EMPHASYS 4722-54-440Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295500070), received between May 6, 2025 and Jan 23, 2026 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THE AFFECTED AREA IS ON THE LEFT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 24162787 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED AND NEEDED TO BE WASHED OUT AND PUT A NEW LINER AND HEAD IN WITH ANTIBIOTICS. DOI (B)(6) 2025, DOR (B)(6) 2025, AFFECTED SIDE- UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23296699 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT STARTED HAVING REDNESS AROUND THE INCISION. DETERMINED THAT IT COULD BE INFECTED RESULTING IN AND I&D. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 22914167 ↗
• InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A FALL POST-OPERATIVELY AND DEVELOPED AN UNSTABLE HIP CONSTRUCT. SURGERY PERFORMED TO SWITCH LINER/HEAD TO DUAL MOBILITY AND ADD LEG LENGTH TO ADD STABILITY. DOI: ON (B)(6) 2025, DOE: ON (B)(6) 2025, AFFECTED SIDE: RGHT HIP.

  Patient problems: Fall; Joint Laxity

  MAUDE report 22457809 ↗
• InjuryMay 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED TOTAL HIP SO DOCTOR PUT IN A DUAL MOBILITY FOR MORE STABILITY. DOI: (B)(6) 2025, DOR: UNKNOWN, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21968867 ↗