ARTICUL/EZE 1365-23-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 124 adverse event reports that list this exact device (DI 10603295033196), received between Jul 20, 2017 and Jul 28, 2026 — classified as 122 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (67 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 124 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Device Dislodged or Dislocated

  It was reported that patient was revised due to dislocation.Affected Side: Left.

  Patient problems: Joint Dislocation

  MAUDE report 50054472 ↗
• InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COMPONENTS WERE REMOVED AND REPLACED BECAUSE OF WOUND DRAINAGE. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fluid Discharge

  MAUDE report 24839419 ↗
• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO HEMATOMA AND SUSPECTED INFECTION IN THE HIP, DURING WHICH THE POLYETHYLENE LINER AND FEMORAL HEAD WERE REPLACED FOLLOWING IRRIGATION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 24099919 ↗
• InjuryJan 8, 2026Naturally Worn

  IT WAS REPORTED FOLLOWING A HIP REVISION SURGERY, DURING WHICH A THIN MEMBRANE-LIKE STRUCTURE WAS OBSERVED BETWEEN THE METAL COMPONENT AND THE PLASTIC LINER. THIS STRUCTURE WAS SUSPECTED TO HAVE DETACHED FROM THE SURFACE OF THE METAL COMPONENT, THOUGH INSPECTION REVEALED THE INNER SURFACE AND LOCKING MECHANISM OF THE METAL COMPONENT APPEARED INTACT, AND THE COMPONENT WAS NOT REPLACED. THE PATIENT UNDERWENT REVISION SURGERY DUE TO A PSEUDOTUMOR, AND RECOVERED WITHOUT COMPLICATIONS. THE PAIN SYMPTOMS AND NEED FOR REVISION WERE INTERPRETED AS UNRELATED TO THE MEMBRANE-LIKE CHANGE OBSERVED DURING THE PROCEDURE. THE ACETABULAR CUP WAS EXPLANTED AND DESTROYED, AND IS NOT AVAILABLE FOR RETURN. OTHER COMPONENTS INVOLVED IN THE PRIMARY SURGERY INCLUDED SUMMIT POR TAPER SZ3 STD OFF, ARTICUL/EZE BALL 32 +9 BL, AND ALTRX +4 10D 32IDX48OD, ALL OF WHICH WERE ALSO EXPLANTED AND DESTROYED.

  Patient problems: Medical Device Site Inflammation; Pain

  MAUDE report 24002287 ↗
• InjuryJan 5, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. AFFECTED SIDE-LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23961900 ↗
• InjuryDec 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT DISLOCATED POST OP. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23844332 ↗
• InjuryJul 3, 2025Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED STATES THAT DURING THE REVISION SURGERY, IT WAS DISCOVERED THAT THE LINER AND HEAD HAD BEEN WORN DOWN.

  Patient problems: Joint Dislocation

  MAUDE report 22395259 ↗
• InjuryApr 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DUE TO REOCCURRING DISLOCATION, THE HEAD/LINER WERE EXCHANGED FOR CONSTRAINED LINER AND HEAD. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21908162 ↗
• InjuryNov 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. SURGEON REPLACED PROSTALAC CUP WITH A COMPETITOR CONSTRAINED CUP. HEAD WAS ALSO REPLACED. NO TIME LOST. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 20591636 ↗
• InjuryApr 25, 2024Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: DISLOCATION. AT REVISION THERE WAS FRETTING ON THE FEMORAL STEM. THE ACETABULAR LINER HAD CRACKING ON THE RIM AND NECK IMPINGEMENT.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 19183690 ↗
• InjuryApr 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT KEPT DISLOCATING. EXCHANGED HEAD BALL AND DID A CONSTRAINED LINER. UNKNOWN SURGICAL DELAY. DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN

  Patient problems: Joint Dislocation

  MAUDE report 19013380 ↗
• MalfunctionFeb 13, 2024Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping

  PACKAGING MATERIAL A PACKAGE THAT WAS DIFFICULT TO OPEN AND BROKE IN THE OPENING PROCESS. THE PAPER ON THE IMPLANT BOX, ON TOP, WAS TORN AND THE IMPLANT COULD NOT BE KEPT STERILE DURING OPENING. THEY TRIED SEVERAL TIMES, BUT IT JUST TORE INTO MORE PIECES. NO DELAYS AFFECTING TIME OR PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18697078 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD WORN DOWN THE LOCKING MECHANISM ON THE CONSTRAINED LINER AND DISLOCATED. SURGEON ELECTED TO PLACE A DUAL MOBILITY CONSTRUCT. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6), 2014, DOR- DECEMBER 14, 2023. AFFECTED SIDE- LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 18367043 ↗
• InjuryDec 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT CONTINUED TO DISLOCATE AFTER CONSTRAINED WAS IMPLANTED. SURGEON SUSPECTS IT¿S BECAUSE OF THE SPINAL FUSION THE PATIENT HAS AND NEEDED TO CHANGE THE CUP OUT. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18363466 ↗
• InjuryDec 1, 2023Noise, Audible; Noise, Audible

  PATIENT OPERATED PRIMARY AT A PRIVATE HOSPITAL IN (B)(6) 2020. SYMPTOMS STARTED IN (B)(6) 2023 JARRING NOISE. PATIENT UNDERWENT A REVISION OF THE CUP/LINER ON (B)(6) 2023. HEAD WAS WORN THROUGH THE LINER, AND HEAD MOVED AGAINST THE CUP, A LOT OF METALLOSIS. SURGEON TOOK OUT THE CUP AND INSERTED ANOTHER CUP NOT FROM DEPUY SYNTHES. THERE WAS NO SURGICAL DELAY.

  Patient problems: Foreign Body Reaction

  MAUDE report 18246638 ↗
• InjuryOct 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL AND INFECTED HIP. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17923138 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A REVISION OF THE DURALOC CONSTRAINED LINER AND HEAD FOR INFECTION. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17610528 ↗
• InjuryAug 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION OF ACETABULUM LEFT HIP. THE HIP WAS DISLOCATING. CHANGED CUP POSITION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17594975 ↗
• InjuryJul 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 17361504 ↗
• InjuryJul 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT HIP REPLACEMENT ON (B)(6) 2023. PATIENT WAS REVISED WITH DISLOCATION AND IT WAS DETERMINED THAT A REVISION WAS NECESSARY. THE CUP WAS CONVERTED TO A DUAL MOBILITY HEAD AND LINER ON (B)(6) 2023 WITHOUT INCIDENT. THERE WAS NO LOOSENING AND NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17297458 ↗
• InjuryApr 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. THE SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 16833408 ↗
• InjuryApr 17, 2023Noise, Audible; Noise, Audible

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO. THIS WAS PLANNED REVISION SURGERY. B. WAS ALL THE REPORTED PRODUCTS REVISED? NO. THE CUP, LINER, AND HEAD WERE REVISED AND THE STEM WAS LEFT.

  Patient problems: Foreign Body Reaction

  MAUDE report 16750736 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED TRUNIONOSIS. TRUNION AND INSIDE OF HEAD HAD VISIBLE TRUNIONOSIS. METAL HEAD ON TRILOCK STEM. HEAD AND LINER EXCHANGE WITH TS CERAMIC HEAD. CHROMIUM LEVEL 2.4, COBALT LEVEL 4.6. NO PSEUDOTUMOR PRESENT, ACTIVITY LEVEL - YES.

  Patient problems: Foreign Body Reaction

  MAUDE report 16742227 ↗
• InjuryDec 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 15987482 ↗
• InjuryOct 22, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION COMPLETED DUE TO FAILED CONSTRAINED LINER. HEAD DISLOCATED FROM POLY LINER. SURGERY TIME EXTENDED DUE TO DIFFICULTY REMOVING LINER FROM CUP. THERE WAS A SURGICAL DELAY OF 30 MINUTES. DOI: (B)(6) 2016. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 15656260 ↗