EMPHASYS 4722-54-036Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295500360), received between Nov 5, 2024 and Sep 11, 2026 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 8 most recent of 8 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 having infectionDOI: Unknown DOR: (b)(6), 2026Affected side: Unknown

  Patient problems: Unspecified Infection

  MAUDE report 50732604 ↗
• InjuryJun 12, 2026Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. CONVERTED TO DM. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 25489002 ↗
• InjuryNov 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A SIZE 6 HO ACTIS, EMPHASYS 3 HOLE CUP SIZE 54 WITHOUT SCREWS, NEUTRAL 54X36 LINER AND 36X 1.5 ARTICULEZE CERAMIC HEAD IMPLANTED ONE YEAR AGO. ANTERIOR APPROACH. THE SURGEON STATED THAT THE PATIENT HAD ONE EPISODE OF A 'MISSTEP' WHERE THE PATIENT DISLOCATED ANTERIORLY. REDUCTION WAS PERFORMED CLOSED WITHOUT FURTHER DISLOCATIONS. THE SURGEON NOTED THAT THE PATIENT CONTINUES TO REPORT THAT THE HIP FEELS ABNORMAL AND UNSTABLE. PATIENT WAS BROUGHT TO THE OR AND THE HEAD AND LINER WAS REMOVED. AN EMPHASYS 54MM LINER WAS IMPLANTED WITH A 28X5MM CERAMIC TS HEAD. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23470521 ↗
• InjurySep 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION. CONVERTED TO A DUAL MOBILITY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22964531 ↗
• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AFTER PRIMARY HIP AND FRACTURED ACETABULUM. SURGEON REMOVED ALL IMPLANTS AND PUT IN NEW COMPONENTS. THERE WERE NO COMPLAINTS OR DELAYS. IMPLANTS UNAVAILABLE FOR RETURN. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP

  Patient problems: Fall

  MAUDE report 22100253 ↗
• MalfunctionApr 29, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE EMPHASYS LINER WOULD NOT SEAT CORRECTLY IN CUP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED AREA: UNKNOWN HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925949 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THEIR INITIAL SURGERY ON (B)(6) 2025. UNFORTUNATELY, THEIR HIP BECAME INFECTED. SURGEON WANTED TO PERFORM A SINGLE STAGE REVISION WHERE HE EXPLANTED THE COMPONENTS AND WENT BACK IN WITH NEW IMPLANTS. ONCE THE IMPLANTS WERE TAKEN OUT, IT WAS THOROUGHLY WASHED AND THE BONE WAS THEN PREPPED FOR NEW IMPLANTS. HIP WAS THEN REDUCED AND FOUND TO BE STABLE. CLOSING PROCESS BEGAN. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21676866 ↗
• InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVISION HIP SURGERY ON (B)(6) 2024. PATIENT WAS REVISED DUE TO INFECTION. SURGEON REMOVED AND IMPLANTED A PROSTALAC. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20614300 ↗