CORAIL L20310Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 10603295258018), received between Jun 12, 2013 and Oct 25, 2024 — classified as 52 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (15 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 25 most recent of 56 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE AFFECTED SIDE INVOLVED WAS THE RIGHT HIP. THERE WAS NO PATIENT CONSEQUENCE/S AND NO SURGICAL DELAY REPORTED.

  Patient problems: Pain

  MAUDE report 20532957 ↗
• InjuryFeb 21, 2024Osseointegration Problem; Osseointegration Problem

  A. WAS THERE ANY SURGICAL DELAY ? NO. B. PLEASE CLARIFY IF STEM LOOSENING WAS CONFIRMED. THE LOOSENING OF THE STEM WAS CONFIRMED, AS (B)(6) WAS ABLE TO REMOVE IT WITHOUT ANY PROBLEM.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 18748142 ↗
• 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 18602954 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED: A, WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO B. IT WAS STATED THAT THE CORAIL PINNACLE METALOSE IN THE EVENT DESCRIPTION. YES, ULTAMET. C. PLEASE CLARIFY IF THERE WAS IMPLANT LOOSENING ELEVATED METAL IONS OR FOREIGN BODY REACTION, ETC. PLEASE KINDLY PROVIDE DETAILS. YES.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 18181841 ↗
• InjuryOct 18, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration

  PATIENT HAD PRIMARY COLLARLESS CORAIL IMPLANTED WITH DELTA MOTION CUP. REASON FOR REVISION WAS DUE TO LOOSENING CAUSING PAIN FOR THE PATIENT. X-RAYS SHOW RADIOLUCENT LINES AROUND THE CORAIL STEM WITH THICKENING OF THE CORTICES CLOSE TO THE TIP OF THE STEM, EVIDENCE OF WINDSCREEN WIPER EFFECT. ON DISCUSSION WITH [SURGEON], THIS WAS ONE OF HIS EARLY CASES WHERE HE USED CORAIL AND BELIEVES TO WAS TOO SMALL AND THIS MAY HAVE CONTRIBUTED TO THE SUBSIDENCE. WORTH NOTING THAT THE DIAPHYSIS WAS QUITE NARROW AND WHEN HE WAS AN EARLY USER MAY HAVE UNKNOWINGLY UNDERSIZED THE STEM AT THE TIME DUE TO BEING "HUNG UP" DISTALLY. SIZE 10 STEM WAS REMOVED AND SIZE 13 STANDARD CORAIL REVISION STEM REPLACED. DUE TO THE SUBSIDENCE AND TO RESTORE LEG LENGTH AND STABILITY, SIZE 40 +8.5 HEAD WAS USED. DOI: (B)(6) 2012. DOE: (B)(6) 2023.

  Patient problems: Inadequate Osseointegration; Pain; Physical Asymmetry

  MAUDE report 17959536 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PC WAS CREATED TO CAPTURE THE EVENT: ELEVATED CHROMIUM LEVEL AFTER FIRST REVISION. DOI: (B)(6) 2007 STEM. DOI: (B)(6) 2022 HEAD.

  Patient problems: Metal Related Pathology

  MAUDE report 17835971 ↗
• InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORD RECEIVED. THE PATIENT HAS BEEN HAVING PAIN IN BOTH HIPS SINCE REPLACEMENT. ON (B)(6) 2011, PATIENT CAME WITH A MYSTERIOUS RASH OVER HER FACE AND CHEST AND EDEMA. SHE WAS HAVING DIFFICULTY WITH AMBULATION AND HAD A REFERRAL FOR ALLERGIST TO SEE IF SHE MAY BE HAVING METAL ALLERGY BECAUSE OF THE EXTENSIVENESS OF RASH. DOI: (B)(6) 2009. DOR: UNKNOWN. LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Fatigue; Hypersensitivity/Allergic reaction; Metal Related Pathology; Numbness; Pain; Rash; Swelling/ Edema

  MAUDE report 17669529 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE LITIGATION COMPLAINT RECEIVED AD (B)(6) 2023. ON (B)(6) 2015 PATIENT UNDERWENT A REVISION SURGERY DUE TO SEVERE PAIN, DISCOMFORT, INFLAMMATION, SQUEAKING, ELEVATED COBALT AND CHROMIUM LEVELS, FRICTION AND WEAR BETWEEN THE METAL HEAD AND METAL LINER CAUSED LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL IONS. DURING THE PROCEDURE, IT WAS FURTHER DISCOVERED THAT SHE HAD DEVELOPED SIGNIFICANT METALLOSIS AROUND THE HIP WITH ACCOMPANYING TISSUE DAMAGE. DOI: (B)(6) 2008. DOR: (B)(6), 2015. LEFT HIP.

  Patient problems: Cramp(s) /Muscle Spasm(s); Discomfort; Fatigue; Foreign Body Reaction; Inflammation; Metal Related Pathology; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 17661071 ↗
• InjuryMay 22, 2023Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE WAS NO SURGICAL DELAY REPORTED.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 16975010 ↗
• InjuryMar 31, 2023Osseointegration Problem; Osseointegration Problem

  RIGHT HIP REVISION FOR PAIN DUE TO NO INTEGRATION OF THE FEMORAL STEM. DOI: (B)(6) 2021. DOR: (B)(6) 2023. RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 16655302 ↗
• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  PATIENT UNDERWENT PRIMARY RIGHT TKR ON (B)(6) 2009 WHERE A CORAIL STEM WITH A MOM PINNACLE LINER ARTICULATION WAS UTILIZED, DUE TO THE PATIENTS YOUNG AGE. PATIENT HAS PRESENTED WITH ONGOING PAIN (IT IS NOT KNOW WHETHER THE PATIENT HAS ELEVATED IRON LEVELS OR ANY OTHER SYMPTOMS ASSOCIATED WITH METALOSIS). A DECISION WAS MADE TO OPEN THE HIP AND IF POSSIBLE REPLACE THE MOM LINER WITH A PINNACLE DUAL MOBILITY OR A POLY LINER. ON OPENING THE KNEE, SLIGHTLY BLACKENED TISSUE WAS FOUND SUPERFICIAL TO THE GREATER TROCHANTER (AROUND THE TROCHANTERIC BURSA), BUT LITTLE STAINED TISSUE WAS FOUND WITHIN THE JOINT. THE METAL LINER WAS REMOVED ALONG WITH THE METAL 36MM FEMORAL HEAD. THE WOUND WAS IRRIGATED AND WASHED OUT (THERE WAS NO EVIDENCE OF INFECTION) AND MULTIPLE SAMPLES TAKEN. A PINNACLE DUAL MOBILITY LINER WAS INSERTED ALONG WITH A DUAL MOBILITY HEAD AND A NEW 22MM METAL HEAD. THE CORAIL STEM WAS LEFT IN SITU AND APPEARED TO BE WELL FIXED. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? UNKNOWN. IF YES, PLEASE DESCRIBE. BUT MOST LIKELY MOM / METALOSIS. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DE

  Patient problems: Foreign Body Reaction; Metal Related Pathology; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 15994882 ↗
• InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE MOM LITIGATION RECORD RECEIVED. LITIGATION ALLEGES HEAVY METAL POISONING FROM TOXIC HEAVY METALS RESULTING TO INJURIES IN THE MUSCLE, TISSUE, SCAR TISSUE FORMATION, METALLOSIS, METAL WEAR, LIMITED ADL, PAIN, EMOTIONAL TRAUMA AND DISTRESS. DOI: UNKNOWN; DOR: (B)(6) 2022; HIP UNKNOWN.

  Patient problems: Adhesion(s); Distress; Foreign Body Reaction; Joint Laxity; Loss of Range of Motion; Metal Related Pathology; Pain; Scar Tissue; Swelling/ Edema; Synovitis; Unspecified Tissue Injury

  MAUDE report 15916349 ↗
• MalfunctionSep 8, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT FELL AND LOOSENING OF THE CORAIL 10 STEM AT BONE TO IMPLANT INTERFACE. SURGEON REMOVED STEM AND HEAD. PINNACLE CUP AND LINER REMAINED IMPLANTED. AN ACTIS STEM AND A NEW 40 MM HEAD WERE IMPLANTED. DOI: UNKNOWN. DOR: (B)(6). AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Inadequate Osseointegration

  MAUDE report 15377826 ↗
• MalfunctionMay 31, 2022Expiration Date Error; Expiration Date Error

  THE EXPIRED PRODUCT WAS USED DURING THE HIP SURGERY. THE EXPIRY DATE OF PRODUCT WAS 2/28/2022. NO OTHER INFORMATION ABOUT THE PATIENT CONDITION IS AVAILABLE AT THIS MOMENT. PRODUCT IS IMPLANTED IN PATIENT BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14548650 ↗
• InjuryMay 11, 2022Osseointegration Problem; Osseointegration Problem

  REVISION COMPLETED TO ADDRESS PAIN. PATIENT HAS PRESENTED IN THE PAST YEAR OR TWO WITH PAIN IN THE FEMORAL AREA. BONE SCANS AND X-RAYS SHOW INCREASED UPTAKE AROUND THE FEMORAL STEM AND PROGRESSIVE RADIOLUCENT LINES. A DECISION WAS TAKEN REVISE THE FEMORAL STEM AND REPLACE THE MOM LINER WITH A DUAL MOBILITY. THE FEMORAL STEM WAS FOUND TO BE LOOSE. NON OVERT EVIDENCE OF METALLOSIS WAS PRESENT. THE STEM WAS REMOVED QUITE EASILY, THE METAL PINNACLE LINER REMOVED AND REPLACED WITH A PINNACLE DUAL MOBILITY LINER AND THE STEM REPLACED WITH A ZB ARCOS STEM.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Pain

  MAUDE report 14354765 ↗
• InjuryApr 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR FAILED LEFT HIP. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 14218105 ↗
• MalfunctionSep 13, 2021Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT THE KHO SIZE 10 CORAIL STEM WAS FOUND TO HAVE A PACKAGE EXPIRATION DATE OF 6/30/2021 AFTER PATIENT WAS CLOSED AND IN RECOVERY. DOE: (B)(6) 2021 AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12460609 ↗
• InjuryNov 18, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED FOR SUSPECTED LOOSE CORAIL STEM. CORAIL WAS FOUND TO BE GROSSLY LOOSE. REVISED TO A COMPETITOR STEM AND HEAD. THE PATIENT ALSO HAD METAL-ON-METAL LINER REVISED TO POLY. IT SHOULD ALSO BE NOTED THAT THIS WAS A CERAMIC HEAD ON METAL LINER. ORIGINALLY DONE ANOTHER SURGEON, LOCATION AND DATE UNKNOWN. NO FURTHER PATIENT INFORMATION AVAILABLE. LOOSENING AT THE BONE TO IMPLANT INTERFACE. NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10861311 ↗
• InjuryJun 29, 2020Loss of Osseointegration; Loss of Osseointegration

  AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED FOR MECHANICAL LOOSENING OF LEFT TOTAL HIP ARTHROPLASTY. IT WAS INDICATED THAT THE PATIENT PRESENTED WITH INCREASING HIP PAIN AND INABILITY TO AMBULATE WELL AND GETTING DIFFICULT TO WALK EVEN WITH MAXIMUM ASSISTANCE. OPERATIVE NOTES REPORTED THAT THERE APPEARS TO BE A SUBACUTE HEMATOMA WHICH WAS IRRIGATED. THE ENTIRE STE AND HEAD WAS REMOVED AS A SINGLE PIECE BY HAND AS IT WAS GROSSLY LOOSE. DOI: (B)(6) 2006; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Hematoma; Inadequate Osseointegration; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 10209217 ↗
• InjuryApr 29, 2020Degraded; Degraded

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT HIP TO ADDRESS ADVERSE LOCAL TISSUE REACTION/ADVERSE REACTION TO METAL DEBRIS. DATE OF IMPLANTATION: (B)(6) 2005; DATE OF REVISION: (B)(6) 2019; (RIGHT HIP). TREATMENT: METAL LINER AND METAL HEAD REVISED.

  Patient problems: Foreign Body Reaction; Necrosis; No Code Available

  MAUDE report 10010657 ↗
• InjuryMar 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT FELL AND BROKE FEMUR AROUND FEMORAL COMPONENT.

  Patient problems: Bone Fracture(s); Fall; No Code Available

  MAUDE report 9780197 ↗
• InjuryJan 31, 2020Loss of Osseointegration; Loss of Osseointegration

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED FOR FAILED LEFT HIP THA WITH LOOSENING. OPERATIVE NOTES REPORTED THAT THERE WAS A THICK WHITE OR TANNISH FLUID. THE FLUID WAS IRRIGATED, WHICH MOST PROBABLY WAS A FOREIGN BODY REACTION TO OSTEOLYSIS. THE FEMORAL COMPONENT WAS LOOSE. HAS OSTEOLYSIS AROUND THE STEM WITH SOME HOLES FILLED WITH FIBROUS TISSUE. THERE WAS MINIMAL BONE GROWTH IN THE CUP AS WELL. DOI: (B)(6) 2006; DOR: (B)(6) 2011; LEFT.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; No Code Available; Osteolysis

  MAUDE report 9653756 ↗
• InjuryDec 3, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  LOOSE CORAIL IMPLANT REQUIRED REVISION TO RECLAIM.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9403791 ↗
• InjuryNov 19, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2015 : DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9340882 ↗
• InjurySep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019 VIA THA. IT WAS REPORTED THAT THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) , 2019 BY EXPLANTING THE STEM (P/N: L20310), THE HEAD (P/N: 136532330) DUE TO POSTOPERATIVE INFECTION. THE SURGERY WAS COMPLETED WITHIN A 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Not Applicable; Unspecified Infection

  MAUDE report 9008448 ↗