ARTICUL/EZE 4734-40-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295505761), received between Jun 7, 2025 and Sep 28, 2026 — classified as 22 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised due to pain.Affected Side: Left Hip.

  Patient problems: Pain

  MAUDE report 50920223 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50829007 ↗
• InjurySep 10, 2026Device Dislodged or Dislocated

  It was reported that the patient underwent the second revision for dislocating hip. This time they went with dual mobility with a bigger head.DOI: Unknown .DOR: (b)(6) 2026.Affected side: Left hip.

  Patient problems: Joint Dislocation

  MAUDE report 50716419 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50572918 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised due to Pain.DOI: (b)(6) 2026,DOR: (b)(6) 2026,Affected side: Right.

  Patient problems: Pain

  MAUDE report 50524517 ↗
• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  Subject ID: (b)(6).Study No: (b)(4).Clinical Adverse Event received for Revision ¿ InfectionDevice related: No information providedProcedure related: No information providedDate of Event: 27 Apr 2026Date of Implant: (b)(6) 2026Date of Revision: (b)(6) 2026Device Location: RightTreatment/Impact: DePuy Synthes components were removed (head and liner).

  Patient problems: Unspecified Infection

  MAUDE report 50326669 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50155418 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was being revised due to an infection. This was I&D, head and liner swap. The liner was removed and replaced with a new liner of the same size. The head was also removed and replaced with a revision ceramic head of the same size.DOI- (b)(6) 2026.DOR- (b)(6) 2026.Affected side- Left Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50143835 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS INFECTED. SURGEON WASHED JOINT OUT AND CHANGED HEAD AND LINER. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25677078 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S HIP IS INFECTED. HEAD AND LINER WERE EXCHANGED AND JOINT WAS WASHED OUT. ANTIBIOTICS PLACED. THERE WAS NO PATIENT INJURY OR DELAY. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24971293 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMES IN TODAY WITH A PERI PROSTHETIC FRACTURE. DR REMOVED THE POLY, STEM AND HEAD SINCE THEY WERE LOOSE AND WENT BACK IN WITH A RECLAIM MONOBLOCK STEM. NO FURTHER PATIENT INFORMATION WAS AVAILABLE AT THIS TIME. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 24909462 ↗
• InjuryApr 9, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS DISLOCATING. AN ELEVATED RIM LINER WAS PLACED. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 24831715 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO CONTINUED INFECTION. IT WAS STATED THAT COMPETITOR'S CUP WAS LOOSE AT BONE TO CEMENT. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24690577 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION, THEREFORE AN I&D WITH HEAD BALL AND LINER EXCHANGE WAS PERFORMED. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24059736 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. IMPLANTS WERE EXTRACTED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23908864 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 23803917 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. SURGEON REMOVED THE LINER AND HEAD FOR A WASHOUT. NEW LINER AND HEAD IMPLANT WAS THEN IMPLANTED INTO THE PATIENT. DOI: UNKNOWN DATE, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23073875 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT STARTED HAVING REDNESS AROUND THE INCISION. DETERMINED THAT IT COULD BE INFECTED RESULTING IN AND I&D. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 22915230 ↗
• InjuryAug 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS DISLOCATING BECAUSE OF A STIFF SPINE AND SPINAL HARDWARE ALL THE WAY UP. SURGEON REVISED THE CUP AND CHANGED THE VERSION AND INCLINATION ON THE CUP. NO TIME ADDED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Muscular Rigidity

  MAUDE report 22715850 ↗
• InjuryJul 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 FOR INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22594810 ↗
• InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A FALL POST-OPERATIVELY AND DEVELOPED AN UNSTABLE HIP CONSTRUCT. SURGERY PERFORMED TO SWITCH LINER/HEAD TO DUAL MOBILITY AND ADD LEG LENGTH TO ADD STABILITY. DOI: (B)(6) 2025. DOE: (B)(6) 2025. AFFECTED SIDE: RGHT HIP.

  Patient problems: Fall; Joint Laxity

  MAUDE report 22457824 ↗
• InjuryJun 18, 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 OF HIP. POLY AND HEAD WERE EXCHANGED. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22284246 ↗
• MalfunctionJun 7, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED A 40+5 HEAD WAS IMPACTED WITH THE KINCISE AND THEN IT ¿POPPED OFF¿. SURGEON THEN SWITCHED TO A TS CERAMIC. AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22162870 ↗