CORAIL L20316Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295258070), received between Nov 4, 2017 and Jan 13, 2025 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND HAD A PERIPROSTHETIC FRACTURE. THE PATIENT UNDERWENT REVISION TO RECLAIM. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 21138895 ↗
• InjuryApr 4, 2024Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL STEM CAUSED BY PERIPROSTHETIC FRACTURE AT THE NON-CEMENTED INTERFACE. DOI: UNKNOWN. DOR: ON (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 19042394 ↗
• 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 18603066 ↗
• InjuryMar 10, 2022Osseointegration Problem; Osseointegration Problem

  REVISION COMPLETED DUE TO LOOSENING. SURGEON REMOVED STEM, METAL LINER AND FEMORAL HEAD. DOI: (B)(6) 2009. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13722502 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS REVIEWED: ON (B)(6) 2021, PATIENT RECEIVED A RIGHT ANTERIOR APPROACH TOTAL HIP ARTHROPLASTY TO ADDRESS END-STAGE ARTHRITIS, UTILIZING INGROWTH CORAIL STEM AND PINNACLE CUP, WITH ALTRX POLYETHYLENE LINER AND CERAMIC FEMORAL HEAD. THERE WERE NO COMPLICATIONS. ON (B)(6) 2021, PATIENT PRESENTED IN THE OFFICE WITH SUDDEN ACUTE ONSET OF CALF PAIN, WITH DIFFICULTY WALKING. THIS WAS SUSPICIOUS FOR POSSIBLE DEEP VEIN THROMBOSIS FOLLOWING A VENOUS DOPPLER EXAMINATION ON (B)(6) 2021, IT WAS DETERMINED THAT THE PATIENT DID HAVE A CONFIRMED NON-OCCLUSIVE DEEP VEIN THROMBOSIS OF THE POSTERIOR TIBIAL VEIN, EXTENDING FROM THE CALF TO THE ANKLE. ATTENDING SURGEON PRESCRIBED ELIQUIS 10 MG BID FOR 7 DAYS, THEN 5 MG BID AFTER THAT, WITH REDUCTION IN ALL ACTIVITIES UNTIL SEEN BY FAMILY PHYSICIAN TO RESUME CARE.

  Patient problems: Ambulation or Postural Difficulties; Pain; Thrombosis/Thrombus

  MAUDE report 11888542 ↗
• InjuryJul 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PCF AND MEDICAL RECORDS RECEIVED. PCF HAS NO ALLEGATIONS REPORTED. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED DUE TO SEVERE ADVERSE LOCAL TISSUE REACTION WITH METAL DEBRIS AND MASSIVE OSTEOLYSIS. OPERATIVE NOTES INDICATED ELEVATED METAL LEVEL, A LARGE AMOUNT OF NECROTIC REACTIVE DEBRIS AND BONE LOSS. THERE WAS A LARGE AMOUNT OF FLUID IN THE JOINT AND A LARGE AMOUNT OF ABNORMAL REACTIVE TISSUE AND ALSO REPRESENTED SOME NECROTIC MUSCLE. THERE WAS SOME SCAR TISSUE IDENTIFIED IN THE PERIFORMIS. DOI: (B)(6) 2008, DOR: (B)(6) 2020, (LEFT HIP).

  Patient problems: Adhesion(s); Edema; Foreign Body Reaction; Injury; Necrosis; No Code Available; Osteolysis; Pain; Test Result

  MAUDE report 10234370 ↗
• InjuryDec 12, 2019Fracture; Use of Device Problem; Malposition of Device; Fracture; Use of Device Problem; Malposition of Device

  LITIGATION ALLEGES THAT PATIENT HAS EXPERIENCED SEVERE PAIN. ADDITIONALLY, IT IS ALLEGED THAT TOXIC AMOUNTS OF COBALT AND CHROMIUM ARE MAKING THEIR WAY INTO PATIENT'S HIP JOINT AND BLOOD STREAM. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR AND METALLOSIS. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESSED FAILED PAINFUL RIGHT METAL ON METAL TOTAL HIP ARTHROPLASTY. OPERATIVE NOTES INDICATED MILDLY NECROTIC TISSUE, UNDERBELLY OF THE MUSCLE, ALL METALLIC-STAINED TISSUE, DAMAGE TISSUE AND SYNOVALIZED METAL-STAINED TISSUE REMOVED WITH BOVIE ELECTROCAUTERY. THE TRUNNION ITSELF APPEARED PRISTINE WITH DAMAGE TO THE POSTERIOR SIDE F THE NECK. THE ANTEVERSION OF THE STEM APPEARED TO BE 10-15 DEGREES. THE ACETABULAR COMPONENT IS ANTEVERTED AND SLIGHTLY VERTICAL. DOI: (B)(6) 2007; DOR: (B)(6) 2012 (RIGHT HIP).

  Patient problems: Foreign Body Reaction; Necrosis; No Code Available; Pain; Test Result; Tissue Damage

  MAUDE report 9458155 ↗
• InjuryJan 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES PSEUDOTUMOR, METAL WEAR AND METALLOSIS AND ELEVATED METAL IONS.

  Patient problems: No Code Available; Test Result; Tissue Damage

  MAUDE report 8266749 ↗
• InjuryOct 4, 2018Naturally Worn; Naturally Worn

  REVISION NOTE REPORTED STEM WEAR. STEM WAS NOTED TO BE WELL-FIXED AND NOT REMOVED. DOI: (B)(6) 2017; (B)(6) 2018; UNKNOWN HIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7935533 ↗
• InjuryFeb 20, 2018Corroded; Corroded

  ALLEGES ELEVATED CHROMIUM AND COBALT LEVELS IN BLOOD AND MRI RESULTS SHOWED NECROSIS AT THE LEFT HIP JOINT. IT WAS ALSO ALLEGED THAT THERE WAS LOOSE HIP, PAIN, METALLOSIS, DISCOMFORT, INJURIES, REDUCED MOBILITY, AND EMOTIONAL DISTRESS. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, PATIENT WAS REVISED TO ADDRESS FAILED LEFT METAL ON METAL TOTAL METALLOSIS AND OBESITY. OPERATIVE NOTES REPORTED OF SIGNIFICANT METALLOSIS, PSEUDOCAPSULAR FORMATION, SIGNIFICANT TRUNNIONOSIS/ CORROSION, BLACKENING OF THE TRUNNION, AND EXTENSIVE BLACK CORROSIVE APPEARING MATERIAL BEHIND THE METAL LINER. LABORATORY RESULT FOR METAL IONS WERE BELOW 7. CHROMIUM: 1.6 PBB. COBALT: 3.2 PBB. DOI: (B)(6) 2009; DOR: (B)(6) 2015; LEFT HIP ((B)(6)).

  Patient problems: Discomfort; Limited Mobility Of The Implanted Joint; Necrosis; Pain; Tissue Damage

  MAUDE report 7281821 ↗
• InjuryNov 4, 2017Naturally Worn; Appropriate Device Problem Term/Code Not Available; Naturally Worn; Appropriate Device Problem Term/Code Not Available

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS METALLOSIS. OPERATIVE FINDINGS INCLUDE MODERATE AMOUNT OF METALLOSIS DEBRIS WITH MINIMAL TRUNNION WEAR. THE STEM WAS RETAINED AND ASR XL COMPONENTS WERE EXPLANTED. DOI: (B)(6) 2008 - DOR: (B)(6) 2017 (RIGHT HIP).

  Patient problems: Discomfort; Foreign Body Reaction; Host-Tissue Reaction; No Code Available; Pain

  MAUDE report 7002209 ↗