ARTICUL/EZE 1365-11-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 262 adverse event reports that list this exact device (DI 10603295033066), received between Jul 9, 2013 and Sep 18, 2026 — classified as 1 death, 254 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (66 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 262 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Device Dislodged or Dislocated

  It was reported that the poly exchange due to anterior dislocation.Affected side: Right Hip.

  Patient problems: Joint Dislocation

  MAUDE report 50820579 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Patient was revised for infected bipolar hip. Head was exchanged.DOI: Unknown.DOR:(b)(6) 2026.Affected Side: Unknown Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50756070 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient showed signs of infection. Doctor performed an I&D and swapped out the heads for new ones.DOI: Unknown.DOR: (b)(6)2026.Affected Side: Right.

  Patient problems: Unspecified Infection

  MAUDE report 50548014 ↗
• InjuryAug 31, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50521570 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Bipolar head removed for washout of Right Hip. Surgeon replaced 45 bipolar head and 28+1.5 articuleze head. Bipolar head swapped out as because of potential infected hip. There was no patient complaints.Affected Side: Right Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50068602 ↗
• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT SHOWED SIGNS OF INFECTION. DOCTOR DECIDED TO WASHOUT THE HIP AND REPLACE THE BIPOLAR AND 28 HEADS. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25599806 ↗
• MalfunctionJun 5, 2026Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THERE WAS A PACKAGING ISSUE WHEN THE IMPLANT WAS BEING OPENED AND PUT ONTO THE STERILE FIELD. WHEN THE CIRCULATOR ATTEMPTED TO OPEN THE OUTER BLISTER OF THE IMPLANT BOX, THE TOP PORTION PEELED OFF, BUT IT DID NOT PEEL OFF CLEANLY AND IT WAS RIPPING. THIS REQUIRED THE CIRCULATOR TO PULL OUT THE IMPLANT AND ATTEMPT TO OPEN IT ONTO THE FIELD, BUT THEN THE INNER BLISTER STARTED RIPPING WHEN THE PACKAGE WAS BEING OPENED.

  Patient problems: Insufficient Information

  MAUDE report 25414305 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A HIP INFECTION. SURGEON WASHED THE HIP OUT AND REPLACED THE HEAD BALL COMPONENTS OF THE HEMI HIP. INFECTION WAS PRESENT. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25052531 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REMOVED COMPONENTS DUE TO FX, DISLOCATION, AND NON COMPLIANCE. DOI- (B)(6) 2026. DOR- UNKNOWN. AFFECTED SIDE-RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 24915411 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED RIGHT HIP. BIPOLAR HEAD AND 28 HEAD EXCHANGE. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24473056 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 24257679 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ARTIFICIAL BONE REPLACEMENT SURGERY ON HIP JOINT WITH THE PRODUCTS IN QUESTION. AFTER THE SURGERY, THE INFECTION WAS SUSPECTED. THE DEBRIDEMENT WAS PERFORMED ON (B)(6) 2026, BUT THE INFECTION NUMBERS DID NOT IMPROVE. NO FURTHER INFORMATION IS AVAILABLE. THIS PC IS RELATED TO (B)(4) WHICH REPORTS THE REMOVAL SURGERY. THIS PC REPORTS THE DEBRIDEMENT PERFORMED ON (B)(6) 2026.

  Patient problems: Unspecified Infection

  MAUDE report 24235629 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Laxity

  MAUDE report 24215876 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PRIMARY SURGERY WAS PERFORMED ON (B)(6), 2025. AFTER THE SURGERY, THE INFECTION WAS SUSPECTED. THE DEBRIDEMENT WAS PERFORMED ON (B)(6) 2026, (REPORTED ON PC (B)(4)) BUT THE INFECTION NUMBERS DID NOT IMPROVE. THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2026, DURING THE SURGERY, THE STEM WAS FIXED AND ONLY THE ACETABULAR SIDE WAS REMOVED. THE CEMENT MOLD WAS PLACED AND THE SURGERY WAS COMPLETED.

  Patient problems: Unspecified Infection

  MAUDE report 24211666 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS WERE REPLACED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24189664 ↗
• MalfunctionJan 15, 2026Difficult to Insert

  IT WAS REPORTED THAT SURGEON HAD ISSUES GETTING LINER TO BE SEATED INTO THE HEAD. CAUSED SOME POLY WEAR. OPTED FOR NEW COMPONENTS. THERE WAS A DELAY OF LESS THAN TWO MINUTES. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24080401 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR IRRIGATION AND DEBRIDEMENT WITH HEAD EXCHANGE DUE TO INFECTION. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24009964 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS QUITE SICK AND HAS SOME INCISIONAL DRAINAGE THAT THE SURGEON DIDN'T LIKE. HE ELECTED TO WASHOUT AND CHANGE MODULAR COMPONENTS. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fluid Discharge

  MAUDE report 23887803 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23685786 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23679512 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE REASON FOR THE REVISION SURGERY WAS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23535192 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FIRST STAGE INFECTION. SURGEON WASHED OUT AND SWAP THE BIPOLAR HEAD. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23378278 ↗
• InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD UNSTABLE HIP, SO WE ADDED SOME LENGTH TO INCREASE STABILITY. NOTHING WRONG WITH IMPLANTS AND NO ADVERSE SITUATION CORRESPONDING TO IMPLANTS. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: BOTH HIP.

  Patient problems: Joint Laxity

  MAUDE report 23338010 ↗
• InjuryOct 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE WAS DISLOCATION OF HIP. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23290879 ↗
• InjurySep 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS PROCEDURE WAS THE FIFTH PROCEDURE ON THIS PATIENT'S RIGHT HIP. SHE INITIALLY FRACTURED HER HIP FOR WHICH BIPOLAR COMPONENTS WERE USED TO REPAIR HER HIP. SHE THEN UNDERWENT A SECOND PROCEDURE THREE MONTHS LATER TO CONVERT HER BIPOLAR HIP TO A TOTAL HIP DUE TO DISLOCATIONS AND INSTABILITY. DURING HER THIRD PROCEDURE, THE PATIENT'S ACETABULAR LINER AND FEMORAL HEAD WERE SWAPPED OUT FOR A CONSTRAINED ACETABULAR LINER AND HEAD DUE TO CONTINUED DISLOCATIONS. DURING HER FOURTH PROCEDURE, HER CONSTRAINED ACETABULAR LINER AND FEMORAL HEAD WERE SWAPPED OUT A SECOND TIME DUE TO DISLOCATION. HER HIP HAD DISLOCATED EVEN THOUGH THE CONSTRAINED LINER LOCKING RING WAS STILL IN PLACE. DURING THE PATIENT'S FOURTH PROCEDURE, DOCTOR WAS UNABLE TO FULLY SEAT THE LOCKING RING FOR THE FIRST CONSTRAINED LINER HE IMPLANTED. HE THEN SWAPPED IT OUT FOR A SECOND CONSTRAINED LINER, SINCE HE HAD DAMAGED THE POLYETHYLENE PORTION OF THE FIRST LINER WHILE ATTEMPTING TO SEAT THE LOCKING RING. UNFORTUNATELY, HE WAS ALSO UNSUCCESSFUL IN HIS ATTEMPTS TO FULLY SEAT THE SECOND LOCKING RING INTO THE SECOND LINER. AFTER NUMEROUS ATTEMPTS TO SEAT THE LOCKING RING, HE LEFT THE SECOND LINER IN PLACE

  Patient problems: Joint Dislocation

  MAUDE report 23073003 ↗