EMPHASYS 4725-50-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295500865), received between Nov 14, 2024 and Jun 30, 2026 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS SUBLUXING POSTERIOR. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 25665177 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A HEMATOMA AND SURGEON ELECTED TO WASHOUT AND CHANGE MODULAR COMPONENTS. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE- RIGHT HIP.

  Patient problems: Hematoma

  MAUDE report 24691180 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT I&D OF HIP DUE TO SUSPECTED INFECTION. SURGEON EXCHANGED MODULAR COMPONENTS. AFFECTED SIDE- LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23356150 ↗
• InjuryOct 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO RECURRENT DISLOCATION. SURGEON WANTED A CONSTRAINED LINER. WITH NO OPTION HE HAD TO REMOVE THE WELL-FIXED CUP. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23338325 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LINER AND HEAD WAS REMOVED AND REVISION WAS DONE DUE TO INFECTION. DOI (B)(6 2025, DOR (B)(6) 2025, AFFECTED SIDE- LEFT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 23101152 ↗
• MalfunctionJun 30, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT COULD NOT SEAT THE IMPLANT. THE IMPLANT WAS REMOVED AND A SECOND ONE OF THE SAME KIND, WAS OPENED AND SEATED FINE. DOE:(B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22359835 ↗
• InjuryJun 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATED HIP. ORIGINAL IMPLANTS WERE PUT IN (B)(6) 2025 AND IT WAS ON THE RIGHT SIDE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 22324468 ↗
• InjuryJun 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE EMPHASYS DUAL MOBILITY REMOVED. CEMENTED A PINNACLE CONSTRAINED LINER DUE TO KNOW EMHASYS CONSTRAINED LINER OPTION AVAILABLE. REVISED DUE TO MULTIPLE DISLOCATIONS. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22168844 ↗
• InjuryMay 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO MULTIPLE DISLOCATIONS. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22028064 ↗
• MalfunctionNov 14, 2024Difficult to Insert; Difficult to Remove; Difficult to Insert; Difficult to Remove

  IT WAS REPORTED THAT THE METAL EMPHASYS DUAL MOBILITY LINER WENT IN SLIGHTLY ECCENTRIC AND COULD NOT GET IT OUT WITH THE EXTRACTION DEVICE. SURGEON ELECTED TO LEAVE IT AND MOVED ON. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. DOI: (B)(6 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20686121 ↗