EMPHASYS 4722-50-236Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295501213), received between Jul 14, 2025 and Jun 30, 2026 — classified as 8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS DISLOCATING. THE SURGEON REVISED TO DUAL MOBILITY. AFFECTED SIDE-LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 25667225 ↗
• InjuryJun 29, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE DOCTOR REMOVED ALL IMPLANTS EXCEPT FOR FEMORAL STEM AND REPLACED WITH BIGGER CUP AND LINER DUE TO DISLOCATION. DOI: ON (B)(6) 2026, DOR: ON (B)(6) 2026, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 25654610 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT SHOWING SIGNS OF INFECTION. HEAD/LINER EXCHANGE. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24802690 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS A PREEXISTING INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE-LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24365139 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS A PREEXISTING INFECTION. DOI-UNKNOWN. DOR-(B)(6) 2026. AFFECTED SIDE-LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24364755 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS I&D FOR INFECTION. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24053164 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAD HER HIP REPLACED BY THE SURGEON ON (B)(6) 2025 AT THE HOSPITAL. THE PATIENT DID WELL INITIALLY BUT BEGAN TO EXPERIENCE PAIN AND HAS DRAINAGE COMING FROM HER SURGICAL WOUND. THE SURGEON DECIDED TO BRING THE PATIENT IN FOR A THOROUGH I&D WHERE HE EXPLANTED THE FEMORAL HIP BALL AND EMPHASYS LINER. THE ACTIS STEM AND EPHESUS ACETABULAR CUP WAS LEFT IN SITU. A NEW HIP BALL AND EMPHASYS LINER WERE IMPLANTED. ACTIVITY LEVEL - YES. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fluid Discharge; Pain

  MAUDE report 23685132 ↗
• MalfunctionNov 6, 2025Difficult to Remove; Difficult to Remove

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT THE CUP GOT STUCK IN THE IMPACTOR AND WAS DISCARDED; THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487619 ↗
• InjuryJul 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR DISLOCATION. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22493156 ↗