ARTICUL/EZE 4734-40-085Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295505778), received between Sep 5, 2025 and Jan 28, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO DISLOCATION, WITH THE ORIGINAL STEM DESCRIBED AS UNDERSIZED AND ROTATED AFTER IMPLANTATION. DOI-(B)(6) 2025. DOR-(B)(6) 2026. AFFECTED SIDE-RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24203726 ↗
• InjuryDec 11, 2025Improper or Incorrect Procedure or Method; Noise, Audible; Improper or Incorrect Procedure or Method; Noise, Audible

  PATIENT WAS REPORTING "CLANKING" DURING POST OP PT. X-RAYS LOOKED IN ORDER ACCORDING TO THE SURGEON, SO THEIR ASSUMPTION WAS THAT THE LINER MAY NOT HAVE ENGAGED FULLY. PATIENT WAS TAKEN BACK TO SURGERY; STEM AND FEMORAL HEAD WERE EXPLANTED. THE CUP AND LINER WERE SOLID WITH NO VISIBLE ISSUE ACCORDING TO THE SURGEON. THE SURGEON DETERMINED THE STEM TO BE UNDERSIZED AND LOOSE AT NON-CEMENTED INTERFACE. FEMUR WAS REBROACHED UP TO A SIZE 7 ACTIS COLLARED; HAD GOOD AXIAL AND ROTATIONAL STABILITY. A +12MM TS HEAD WAS IMPACTED AND THE LEG WAS REDUCED. CONSTRUCT WAS STABLE, HAD GOOD SCHUCK, AND WAS NOT DISLOCATING/IMPINGING. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778902 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HEAD LINER EXCHANGE TO RULE OUT INFECTION. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23300946 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. ORIGINAL SURGERY HAD AN ACTIS STEM, EMPHASYS CUP, EMPHASYS LINER, AND 40 MM HEAD. ALL THESE PARTS WERE REMOVED BY THE DOCTOR IRRIGATED AND DERIDED THEN RE-PREPPED AND IMPLANTED AN ACTIS COLLARLESS SIZE 9 HIGH STEM, 58 MM EMPHASYS CUP, 40 MM 58 MM EMPHASYS, NEUTRAL LINER, AND A 40 MM +5 FEMORAL HEAD. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22982806 ↗