SIDE. B. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO DELAY TO SURGERY. C. WAS THERE ANY ALLEGATION AGAINST THE HEAD AND THE LINER? NO ALLEGATION PRESENT. D. WHAT WAS THE LOOSENING INTERFACE? UNCEMENTED IMPLANT THEREFORE IMPLANT AND BONE. E. WAS DEPUY CEMENT USED? IF YES, PLEASE PROVIDE THE PRODUCT DETAILS. NO CEMENT USED.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 19071274 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A HIP REVISION DUE TO DISLOCATING HIP POST THA WAS DEVICE EXPLANTED? --> TRUE, HARDWARE/EXPLANT REMOVAL DUE TO: --> INSTABILITY OF JOINT (DISLOCATION) , DID PATIENT REQUIRE REVISION SURGERY? --> TRUE, DOI: (B)(6) 2023 DOE: (B)(6) 2024 AFFECTED SIDE:

  Patient problems: Joint Laxity

  MAUDE report 18658182 ↗
• InjuryFeb 5, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT SURGEON EXPLANTED HEAD, LINER AND CORAIL STEM ON (B)(6) 2024. CORAIL STEM WAS LOOSE AT BONE TO IMPLANT INTERFACE. DOI: UNKNOWN DOI: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18640591 ↗
• InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT LEFT ASR XL REVISION DUE TO PAIN. DOI: (B)(6) 2009. DOR: DEC 18, 2023. LEFT HIP.

  Patient problems: Pain

  MAUDE report 18518733 ↗
• InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WILL BE REVISED BECAUSE OF METALLOSIS OCCURRED IN CERAMIC ON METAL ARTICULATION. THE REVISION WILL BE PERFORMED ON (B)(6) 2023. NO ADDITIONAL INFO. IF OTHER, DESCRIBE: THA. DID THE EVENT OCCUR DURING STERILE PROCESSING?UNKNOWN. DID THE EVENT OCCUR DURING FIELD INSPECTION? UNKNOWN. DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? SIGNS OF METALLOSIS. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (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

  Patient problems: Foreign Body Reaction

  MAUDE report 18284511 ↗
• InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM DEPUY SYNTHES AUSTRALIA REPORTS AN EVENT AS FOLLOWS: PATIENT HAD A FALL WHICH RESULTED IN A LEFT PERIPROSTHETIC FRACTURE. PATIENT REQUIRED A LINER EXCHANGE DUE TO THE LENGTH OF TIME THE ORIGINAL LINER WAS INSITU, THE SURGEON DECIDED TO PUT A NEW LINER IN. CUP WAS SOLID. SURGICAL DELAY IS UNKNOWN.

  Patient problems: Fall; Limb Fracture

  MAUDE report 17594594 ↗
• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR COMPLAINT RECEIVED AD 12 JUL 2023. PATIENT WAS REVISED DUE TO PAIN. DOI: ON (B)(6) 2008, DOR: ON (B)(6) 2023, LEFT.

  Patient problems: Pain

  MAUDE report 17372467 ↗
• InjuryMay 31, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF FEMORAL STEM WITH METAL ON METAL LINER REMOVAL. ACETABULAR CUP WAS RETAINED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2008. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17030863 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2017, DATE OF REVISION: (B)(6) 2023, (LEFT HIP). TREATMENT: REVISION; STEM, HEAD AND SHELL WERE REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 16814778 ↗
• InjuryFeb 23, 2023Migration; Migration

  THE PATIENT SUFFERED A PRIOR FALL AND FEMORAL STEM ULTIMATELY SUBSIDED. PATIENT UNDERWENT HIP REVISION AND HAD PRIOR HARDWARE REMOVED AND REPLACED WITH A RECLAIM FEMORAL STEM AND BIPOLAR HEAD FOR STABILITY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall

  MAUDE report 16427701 ↗
• InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16427517 ↗