CORAIL L20315Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295258063), received between Jan 28, 2014 and Jan 29, 2024 — classified as 18 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• 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 18603063 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. DOI-UNKNOWN, DOR- (B)(6) 2022, UNKNOWN HIP.

  Patient problems: Limb Fracture

  MAUDE report 13801390 ↗
• InjuryMar 29, 2021Osseointegration Problem; Osseointegration Problem

  REVISION OF A DEPUY CORAIL STEM. RIGHT SIDE. REASON FOR REVISION WAS DUE TO A PERI-PROSTHETIC FRACTURE CAUSING THE STEM TO BECOME LOOSE. THE STEM AND HEAD WERE REMOVED, AND A RECLAIM STEM AND A 36 +1.5 CERAMIC HEAD WERE IMPLANTED. CUP AND LINER WERE NOT IMPACTED.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 11584680 ↗
• InjuryMay 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PERIPROSTHETIC FRACTURE. REMOVED STEM. IMPLANTED REVISION STEM. DOI: (B)(6) 2014. DOR: (B)(6) 2020. RIGHT HIP.

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

  MAUDE report 10067244 ↗
• InjuryApr 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC FRACTURE. DOI: UNK. DOR: (B)(6) 2020, RIGHT HIP.

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

  MAUDE report 9929190 ↗
• InjuryDec 6, 2019Fracture; Fracture

  THE PATIENT HAD IN 2014 A HIP REPLACEMENT SURGERY THAT TODAY NEEDS TO BE REMOVED BECAUSE THE CORAIL PROSTHESIS HAS REPORTED NECK IMPLANT RUPTURE.

  Patient problems: No Code Available

  MAUDE report 9432793 ↗
• InjurySep 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATING A POSTTRAUMATIC PERIPROSTHETIC FRACTURE OF THE LEFT FEMUR PER- AND SUBTROCHANTERIC.

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

  MAUDE report 9083503 ↗
• InjuryApr 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECORD RECEIVED. PPF ALLEGES INFECTION. DOI: (B)(6) 2016; DOR: (B)(6) 2016; (LEFT HIP). SEE (B)(4) FOR THE FIRST REVISION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8546260 ↗
• InjuryMar 15, 2019Fracture

  SUBJECT ID: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR PERIPROSTHETIC FEMUR FRACTURE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE. DOI: (B)(6) 2019; DOE: (B)(6) 2019; (RIGHT HIP). TREATMENT INCLUDES ORIF.

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

  MAUDE report 8425860 ↗
• InjuryJan 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT THE PATIENT EXPERIENCED SEVERE PAIN AND DISCOMFORT, HAD ABNORMALLY HIGH LEVELS OF COBALT AND CHROMIUM, SUFFERED FROM INJURY, EMOTIONAL DISTRESS AND DISFIGUREMENT.

  Patient problems: Deformity/ Disfigurement; Discomfort; Injury; No Code Available; Pain; Test Result

  MAUDE report 8273934 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PAIN AND DECREASED RANGE OF MOTION. PPF ALLEGES ABDUCTOR MUSCLE REPAIR AND ELEVATED METAL IONS. DOI: (B)(6) 2010 - DOR: NONE REPORTED (RIGHT HIP).

  Patient problems: Loss of Range of Motion; Pain; Test Result; Tissue Damage

  MAUDE report 8202344 ↗
• InjurySep 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ASR REVISION , ASR XL ACETABULAR SYSTEM , RIGHT HIP , REASON(S) FOR REVISION: PAIN, ELEVATED BLOOD ION LEVELS. DOI: (B)(6) 2009; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable; Pain; Test Result

  MAUDE report 7909628 ↗
• InjuryMay 10, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT. -LITIGATION ALLEGES SEVERE PAIN, DISCOMFORT, INFLAMMATION, AND ELEVATED LEVELS OF COBALT CHROMIUM METAL IONS AND PARTICLES IN THE BLOOD AND TISSUE SURROUNDING THE IMPLANT. DOI: (B)(6) 2008 - DOR: NONE REPORTED; (RIGHT HIP). PATIENT IS A RESIDENT OF (B)(6). UPDATE: 11/2/2012- PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATE AD: 13 APR 2018-PFS, PPF, MEDICAL RECORD AND STICKER SHEET RECEIVED. PINNACLE PLAINTIFF FACT SHEET AND PLAINTIFF PROFILE FORM ALLEGES PAIN, INJURY AND DIFFICULTY WALKING. UPDATED COMPLAINT INFORMATION. DOI: (B)(6) 2008; DOR: NOT REVISED; RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Inflammation; Injury; No Code Available; Pain; Rash

  MAUDE report 7501991 ↗
• InjuryJan 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTED HEMATOMA. (B)(6) 2017. (B)(6) 2017. RIGHT HIP.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 7215076 ↗
• InjuryJan 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2017; RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 7206423 ↗
• InjurySep 11, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PPF ALLEGES ELEVATED METAL IONS. ADDED LAWYER, LAW FIRM AND REVISION HOSPITAL. UPDATED PART AND LOT NUMBERS OF THE IMPACTED PRODUCTS. DOI: (B)(6) 2008. DOR: (B)(6) 2017. (RIGHT HIP).

  Patient problems: Discomfort; Irritation; Pain

  MAUDE report 6855834 ↗
• InjurySep 1, 2017Corroded; Appropriate Device Problem Term/Code Not Available; Corroded; Appropriate Device Problem Term/Code Not Available

  NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - LITIGATION PAPERS ALLEGE THE PATIENT SUFFERS FROM PAIN, METALLOSIS, THE INABILITY TO WALK AND ELEVATED METAL ION LEVELS. DOI: (B)(6) 2009 (LEFT HIP). DOR: NO DATE SET AS OF YET. RESIDENT OF (B)(6). UPDATE 9/19/12 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION AND CORRECT DATE OF IMPLANT. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DOI: (B)(6) 2009. UPDATE 07 APRIL 2014 DER RECEIVED HOSPITAL (B)(4). DOR (B)(6) 2014. ADDITIONAL PRODUCT ADDED - TAPER SLEEVE. UPDATE AUG 4, 2017: MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR THE MDR REPORTABILITY, PATIENT WAS REVISED TO ADDRESS PAINFUL PROSTHESIS AND RISING ELEVATED METAL LEVELS. REVISION NOTES REPORTED GRAYISH BROWNISH TYPE FLUID SHOOTING OUT UNDER PRESSURE (WATER-FOUNTAIN EFFECT) ASSOCIATED WITH METAL ON METAL REACTION, AND TREMENDOUS AMOUNT OF BURNISHING AROUND THE TRUNNION. ADDED STEM TO THE COMPLAINT DUE TO ELEVATED METAL IONS. THERE WERE NO LABORATORY RESULTS PROVI

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Pain

  MAUDE report 6837844 ↗
• InjuryJun 23, 2017Loss of Osseointegration; Loss of Osseointegration

  DER STATED THAT THE PATIENT HAD 2 DISLOCATIONS AND CAME INTO THE ER AT (B)(6) AND WAS SEEN BY A SURGEON. X-RAYS SHOWED THAT THE FEMORAL STEM HAD SPUN OUT OR CAME LOOSE IN THE FEMUR WHICH MADE THE JOINT UNSTABLE. THE PATIENT WAS REVISED ON (B)(6) 2017 WHERE THE FEMORAL STEM AND HIP BALL WAS REMOVED AND A NEW STEM WAS INSERTED WITH GOOD FIXATION AND THE JOINT WAS STABLE. SURGEON STATED THE STEM HAD CAME LOOSE AND THE HIP DISLOCATED AS A RESULT.

  Patient problems: No Information

  MAUDE report 6664935 ↗
• InjuryJan 28, 2014Corroded

  PATIENT WAS REVISED TO ADDRESS TROCHANTERIC BURSA COLLECTION. IT WAS ALSO REPORTED THAT CORROSION WAS FOUND ON THE NECK OF THE FEMORAL STEM.

  Patient problems: Host-Tissue Reaction; No Information

  MAUDE report 3594913 ↗