CORAIL 3L93713Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10603295168904), received between Jul 7, 2017 and May 5, 2026 — classified as 43 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (9 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 45 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION ASSOCIATED WITH PROSTALAC. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE-LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25086567 ↗
• InjuryAug 21, 2025Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SCREW AND CEMENT INVOLVED. IT IS A CEMENTLESS PRODUCT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22861162 ↗
• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SUFFERING FROM PERSISTENT RIGHT HIP PAIN. PATIENT HAD A PINNACLE METAL ON METAL LINER AND CORAIL STEM. REVISION WAS PERFORMED. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 22099082 ↗
• InjuryJun 17, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO STEM BEING LOOSE AND A GREATER TROCHANTER FRACTURE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 19554473 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT RECEIVED R THJR. THIS BECAME INFECTED AND A DAIR WAS COMPLETED. DAIR WAS UNSUCCESSFUL. ALL COMPONENTS WERE REMOVED AND THE JOINTS WAS REVISED. DOI: (B)(6) 2024. DOE: (B)(6) 2024. AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 19449035 ↗
• InjuryApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD HIP REPLACEMENT FAILED AND PATIENT FELL AND THEN HAD EMERGENCY SURGERY FOR 6 HOURS. THEY HAD TO BREAK PATIENT'S FEMUR TO GET THE OLD ONE OUT. PATIENT'S FAMILY WERE NOT CALLING A LAWYER YET BECAUSE THEY WANT TO SPEAK TO SOMEONE REGARDING THIS. THIS HAPPENED ON (B)(6) 2024. HIP REPLACEMENT 2020 AND REVISION DUE TO LEG DISCREPANCY DUE WAS 2022. DOCTOR TOLD THAT IT WAS MADE BY DEPUY.

  Patient problems: Ambulation or Postural Difficulties; Fall; Limb Fracture; Physical Asymmetry

  MAUDE report 19153769 ↗
• InjuryFeb 26, 2024Osseointegration Problem; Osseointegration Problem

  ON (B)(6) 2022 AN NM2 BONE SCAN WAS ORDERED DUE TO MECHANICAL LOOSENING OF INTERNAL RIGHT HIP PROSTHETIC JOINT. THE SCAN SHOWS A SUBTLE INCREASED RADIOTRACER ACTIVITY TIP IN THE RIGHT FEMORAL SHAFT COMPONENT OF THE PROSTHESIS. THE PATIENT WILL RECEIVE A LETTER NOTIFYING THEM TO FOLLOW UP WITH THEIR PHYSICIAN. DOE: (B)(6) 2022.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18778113 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NON MOM MEDICAL RECORDS ON ATTACHMENTS (B)(4) MEDICAL RECORDS AD 1 SEP 2023 (1), (B)(4) MEDICAL RECORDS AD (B)(6) 2023 (1), AND (B)(4) MEDICAL RECORDS AD (B)(6) 2023 (2) WERE REVIEWED BY A CLINICIAN FOR ADVERSE EVENTS. ON (B)(6) 2019, THE PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY UTILIZING A CEMENTLESS CORAIL STEM (PRODUCT CODE 3L93173) AND CERAMIC HEAD (136536330) WITH COMPETITOR CUP AND LINER. THERE WERE NO INTRAOPERATIVE COMPLICATIONS ON (B)(6) 2019, THE PATIENT IS ADMITTED TO THE HOSPITAL FOR PAIN, SHAKING, FEELING COLD/CHILLED, CLAMMY WITH A LEFT INCISION THAT WAS RED AND SWOLLEN. HE WAS TRANSFERRED TO ANOTHER HOSPITAL WHERE AN I&D WAS PERFORMED WITH REMOVAL OF THE LEFT COMPETITOR CUP/LINER AND DEPUY STEM AND HEAD. HE WAS PROVIDED A SPACER MADE OF COMPETITOR CEMENT AND GIVEN IV ANTIBIOTICS VIA PICC LINE. ON (B)(6) 2019, THE PATIENT BECAME FEBRILE, HYPOTENSIVE AND TACHYCARDIC REQUIRING HOSPITALIZATION AND UNDERWENT ANOTHER REVISION WHERE THE SPACER MADE OF COMPETITOR CEMENT WAS REMOVED, A HEMATOMA WAS EVACUATED AND DEPUY¿S PROSTALAC WAS PLACED. ON (B)(6) 2019, THE PATIENT UNDERGOES A LEFT HIP REIMPLANTATION WHERE A COMPETITOR CUP/LINER WAS PLACED AND DEPUY STEM (L20314) A

  Patient problems: Arrhythmia; Erythema; Fever; Hematoma; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 18143743 ↗
• InjuryJun 19, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAINFUL HIP. THERE WAS A LOOSENING OF STEM-NON CEMENTED. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 17152933 ↗
• InjuryMay 24, 2023Osseointegration Problem; Osseointegration Problem

  THE SURGEON WAS REVISED THE PATIENT DUE TO HIP PAIN. WHEN THE GOT INSIDE THE JOINT THE STEM WAS LOOSE. THE SURGEON REMOVED STEM, HEADBALL AND LINER AND CONVERT TO REVISION STEM AND DM CONSTRUCT. NO SURGICAL DELAY OR CEMENT WAS USED. DOI: (B)(6) 2021, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 16991015 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT RIGHT CORAIL/PINNACLE TOTAL HIP REPLACEMENT THREE YEARS AGO. PRESENTED BACK TO GP WITH COMPLAINT OF PAIN. X-RAY TAKEN WHICH SHOWED AN AREA OF SINUS TRACKING IN THE BONE SUSPICIOUS OF INFECTION. PROCEDURE REMOVAL OF CORAIL/PINNACLE HIP REPLACEMENT, RIGHT AND INSERTION OF 'KIWI SPACER', IE LOOSELY CEMENTED C-STEM AND MARATHON CEMENTED CUP. UPON REMOVING THE CORAIL STEM THE SURGEON STATED HE COULD SEE 'AN AREA OF PUS' IN THE FEMORAL CANAL. DOI: UNKNOWN, DOR: (B)(6) 2023, RIGHT HIP.

  Patient problems: Cyst(s); Pain; Unspecified Infection

  MAUDE report 16252768 ↗
• InjuryJun 17, 2022Off-Label Use; Off-Label Use

  ON (B)(6) 2022, A TOTAL HIP REPLACEMENT WAS IMPLANTED AT KSSH BY DR. (B)(6). IN THE COURSE OF THE PROCEDURE, AN INFECTION DEVELOPED, WHICH IS WHY A PROSTHESIS-PRESERVING REVISION WAS PERFORMED ON AND ANTIBIOTIC TREATMENT WAS STARTED. IN CASE OF THERAPY FAILURE THE PATIENT WAS TRANSFERRED TO THE KSW FOR FURTHER TREATMENT ((B)(6) 2022). IT WAS FOUND THAT A PROSTHESIS STEM FOR UNCEMENTED ANCHORAGE HAD BEEN CEMENTED IN. WAS CEMENTED IN. FOR 2 REASONS THIS LEADS TO A PREDICTABLE FAILURE: ON THE ONE HAND BECAUSE THE STEM IS COATED WITH HYDROXYAPATITE, AND SECONDLY BECAUSE THE STEM IS MADE OF TITANIUM. THE HYDROXYAPATITE IS A VERY HARD SUBSTANCE, AND CAN CAUSE MASSIVE ABRASION BY FRICTION UNDER PHYSIOLOGICAL MASSIVE ABRASION OF THE CEMENT DUE TO FRICTION UNDER PHYSIOLOGICAL LOADS. THE HYDROXYAPATITE DISSOLVES OVER THE COURSE OF THE MONTHS, THE CEMENT ANCHORAGE WOULD LOOSEN ACCORDINGLY AND FAIL. TITANIUM SHAFTS ARE KNOWN TO FAIL WHEN CEMENTED IN, EXCEPT IN VERY FEW MODELS, BECAUSE THE ABRASION ON THE SURFACE LEADS TO A CONTINUOUS SURFACE LEADS TO CONTINUOUS OXIDATION AND CORRESPONDING SWELLING OF THE STEM, UNTIL THE CEMENT MANTLE OR THE BONE IS CRACKED. IT WAS THEREFORE DECIDED NOT TO TREA

  Patient problems: Unspecified Infection

  MAUDE report 14732520 ↗
• InjuryMay 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE MOM LITIGATION RECORD RECEIVED. PATIENT ALLEGES ELEVATED METAL ION, SUFFERED INJURY TO MUSCLE AND TISSUE, SUFFERED ADITIONAL SCAR TISSUE FORMATION, PAIN, FLUID COLLECTION, PSEUDOTUMOR, TISSUE DESTRUCTION, METAL WEAR, METAL POISONING, LOSS OF ENJOYMENT OF LIFE, AND LIMITATION OF DAILY ACTIVITIES, DISABILITY, AND EMOTIONAL DISTRESS. DOI: (B)(6) 2010. DOR: UNK. (RIGHT HIP).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Metal Related Pathology; Muscle/Tendon Damage; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 14269253 ↗
• InjuryOct 1, 2021Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE AFFECTED SIDE INVOLVED IN THIS EVENT WAS THE RIGHT SIDE.

  Patient problems: Inadequate Osseointegration; Pain; Unspecified Infection

  MAUDE report 12562424 ↗
• InjurySep 29, 2021Degraded; Degraded

  ASR CLAIM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED PAINFUL LEFT HIP WITH METAL ON METAL BEARING WITH TRUNNION METALLOSIS THAT MOST LIKELY CAUSE OF THE IRRITATION. MRI SHOWED A LARGE CYST LIKE LESIONS COMPATIBLE WITH THE METAL ON METAL BEARING. THERE WAS NOT AN ABNORMAL AMOUNT OF WEAR, ALTHOUGH THERE WERE SOME SMALL BURNISHED MARKS ON THE FEMORAL HEAD. THE TRUNNION WAS QUITE COATED WITH A THICK BLACK RESIDUE. ACETABULAR CUP WAS SOLIDLY FIXED, LIGHTLY BURNISHED BUT NOT SCRATCHED. DOI: (B)(6) 2006. DOR: (B)(6) 2014, LEFT HIP.

  Patient problems: Cyst(s); Foreign Body Reaction; Hypersensitivity/Allergic reaction; Pain

  MAUDE report 12547126 ↗
• InjurySep 7, 2021Osseointegration Problem; Osseointegration Problem

  PATIENT RECEIVED A REVISION TO TREAT PAIN AND INSTABILITY SECONDARY TO A FRACTURED CERAMIC HEAD, A WORN AND CHIPPED CERAMIC LINER, AND A STEM LOOSENED AT THE IMPLANT TO BONE INTERFACE. HEAD FRACTURE REVISED, CERAMIC LINER ALSO DAMAGED. CORAIL EXTRACTION DEVICE DAMAGED UPON EXTRACTION, SNAPPED IN THE STEM. THERE WAS A SURGICAL DELAY WHILE THE SURGEON LOCATED ALL OF THE PIECES OF THE FEMORAL HEAD. NO ADDITIONAL INFORMATION WAS PROVIDED. DOI: UNKNOWN; DOR: (B)(6) 2021; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Joint Laxity; Pain

  MAUDE report 12432095 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. ALL IMPLANTS REMOVED. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2019, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

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

  MAUDE report 12200677 ↗
• InjuryJun 9, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED SO THE DOCTOR TOOK THE STEM OUT AND PUT IN A NEW STEM AND HEAD. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2020, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

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

  MAUDE report 11969464 ↗
• InjuryApr 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AS PATIENT DISLOCATED IN POST OP SHORTLY AFTER SURGERY. DR. (B)(6) SCHEDULED REVISION TWO HOURS LATER. CHANGED HEAD, LINER AND CHANGED STEM FROM KLA TO A STD CORAIL. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 11713721 ↗
• InjuryApr 20, 2021Fracture; Fracture

  ADDITIONAL INFORMATION INDICATED THAT THE FRACTURE OF THE STEM WAS THE REASON FOR REVISION. AFFECTED SIDE WAS RIGHT HIP.

  Patient problems: Pain

  MAUDE report 11696186 ↗
• InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 11288357 ↗
• InjuryNov 10, 2020Loss of Osseointegration; Unintended Movement; Loss of Osseointegration; Unintended Movement

  IT WAS REPORTED THAT THE SURGEON STATED CORAIL STEM HAS SUBSIDED DUE TO PATIENT SIZE. IT WAS ALSO INDICATED THAT THE STEM WAS LOOSE AT BONE TO IMPLANT INTERFACE. STEM AND HEAD REMOVED. REPLACED WITH A RECLAIM AND NEW HEAD. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2020, RIGHT SIDE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10816880 ↗
• InjuryOct 23, 2020Loss of Osseointegration; Migration; Loss of Osseointegration; Migration

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL HIP TO ADDRESS ASEPTIC LOOSENING AND ADVERSE LOCAL TISSUE REACTION. DATE OF IMPLANTATION: (B)(6) 2008, DATE OF REVISION: (B)(6) 2020. TREATMENT: FEMORAL STEM, FEMORAL HEAD, AND ACETABULAR LINER REVISED.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Edema; Foreign Body Reaction; Inadequate Osseointegration; Inflammation; Muscular Rigidity; No Code Available; Pain

  MAUDE report 10727275 ↗
• InjurySep 2, 2020Fracture; Fracture

  AFFECTED SIDE: LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; No Code Available

  MAUDE report 10482533 ↗
• MalfunctionJul 16, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IMPLANTS WERE RETURNED DUE TO WET PACKAGING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10283919 ↗