CORAIL 3L92516Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295168829), received between Feb 2, 2018 and Aug 18, 2026 — classified as 10 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (2 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2026Osseointegration Problem

  It was reported that the pinnacle 62 cup and metal liner were removed because of metalosis. The Corail KS16 stem and ceramic head were also removed because stem was loose.DOI: Unknown.DOR: (b)(6) 2026.Affected side: Unknown.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration

  MAUDE report 50305640 ↗
• MalfunctionFeb 13, 2026Tear, Rip or Hole in Device Packaging

  INTRAOPERATIVELY - DAMAGE TO THE PACKAGING AND THE DRILL BIT IS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337483 ↗
• MalfunctionDec 31, 2024Missing Information; Missing Information

  IT WAS REPORTED THAT DURING A RECENT PACKAGING INTEGRITY CONFERENCE, IT WAS IDENTIFIED THAT SIX ITEMS ARE WITHOUT TRACEABILITY AND NATIONALIZATION LABELS. IT WAS NOT POSSIBLE TO DETERMINE EXACTLY WHEN THE LABELS WERE LOST, BUT THEIR ABSENCE WAS DETECTED DURING THE VERIFICATION PROCESS. WHEN THESE PRODUCTS WERE RECEIVED IN STOCK, WITH THE RECEIPT NOTE INVOICE (FIRST ENTRY), THERE WAS NO CLAIM RECORD REGARDING THE LACK OF LABELS, WHICH LEADS US TO CONCLUDE THAT THE ITEMS WERE PROPERLY LABELED AT THE ENTRANCE.

  Patient problems: Insufficient Information

  MAUDE report 21048388 ↗
• MalfunctionJan 29, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PACKAGING WAS DAMAGED UPON RECEIPT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18602966 ↗
• InjuryDec 18, 2020Degraded; Naturally Worn; Degraded; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO REMOVE METAL ON METAL LINER. DOI: UNKNOWN. DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Osteolysis; Pain

  MAUDE report 11038183 ↗
• InjuryJul 21, 2020Corroded; Corroded

  PATIENT WAS REVISED TO ADDRESS METALLOSIS. METAL HEAD AND METAL LINER WERE REMOVED. SURGEON NOTED ABDUCTOR LOSS DUE TO METALLOSIS. CORROSION ON THE STEM. DOI: UNKNOWN, DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: Edema; Erosion; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Inflammation; Necrosis; No Code Available

  MAUDE report 10301305 ↗
• MalfunctionSep 25, 2019Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT THE IMPLANT WAS EXPIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9120627 ↗
• InjuryJan 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS A MALPOSITIONED METAL LINER AND LEG LENGTH DISCREPANCY. OSTEOLYSIS WAS ALSO REPORTED. LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, SWELLING, INFLAMMATION, INFECTION, AND DAMAGE TO SURROUNDING BONE AND TISSUE, DISLOCATION, AND LACK OF MOBILITY. PPF ALLEGED ELEVATED METAL IONS. DOI: (B)(6) 2007; DOR: (B)(6) 2011 (RIGHT HIP).

  Patient problems: Inflammation; Limited Mobility Of The Implanted Joint; No Code Available; Osteolysis; Pain; Swelling; Test Result; Unspecified Infection

  MAUDE report 8211888 ↗
• InjuryNov 20, 2018Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES DISLOCATION, INFECTIONS, ELEVATED METAL IONS AND PULMONARY EMBOLISM. DOI: (B)(6) 2010 - DOR: (B)(6) 2010 (RIGHT HIP).

  Patient problems: Pulmonary Embolism; Test Result; Unspecified Infection

  MAUDE report 8088594 ↗
• InjuryNov 19, 2018Biocompatibility; Biocompatibility

  PATIENT WAS REVISED TO ADDRESS DISLOCATION. UPDATED: AD 23 MAY 2018: RECEIPT OF PPF AND STICKER SHEETS. PPF ALLEGES DISLOCATION, METAL WEAR, METALLOSIS, AND ELEVATED METAL IONS. ADDED STEM DUE TO ELEVATED METAL IONS, DOB, LAW FIRM, LAWYER, PATIENT HARM AND REVISION HOSPITAL.

  Patient problems: Test Result; Tissue Damage

  MAUDE report 8084151 ↗
• InjuryOct 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR REVISION; ASR XL; RIGHT HIP. REASON(S) FOR REVISION: ALVAL/SOFT TISSUE REACTION. DOI: (B)(6) 2009; DOR: (B)(6) 2018.

  Patient problems: Test Result; Tissue Damage

  MAUDE report 7938600 ↗
• InjuryAug 10, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  ASR REVISION. ASR XL- LEFT. REASON(S) FOR REVISION: COMPONENT LOOSENING.

  Patient problems: Inadequate Osseointegration; Not Applicable

  MAUDE report 7772278 ↗
• InjuryJun 12, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  UPDATE (B)(6) 2018: ASR MEDICAL RECORDS RECEIVED.  AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF THE LEFT HIP JOINT ENDOPROSTHESIS ACETABULUM, METALLOSIS, AND FEMUR FRACTURE. REVISION NOTES REPORTED THE HEAD WAS BROKEN AWAY, STABLE STEM, AND LOOSE ACETABULUM REMOVED. LAB RESULT SHOWS METAL ION LEVELS ABOVE 7 PPB.  DOI: (B)(6) 2009; DOR: (B)(6) 2014; LEFT HIP.

  Patient problems: Not Applicable; Pain; Test Result; Tissue Damage

  MAUDE report 7591152 ↗
• InjuryFeb 2, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  PATIENT WAS REVISED TO ADDRESS SUBSIDENCE. THE STEM WAS REPORTEDLY UNDERSIZE FOR PATIENT. DOI: (B)(6) 2017; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7236979 ↗