ARTICUL/EZE 1365-54-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 141 adverse event reports that list this exact device (DI 10603295033974), received between Jan 18, 2013 and Jun 29, 2026 — classified as 138 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (33 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 141 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 25652567 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD MOM HIP IMPLANTED (B)(6) 2009. PATIENT WAS REVISED TO POLY ON CERAMIC FEMORAL HEAD. PATIENT HAD PAIN, HIGH ALVAL SCORE AND BONE LOSS. DOI: (B)(6) 2009. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Bone Notching; Foreign Body Reaction; Pain

  MAUDE report 24752663 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ASR WAS REVISED DUE TO METALLOSIS AND ELEVATED CHROMIUM LEVELS. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 24083315 ↗
• InjurySep 10, 2025Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LINER DISASSOCIATED WITH THE CUP. SEVERE METALOSIS. DOI: (B)(6) 2012. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 23015490 ↗
• InjuryMay 9, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THE PATIENT WAS REVIEWED; THE MOM LINE, HEAD, ONE SCREW AND A HOLE ELIMINATOR WERE REMOVED. IT WAS NOTED THE IMPLANTS WERE COATED WITH A GREY/BLACK DEBRIS AND THE JOINT FLUID WAS SLIGHTLY GREYISH. THE RETAINED CUP AND STEM WERE CLEANED, AND A NEW LINER AND HEAD WERE IMPLANTED. GENX BONE FILLER WAS INJECTED IN THE REMOVED SCREW SPACE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Bone Notching; Fibrosis; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Metal Related Pathology; Pain; Swelling/ Edema

  MAUDE report 21994497 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ALL PARTS WERE REMOVED DUE TO INFECTION OF THE HIP JOINT. THERE WAS STEM LOOSENING FROM INFECTION AT THE NON-CEMENTED INTERFACE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21924952 ↗
• InjuryApr 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A DISLOCATION 3 MONTHS BEFORE (B)(6) 2023. THE REVISION SURGERY IS SCHEDULED ON (B)(6) 2023, DUE TO THE DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 16681443 ↗
• InjuryApr 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2009, THE PRIMARY SURGERY WAS PERFORMED VIA THA WITH THE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE PATIENT HAD A DISLOCATION 3 MONTHS BEFORE (B)(6) 2023. THE REVISION SURGERY IS SCHEDULED ON (B)(6) 2023, DUE TO THE DISLOCATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 16681231 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO DROP FOOT / NERVE IMPINGEMENT. THERE WAS NO SURGICAL DELAY. DOI: ON (B)(6) 2023, DOR: ON (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Nerve Damage

  MAUDE report 16373893 ↗
• InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 16051198 ↗
• InjuryOct 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION AND LOOSENING OF THE LOCKING RING. DOI: (B)(6) 2015. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 15551318 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS ADMITTED TO HOSPITAL FOR INFLAMMATION. SURGERY WAS PERFORMED TO REMOVE METAL ON METAL IMPLANTS, LINER AND HEAD ONLY WAS REMOVED. BONE LOST ON PROXIMAL FEMUR.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Unspecified Tissue Injury

  MAUDE report 15528143 ↗
• InjurySep 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR PE AND SEPSIS. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (LEFT KNEE). TREATMENT: UNSPECIFIED INJECTED MEDICATION

  Patient problems: Pulmonary Embolism; Sepsis

  MAUDE report 15494132 ↗
• InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION SO THE DOCTOR DID A ONE STAGE REIMPLANTATION WITH NEW COMPONENTS AFTER A COMPLETE WASHOUT. NO SURGICAL DELAY. THERE WAS LOOSENING AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2019; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15241273 ↗
• InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PC WAS CREATED TO CAPTURE FOR LEFT HIP. ELEVATED METAL IONS REPORTED AT RIGHT HIP. PATIENT HAD A BILATERAL HIP ARTHROPLASTY SURGERY. PINNACLE MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS THERE WERE NO REVISION NOTES REPORTED. DOI: 2013, DOR: UNKNOWN, LEFT HIP.

  Patient problems: Metal Related Pathology

  MAUDE report 15216430 ↗
• InjuryJun 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO DUAL MOBILITY DUE TO DISLOCATION. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 14842572 ↗
• InjuryJun 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEAD AND LINER CHANGE DUE TO INFECTION. IMPLANT DATE (B)(6) 2022. EXPLANT DATE (B)(6) 2022.

  Patient problems: Unspecified Infection

  MAUDE report 14787882 ↗
• InjuryJun 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INITIAL IMPLANT ON DATE (B)(6) 2022. MOBILIZATION OF THE PROSTHESIS AFTER IMPLANTATION: IN ADDITION METALLOSIS: MOLYBDENUM 3.8 UG/L, CR 66 UG/L; CO 95.5 UG/L, AL 7.85 UG/L. NEEDED REVISION SURGERY THAT TOOK PLACE AT CASA DI CURA VILLA BIANCO IN TRENTO DUE TO MECHANICAL LOOSENING OF THE JOINT PROSTHESIS.

  Patient problems: Foreign Body Reaction; Joint Laxity; Metal Related Pathology

  MAUDE report 14787500 ↗
• InjuryJun 16, 2022Degraded; Naturally Worn; Degraded; Naturally Worn

  IT WAS REPORTED BY THE PATIENT "I HAD A HIP REPLACEMENT IN 2014 THAT FAILED EARLIER THIS YEAR. I AM TRYING TO FIND OUT IF THE PARTS THAT WERE USED WERE RECALLED OR SHOULD HAVE NOT BEEN USED IN COMBINATION. THE PART WAS DEPUY SUMMIT WITH A COMPETITOR TITANIUM CUP AND COBALT CHROME ON POLYETHYLENE ARTICULATION." DOI: 2014 : DOR: NONE REPORTED . AFFECTED SIDE: UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Inflammation; Metal Related Pathology; Muscle/Tendon Damage; Necrosis

  MAUDE report 14713453 ↗
• InjuryMay 13, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO BILATERALLY METAL ON METAL BEARING BC OF RISING METAL LEVELS AND POSSIBLE PSEUDOTUMOR SEEN ON MRI. THE LEFT SIDE WAS REVISED FIRST; HEAD WAS DISLODGED WITHOUT INCIDENT AND THEN THE METAL LINER WAS DISLODGED WITHOUT INCIDENT. A HOLE ELIMINATOR, 36X58NEUTRAL POLY LINER, AND 36+12 CERAMIC HEAD WERE IMPLANTED. THE RIGHT WAS REVISED SECOND;HEAD WAS DISLODGED WITHOUT INCIDENT AND THEN THE METAL LINER WAS DISLODGED WITHOUT INCIDENT. A HOLE ELIMINATOR, 36X58NEUTRAL POLY LINER, AND 36+12 CERAMIC HEAD WERE IMPLANTED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hypersensitivity/Allergic reaction; Joint Dislocation

  MAUDE report 14395618 ↗
• InjuryMay 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO BILATERALLY METAL ON METAL BEARING BC OF RISING METAL LEVELS AND POSSIBLE PSEUDOTUMOR SEEN ON MRI. THE LEFT SIDE WAS REVISED FIRST; HEAD WAS DISLODGED WITHOUT INCIDENT AND THEN THE METAL LINER WAS DISLODGED WITHOUT INCIDENT. A HOLE ELIMINATOR, 36X58 NEUTRAL POLY LINER, AND 36+12 CERAMIC HEAD WERE IMPLANTED. THE RIGHT WAS REVISED SECOND;HEAD WAS DISLODGED WITHOUT INCIDENT AND THEN THE METAL LINER WAS DISLODGED WITHOUT INCIDENT. A HOLE ELIMINATOR, 36X58NEUTRAL POLY LINER, AND 36+12 CERAMIC HEAD WERE IMPLANTED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hypersensitivity/Allergic reaction; Joint Dislocation

  MAUDE report 14372899 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 13860387 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOI: (B)(6) 2004: PATIENT RECEIVED A PRIMARY LEFT THA TO TREAT ADVANCED AVASCULAR NECROSIS. THE PATIENT RECEIVED A PINNACLE/CORAIL METAL-ON-METAL HIP. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOR: (B)(6) 2019: PATIENT RECEIVED A LEFT HIP REVISION TO TREAT DULL PAIN AND MRI IDENTIFIED METAL-ON METAL REACTION. PREOPERATIVE TESTING REVEALED ELEVATED SERUM BLOOD HEAVY METAL LEVELS. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND EXCISED BLACK STAINED SYNOVIUM. THERE WAS NO WEAR OR REPORTED DEFECTS OF THE REVISED FEMORAL HEAD. THERE WAS MINIMAL CORROSION OF THE FEMORAL STEM TRUNNION. THE CORROSION WAS CLEANED, AND THE WELL-FIXED STEM WAS RETAINED. THERE WAS NOTED CORROSION ON THE METAL LINER, AND IT WAS REVISED. THE WELL-FIXED CUP WAS RETAINED. THE PATIENT WAS REVISED WITH A DEPUY POLY LINER AND CERAMIC FEMORAL HEAD. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2004. DOR: (B)(6) 2019. LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Pain

  MAUDE report 13802500 ↗
• InjuryFeb 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO LEFT HIP PAIN AND HIP JOINT INSTABILITY. HEAD WAS EXTRACTED AND A DUAL MOBILITY WAS PLACED USING A DEPUY 28 HEAD AND A STRYKER DUAL MOBILITY LINER TO MATCH THE STRYKER CUP. THE STEM WAS WELL FIXED AND WE BELIEVE IT WAS A DEPUY STABILITY HIP STEM. NO ADDITIONAL INFO. DOI: UNK. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT SIDE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 13568110 ↗
• InjuryFeb 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS HIP REVISION DUE TO LEFT HIP PAIN AND HIP JOINT INSTABILITY. HEAD WAS EXTRACTED AND A DUAL MOBILITY WAS PLACED USING A DEPUY 28 HEAD AND A STRYKER DUAL MOBILITY LINER TO MATCH THE STRYKER CUP. THE STEM WAS WELL FIXED AND WE BELIEVE IT WAS A DEPUY STABILITY HIP STEM. NO ADDITIONAL INFORMATION. DOI: UNKNOWN, DOR: FEB 8, 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity; Pain

  MAUDE report 13568104 ↗