EMPHASYS 4732-42-028Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295529514), received between Apr 17, 2025 and Apr 11, 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.

• InjuryApr 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED SURGICAL SITE. HAD A HEAD, POLY, AND LINER EXCHANGE. AFFECTED SIDE- LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24851785 ↗
• InjuryDec 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAS DISLOCATED HIP TWICE SINCE ORIGINAL SURGERY. THE STEM AND CUP ARE WELL FIXED. THE HEAD AND DM LINER WERE REMOVED AND SWAPPED FOR AN ELEVATED RIM LINER AND LONGER HEAD. NO DELAY IN SURGERY OR PATIENT INJURY. NO MORE INFORMATION IS KNOWN. DOI: (B)(6) 2025; DOR: (B)(6) 2025; AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23803398 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HEAD AND LINER WAS EXCHANGED. DOI- UNKNOWN. DOR- (B)(6) 2025. AFFECTED SIDE- UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 23477995 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION THR ON (B)(6) 2025 AND GOT INFECTED POSTOPERATIVELY. A SECOND REVISION WAS PERFORMED. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21912343 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 THE PATIENT UNDERWENT HIP REPLACEMENT DUE TO INFECTION. A WASHOUT WITH HEAD BALL AND LINER EXCHANGE WAS PERFORMED WITHOUT INCIDENT. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21855189 ↗