EMPHASYS 4722-56-036Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295500407), received between Feb 3, 2025 and Sep 22, 2026 — classified as 7 injuries, 3 malfunctions.

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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised due to suspected infection.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Right Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50854096 ↗
• InjurySep 21, 2026Device Dislodged or Dislocated

  Patient problems: Joint Dislocation

  MAUDE report 50847473 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POLY SWAP DUE TO AN INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24507984 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTION DUE TO IMPLANT. DOI- UNKNOWN. DOR- (B)(6) 2026. AFFECTED SIDE- LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24269652 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENTS HIP WAS REVISED DUE TO INSTABILITY. DURING THE REVISION PROCEDURE, THE PATIENT'S PRIMARY FEMORAL HEAD, ACETABULAR LINER, AND ACETABULAR SHELL WERE REMOVED. THEY WERE REPLACED BY AN EMPHASYS MULTIHOLE ACETABULAR SHELL AND DUAL MOBILITY COMPONENTS FOR ADDED STABILITY. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 24245092 ↗
• MalfunctionDec 12, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THE EMPHASYS LINER WOULD NOT SEAT INTO THE ACETABULAR CUP DURING THE PROCEDURE ON (B)(6) 2025. A 10 MINUTE SURGICAL DELAY WAS NOTED. NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23789317 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. A HEAD LINER EXCHANGE WAS PERFORMED. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22898144 ↗
• InjuryJul 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO DUAL MOBILITY DUE TO MULTIPLE DISLOCATIONS. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22494402 ↗
• MalfunctionJun 20, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE IMPACTED CUP, NO ISSUE, OPENED APPROPRIATE LINER, COULD NOT IMPACT. NO BONE OR SOFT TISSUE INTERFERENCE. OPENED SECOND LINER STILL HAD TROUBLE IMPACTING SECOND LINER. DIDN'T SEEM TO HAVE ANY DAMAGE TO CUP. NO THREADS FROM DOME, NO SOFT TISSUE OR BONE BETWEEN LOCKING MECHANISM. TRIED MULTIPLE ANGLES. EVENTUALLY WAS ABLE TO SEAT SECOND LINER. LISTING CUP AND LINER. ONLY WASTED LINER. DOE: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22299342 ↗
• MalfunctionFeb 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT PATIENT UNDERWENT HIP SURGERY ON (B)(6) 2025. THE LINER BROKE DURING IMPLANTATION. IT WAS BROKEN WITH A BONE TAMP. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: Insufficient Information

  MAUDE report 21293996 ↗