EMPHASYS 4725-54-044Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295500889), received between Jul 18, 2025 and Sep 9, 2026 — classified as 6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented with infected total hip needing head and liner exchange.DOI: (b)(6), 2026DOR: (b)(6), 2026Affected side: Right Hip

  Patient problems: Unspecified Infection

  MAUDE report 50695416 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 50074507 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISED DUE TO INFECTION. LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24876464 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAD THEIR HIP REPLACED THIS PAST JULY AND RECENTLY HAD A FALL WHERE THE WOUND WAS TORN OPEN. THE PATIENT HAD AN I&D OF THE WOUND AND NO COMPONENTS WERE REMOVED AT THAT TIME. THE EXACT DATE OF THE I&D IS UNKNOWN. THE PATIENT FOLLOWED UP WITH THE DOCTOR AND THE DECISION WAS MADE TO DO A DEEP I&D OF THE JOINT AND REPLACE THE DUAL MOBILITY HEAD AND LINER. AFTER THE I&D WAS DONE, THE ASSEMBLY OF THE NEW HIP BALL AND LINER WAS DONE ON THE BACK TABLE WHERE THERE WAS A STRUGGLE WITH GETTING THE HIP BALL TO BREACH THE DUAL MOBILITY LINER. THE PHYSICIAN FEELS THE DUAL MOBILITY ASSEMBLY HANDLE DOESN'T PROVIDE ENOUGH LEVERAGE WHICH MAKE ASSEMBLY DIFFICULT FOR SMALL HANDS. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 23016347 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A SEROMA AND DOCTOR DECIDED TO PERFORM AN I&D AND SWAP THE LINERS AND HEAD. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Seroma

  MAUDE report 22677642 ↗
• InjuryJul 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE DISLOCATIONS. ALL IMPLANTS WERE REMOVED AND A RECLAIM MONOBLOC WAS IMPLANTED WITH A PIN REVISION DPX CUP. AFFECTED SIDE : LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22541467 ↗