EMPHASYS 4725-46-036Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295500841), received between Dec 3, 2025 and Dec 9, 2025 — classified as 2 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTS WITH POST OPERATIVE INFECTION POST HIP REPLACEMENT FROM A FAILED CEPHALOMEDULLARY NAIL. ALL DEPUY COMPONENTS ARE PERFORMING AS EXPECTED. COMPONENTS ARE REMOVED AND REPLACED DURING AND EXTENSIVE IRRIGATION DEBRIDEMENT AND PLACEMENT OF ANTIBIOTIC BEADS. DELAY WAS DUE TO A MALFUNCTIONING INSTRUMENT THAT WAS SUBMITTED IN A SEPARATE DER. NO PATIENT HARM OCCURRED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 23759822 ↗
• InjuryDec 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO CHRONIC DISLOCATION. REVISED FROM ORIGINAL NEUTRAL LINER TO DM-STILL DISLOCATING. REVISED TO MAKO TRIDENT AND DM. RETAINED STEM. NO OTHER INFORMATION KNOWN. UNABLE TO READ LOT NUMBER ON CUP. ALL PIECES RETRIEVED. NO OTHER INFORMATION KNOWN DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23705594 ↗