EMPHASYS 4722-46-032Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295501046), received between May 9, 2025 and Sep 11, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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.

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

  It was reported that patient was revised due to I&D with head & liner exchange due to suspected infection.DOI: (b)(6) 2026.DOR:(b)(6) 2026.Affected Side: Right.

  Patient problems: Unspecified Infection

  MAUDE report 50731454 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED WITH HEAD AND LINER EXCHANGE DUE TO INSTABILITY. ALL PIECES WERE REMOVED. THERE WAS NO DELAY TO THE CASE AND THERE WAS NO HARM DONE TO THE PATIENT. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 25676817 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS BROUGHT TO OPERATING ROOM FOR AN IRRIGATION AND DEBRIDEMENT. SURGEON EXCHANGED POLYETHYLENE LINER AND FEMORAL HEAD. NO PATIENT CONSEQUENCES. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968078 ↗
• InjuryApr 14, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED DURING THE NIGHT IN BED AND ELECTED TO CHANGE THE VERSION ON THE CUP AND PUT IN AN ELEVATED RIM LINER. DOI: ON (B)(6), 2026, DOR: ON (B)(6) 2026, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 24875541 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD SINGLE STAGE REVISION. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24790777 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT WASH OUT DUE TO INFECTION. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24369721 ↗
• InjuryDec 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23898006 ↗
• InjuryOct 29, 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 OF HEAD AND LINER FOR INSTABILITY. LOOKS NORMAL ON XRAY. SPINAL FUSION. NO IMPLANT FAILURE. NO DELAY. NO OTHER INFORMATION. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 23413766 ↗
• InjuryMay 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION OF THE HIP. REMOVED THE CUP, LINER AND HEAD. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22062439 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. HEAD AND LINER WERE EXCHANGED. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 21992804 ↗