EMPHASYS 4722-54-436Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295500063), received between Jun 21, 2023 and Jan 12, 2026 — classified as 6 injuries.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED HEAD AND LINER FOR SUSPECTED INFECTION. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24043503 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR POSSIBLE INFECTION. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21315659 ↗
• InjuryJan 10, 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 POSSIBLE INFECTION. A HEAD AND LINER EXCHANGE WAS PERFORMED ALONG WITH A COMBINATION OF PEROXIDE, BETADINE, AND SALINE IRRIGATION. ANTIBIOTICS WERE ALSO GIVEN. THE SURGICAL DELAY IS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21123241 ↗
• InjuryJul 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDICAL RECORDS RECEIVED. ON (B)(6), 2023, THE PATIENT RECEIVED A PRIMARY LEFT DIRECT ANTERIOR APPROACH TOTAL HIP ARTHROPLASTY, USING DEPUY EMPHASYS STEM AND CUP, WITH CERAMIC ON POLY ARTICULATION, TO ADDRESS AVASCULAR NECROSIS OF THE LEFT FEMORAL HEAD. THERE WERE NO REPORTED COMPLICATIONS. ON (B)(6), 2023, THE PATIENT WAS REVISED TO ADDRESS RECURRENT INSTABILITY AND MULTIPLE ANTERIOR HIP DISLOCATIONS. IT WAS DIAGNOSED AS THE CUP BEING MALPOSITIONED WITH TOO MUCH ANTEVERSION, AND WAS MORE VERTICAL THAN INTENDED, ALLOWING IMPINGEMENT IN EXTENSION WITH LEG EXTERNAL ROTATION. BOTH THE EMPHASYS CUP AND EMPHASYS STEM WERE FOUND TO ALREADY HAVE A GOOD FIXATION, THOUGH 2 MONTHS OUT FROM THE IMPLANT DATE. THE CUP WAS EXPLANTED, ALONG WITH THE HEAD, SCREWS, AND LINER; THE STEM WAS RETAINED. A PINNACLE CUP WITH TWO SCREWS WAS PLACED, ALONG WITH A 40MM LINER AND +12 MM 40MM HEAD. THERE WERE NO COMPLICATIONS.

  Patient problems: Joint Dislocation; Joint Laxity; Unspecified Musculoskeletal problem

  MAUDE report 17286748 ↗
• InjuryJun 30, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN EMPHASYS CUP AND STEM CONSTRUCT ON (B)(6) 2023. IT WAS THEORIZED BY SURGEON THAT THE PLACEMENT OF THE CUP IS TOO MUCH ANTERVERSION AND NOT ENOUGH INCLINATION. THE PATIENT HAD SEVERAL ANTERIOR DISLOCATIONS FOLLOWING SURGERY. THERE WAS NO LOOSENING OF ANY COMPONENTS ON THE CUP OR STEM SIDE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17242729 ↗
• InjuryJun 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR ANTERIOR HIP DISLOCATION TWICE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (LEFT HIP). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Joint Dislocation

  MAUDE report 17171386 ↗