CORAIL 3L93715Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295168928), received between Sep 17, 2018 and Mar 6, 2026 — classified as 18 injuries, 1 malfunction.

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

• InjuryMar 6, 2026Osseointegration Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO AN INFECTED HIP. ALL PRODUCTS WERE REMOVED FOR A SPACER. NO HARM WAS DONE ALL PIECE WERE REMOVED. LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 24531905 ↗
• InjuryJan 19, 2024Fracture; Fracture

  PROCEDURE: REVISION BROKEN NECK CORAIL STEM. DESCRIPTION OF ISSUE: BROKEN NECK CORAIL STEM (MAAT 15 KLA). WHEN DID THE EVEN OCCUR (PRE-OP/INTRA-OP/POST-OP)? POST OPERATIVE. WAS THERE ANY PATIENT CONSEQUENCE? REVISION SURGERY. WHAT ACTION WAS TAKEN TO RESOLVE THE ISSUE? REVISION OF STEM (CORAIL STEM). HOW LONG WAS THE PROCEDURE PROLONGED AS A RESULT OF THE DIFFICULTIES ENCOUNTERED WITH THE DEVICE (MINUTES)?

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18541796 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2015. DATE OF REVISION: (B)(6) 2023. (RIGHT HIP). TREATMENT: REVISION; STEM, HEAD, LINER, AND CUP WERE REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 16610192 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO MISMANAGED EARLY ON-SET INFECTION OF HIP. DOI: (B)(6) 2020; DOR: (B)(6) 2022 (LEFT HIP).

  Patient problems: Unspecified Infection

  MAUDE report 13498988 ↗
• InjuryJan 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE THA SURGERY FOR OA WITH THE STEM IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, AT THE MEDICAL EXAMINATION IN MAY, THE PATIENT SAID THAT THE AFFECTED AREA FELT STRANGE, BUT THERE WAS NO ABNORMALITY ON THE IMAGES. THE PATIENT WAS REVISED ON (B)(6) 2021. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 13235563 ↗
• InjuryNov 4, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT HEAD, LINER AND STEM WERE REMOVED FROM PATIENTS. IT WAS ALSO INDICATED THAT THE STEM WAS LOOSED AT THE BONE TO IMPLANT INTERFACE. NO SURGICAL DELAY. DOI: (B)(6) 2014. DOR: (B)(6) 2021. AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12751376 ↗
• InjuryOct 5, 2021Degraded; Degraded

  MEDICAL RECORD RECEIVED. AFTER REVIEW OF MEDICAL RECORD PATIENT WAS REVISED TO ADDRESS METALLOSIS. REVISION NOTES STATED THAT HEAD WAS REMOVED WITH EVIDENCED OF CORROSION. SOFT TISSUE AT THE PERIPHERY OF THE ACETABULAR COMPONENT WAS REMOVED, AFTER WHICH THE CURVED ACETABULAR OSTEOTOMES WERE USED TO REMOVE THE ACETABULAR COMPONENT WITH MINIMAL BONE LOSS. THERE WAS A CONTAINED DEFECT IN THE ISCHIUM WHICH DID NOT INVOLVE THE CORTEX. THE GREATED TROCHANTER HAD SOME OSTEOLYSIS SECONDARY TO METAL DEBRIS BUT WAS INTACT. LIMB LENGTHS WERE IMPROVED FROM THE 9 MM SHORT THAT THE PATIENT WAS BEFORE. DOI: (B)(6) 2008 . DOR: (B)(6) 2020. (RIGHT HIP).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Osteolysis; Physical Asymmetry; Unspecified Tissue Injury

  MAUDE report 12576496 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS REPORTED THAT THE PATIENT HAD A DRAINING OF SURGICAL WOUND PROCEDURE WITH EXTENSIVE SOFT TISSUE NECROSIS SECONDARY TO METALLOSIS FROM PREVIOUS EXPLANTED METAL ON METAL THA. OPERATIVE NOTE REPORTED THAT, UPON ENTERING THE WOUND THERE WAS NOTED TO BE EXTENSIVE SOFT TISSUE NECROSIS WITH A INCOMPLETE FASCIA LAYER. SOME OF THE NECROSIS EXTENDED INTO THE SUBCUTANEOUS TISSUES. THE PROXIMAL VASTUS LATERALIS WAS IDENTIFIED, THIS TOO APPEARED NECROTIC. DOI: (B)(6) 2007 (CUP, SCREW, STEM), DOI: (B)(6) 2021 (HEAD, LINER), DOE: (B)(6) 2021, RIGHT HIP.

  Patient problems: Fluid Discharge; Foreign Body Reaction; Unspecified Tissue Injury

  MAUDE report 12089153 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS REPORTED THAT THE PATIENT FELL SUSTAINING THE AFOREMENTIONED PERIPROSTHETIC HIP FRACTURE. PATIENT ALSO HAD 3 PREVIOUS DISLOCATION EVENT. THE PATIENT WAS THEN REVISED FOR RIGHT PERIPROSTHETIC PROXIMAL FEMUR FRACTURE AND METAL ON METAL THA COMPONENTS WITH EXTENSIVE METALLOSIS AND SOFT TISSUE NECROSIS. OPERATIVE NOTES INDICATE THAT A EXTENSIVE HEMATOMA WAS ENCOUNTER. IT WAS NOTED THAT NO FASCIA PRESENT AS THERE WAS A DIRECT LINE FROM THE HEMATOMA INTO THE JOINT HIP. IT APPEARED THAT THERE WAS EXTENSIVE METALLOSIS AND SOFT TISSUE NECROSIS LIKELY RELATED TO THE METAL ON METAL ARTICULATION. THE POSTERIOR ASPECT OF THE GREATER TROCHANTER WAS NOTED TO BE DENUDED OF THE SOFT TISSUE ATTACHMENT. IT WAS INDICATED THAT STEM WAS STABLE AND ONLY THE GREATER TROCHANTER WAS FRACTURED AND FRAGMENTED. THERE WAS NOTED TO BE SOME METALLOSIS ALONG THE TRUNNION. DOI: (B)(6) 2007. DOR: (B)(6) 2021. RIGHT HIP.

  Patient problems: Fall; Foreign Body Reaction; Hematoma; Limb Fracture; Unspecified Tissue Injury

  MAUDE report 12089015 ↗
• InjuryApr 15, 2020Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  REVISION HIP (L) - STEM REVISED; (B)(6) HOSPITAL, (B)(6) 2020 - PATIENT PRESENTED WITH PAIN, X-RAY TAKEN SHOWING THE IMPLANT HAD FRACTURED. STEM, HEAD AND LINER REVISED. JNJ REPRESENTATIVE WAS PRESENT FOR THE CASE; SURGEON COMMENTED THAT PATIENT WALKED DOWN THE STAIRS AND FELT A CLUNK, PATIENT DID NOT FALL.

  Patient problems: No Code Available; Pain

  MAUDE report 9963461 ↗
• InjuryFeb 28, 2020Degraded; Degraded

  PINNACLE MOM LITIGATION RECORDS RECEIVED ALLEGING INJURY, TISSUE DAMAGE, INFLAMMATORY ACTION, BONE LOSS, NECROSIS, GIGANTIC PSEUDOTUMOROUS REACTION, OSTEOLYSIS, CONSTANT PAIN AND SUFFERING AND LOSS OF MOBILITY IN THE RIGHT LEG AND HIP. UPDATE AD 28 AUG 2019: AFTER REVIEW OF MEDICAL RECORDS, IT WAS INDICATED THAT THE PATIENT HAD PAIN AND BONE LOSS. X-RAY RESULTS MARK OSTEOLYSIS. THE PATIENT WAS THEN REVISED FOR FAILED LEFT TOTAL HIP REPLACEMENT SECONDARY TO METAL-METAL DISEASE. OPERATIVE NOTES REPORTED THAT THERE WERE CORROSIVE CHANGES AT THE NECK AND HEAD JUNCTION, AS WELL AS A PSUEDOTUMOR REACTION OR CORROSION CHANGES, AT THE JUNCTION OF LINER AND SHELL. THERE WAS A SIGNIFICANT AMOUNT OF PSEUDOTUMOR IN THE AREA OF LYSIS. DOI: (B)(6) 2007; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Extraskeletal ossification; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Injury; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; Metal Related Pathology; Necrosis; No Code Available; Osteolysis; Pain; Tissue Damage; Unspecified Tissue Injury

  MAUDE report 9771270 ↗
• MalfunctionFeb 12, 2020Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging

  PART #3L93715, LOT #5348947 WAS RECEIVED ON ORDER #(B)(4) AT A HOSPITAL WITH WATER DAMAGE. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9702306 ↗
• InjuryJan 15, 2020Naturally Worn; Naturally Worn

  COMPLAINT DESCRIPTION: PATIENT WAS REVISED DUE TO OSTEOLYSIS. SURGERY WAS DELAYED 10-15 MINUTES TO REMOVE METAL LINER. UPDATE AD 02 APR 2019: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS FAILED RIGHT HIP REPLACEMENT WITH METALLOSIS AND PSEUDOTUMOR. REVISION NOTE REPORTED METALLOSIS, CAPSULITIS, PSEUDOTUMOR, GRANULAR METAL WEAR DEBRIS AROUND THE PROXIMAL FEMUR AND INFERIOR ASPECT OF THE ACETABULUM, OSTEOLYSIS AND IT WAS ALSO MENTION THAT THERE WAS NO EVIDENCE OF LOOSENING. INDICATION NOTE REPORTED PAIN, X-RAYS SHOWED OSTEOLYSIS AROUND THE INFERIOR ASPECT OF THE CUP AND PROXIMAL FEMUR AND WEAR DEBRIS. ADDED STEM AND CUP DUE TO NEW ALLEGATION REPORTED FROM MEDICAL RECORDS. ADDED NEW PATIENT CODE MEDICAL DEVICE REMOVAL; AND PATIENT MEDICAL HISTORY AND UPDATED INITIALS. DOI: (B)(6) 2007. DOR: (B)(6) 2016, (RIGHT HIP) FIRST REVISION.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; No Code Available; Osteolysis; Pain; Tissue Damage

  MAUDE report 9591160 ↗
• InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO INFECTION. DOI: UNKNOWN; DOR: UNKNOWN; LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9342940 ↗
• InjurySep 17, 2019Inadequacy of Device Shape and/or Size; Fitting Problem; Loss of Osseointegration; Inadequacy of Device Shape and/or Size; Fitting Problem; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT HAD A HIP REPLACEMENT SURGERY ON (B)(6) 2019. HE WAS COMPLAINING OF SEVERE HIP PAIN, SO THE SURGEON HAD A HIP REVISION SURGERY. THE STEM WAS GROSSLY LOOSE. THE SURGEON SAID HE UNDERSIZED THE STEM WHEN HE IMPLANTED IT.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 9075165 ↗
• InjuryMar 6, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8396065 ↗
• InjuryJan 10, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENTS MOM CONSTRUCT WAS REVISED TO ADDRESS ACUTE INFECTION. STEM WAS ALSO FOUND TO BE LOOSE AT THE BONE TO IMPLANT INTERFACE. ALL COMPONENTS REMOVED AND REPLACED WITH CEMENT SPACER. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available; Unspecified Infection

  MAUDE report 8235293 ↗
• InjuryNov 15, 2018Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available; Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8074166 ↗
• InjurySep 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR POSSIBLE INFECTION. TREATED AS A ONE STAGE REVISION, WITH ALL COMPONENTS BEING REMOVED AND REPLACED. DOI: (B)(6) 2018; DOR: (B)(6) 2018; UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 7881717 ↗