ARTICUL/EZE 4734-40-920Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295505747), received between Oct 2, 2024 and Sep 18, 2026 — classified as 10 injuries, 2 malfunctions.

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Device Dislodged or Dislocated

  Patient problems: Joint Dislocation

  MAUDE report 50827653 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 50816310 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient had potential infection, so surgeon removed old liner and head ball.DOI: (b)(6) 2026,DOR: (b)(6) 2026,Affected Side: Unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50036184 ↗
• MalfunctionMar 4, 2026Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT WHILE FEMORAL HEAD WAS BEING OPENED ONTO THE FIELD, THE STERILE SEAL TORE LEAVING BEHIND FIBERS OF PAPER. THE IMPLANT WAS CONSIDERED CONTAMINATED AND ANOTHER ONE WAS OPENED TO COMPLETE SURGERY. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24513917 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. HEAD LINER EXCHANGE WAS PREFORMED DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24012595 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AS PATIENT WAS THOUGHT TO BE INFECTED. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23976419 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED RIGHT TOTAL HIP. THE SURGEON DID A WASHOUT WITH HEAD AND LINER EXCHANGE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22962098 ↗
• MalfunctionJul 28, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT SURGEON ATTEMPTED TO IMPLANT THE NEW CERAMIC 40 HEAD SIZE MINUS 2. THE SURGEON COULD NOT GET THE HEAD TO STICK ON THE TRUNION OF THE ACTIS STEM. SURGEON TRIED MULTIPLE TIMES WITH VARYING DEGREES OF STRIKING PRESSURE. SURGEON ENDED UP IMPLANTING A SIZE40 +1.5 HEAD AND IT STUCK FINE. HIP WAS STABLE. FEMORAL HEAD WAS LOOSE. LOOSENING INTERFACE IS NOT APPLICABLE AND CEMENT MANUFACTURER IS UNKNOWN. DOE: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22630620 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED AS PER SURGEON. SURGEON KEPT INITIAL IMPLANTS AND DID A POLY AND HEAD EXCHANGE. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22469872 ↗
• InjuryJun 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. SURGEON CHANGED LINER (NON-DEPUY) AND PERFORMED HEAD SWAP (JNJMT) AS A DIFFERENT HEAD SIZE WAS REQUIRED FOR THE NEW LINER. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22183852 ↗
• InjuryFeb 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. POST SURGERY, PATIENT FELL AND DISLOCATED THE HIP. SINCE THE ORIGINAL FALL, THE PATIENT HAS HAD OTHER DISLOCATIONS, WHICH REQUIRED HIS HIP TO BE REVISED. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 21354031 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO ACUTE HIP PAIN. SURGEON ELECTED TO PERFORM AN I&D AND DEBRIDEMENT TO TREAT FOR A POSSIBLE INFECTION OF THE RIGHT HIP. SURGEON TOOK TISSUE SAMPLE TO BE TESTED. AT THE END OF PROCEDURE SURGEON REMOVED THE TWO SCREWS, LINER, AND HEAD FROM THE INDEX SURGERY LEAVING THE CUP AND STEM. HE IMPLANTED A NEW LINER INTO THE INDEX CUP AND ELECTED TO IMPLANT ANOTHER CERAMIC HEAD BEFORE REDUCING THE JOINT AND CLOSING. NO INSTRUMENTS BROKER DURING SURGERY. THERE WERE NO DELAYS. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 20355264 ↗