EMPHASYS 4710-54-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295500612), received between Jun 30, 2023 and Sep 2, 2026 — classified as 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50575601 ↗
• InjuryJul 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HEAD AND LINER REVISED DUE TO INFECTION. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25736740 ↗
• InjuryJun 19, 2026Migration

  IT WAS REPORTED THE PATIENT CUP WAS LOOSE AND MIGRATED. THE CUP WAS REVISED TO A BIGGER SIZE AND SCREWS.

  Patient problems: Joint Laxity

  MAUDE report 25563365 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT KEPT DISLOCATING DUE TO POSSIBLE IMPINGEMENT COMBINED WITH PATIENT PUSHING HER RANGE OF MOTION TOO SOON AFTER SURGERY AND WASN'T FULLY HEALED BEFORE RESUMING REGULAR PHYSICAL ACTIVITY. SURGEON PUT IN COMPETITOR'S CUP AND SWITCHED OUT HEAD TO MATCH. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 25003401 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SEPTIC. DURING AN ATTEMPTED IRRIGATION AND DEBRIDEMENT, THE INFECTION WAS FOUND TO BE WORSE THAN ANTICIPATED, LEADING TO THE REMOVAL OF ALL IMPLANTS AND PLACEMENT OF ABX (ANTIBIOTIC) SPACER BLOCKS FOR A PLANNED STAGED REVISION. ALL DEVICES WERE EXPLANTED WITHOUT DIFFICULTY. AFTER IMPLANTATION AND REDUCTION OF THE ANTIBIOTIC SPACER, THE PATIENT WAS CODED. DOI: (B)(6), 2025 DOR: UNKNOWN AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23966495 ↗
• InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK FOR Q4 OF 2025. DARTMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION FOR INFECTION AND PAIN. THE ARTICULAR SURFACE OF THE CERAMIC FEMORAL HEAD SHOWS MINOR METAL TRANSFER.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23933708 ↗
• InjuryOct 22, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF CUP AT NON-CEMENTED INTERFACE. CEMENT MANUFACTURE WAS UNKNOWN. AFFECTED SIDE: LET HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23356982 ↗
• MalfunctionApr 30, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE IMPLANT IN THE BOX WAS A 48MM CUP AND THE BOX WAS LABELED AS 54MM CUP. A SECOND 54MM CUP WAS ON HAND SO THERE WAS NO DEVIATIONS TO THE PROCEDURE OR CONSEQUENCES TO THE PATIENT. NO SURGICAL DELAY WAS REPORTED. AFFECTED SIZE: UNKNOWN HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934129 ↗
• 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 20612331 ↗
• MalfunctionMay 21, 2024Fracture; Device-Device Incompatibility; Fracture; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED: NO HARMFUL EVENT TO REPORT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19358948 ↗
• InjuryFeb 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6); STUDY NO: DOTS. CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO PERIPROSTHETIC FRACTURE. DATE OF IMPLANT: (B)(6) 2023; DATE OF REVISION: (B)(6) 2024; (LEFT HIP). TREATMENT: STEM AND HEAD WERE REVISED. MEDICAL RECORDS REVIEW (22_JAN_2024_08_09_04_18105): ON (B)(6) 2024, PATIENTS LEFT TOTAL HIP WAS REVISED TO ADDRESS CHRONIC INFECTION WITH PROGRESSION OF PERIPROSTHETIC OSTEOLYSIS OF BOTH FEMORAL AND ACETABULAR BONE. DURING THE REVISION SURGICAL PROCEDURE, IT WAS IDENTIFIED THAT THE FEMORAL STEM WAS LOOSE, THAT IT HAD ONLY A FIBROUS INGROWTH. THERE WAS AN OSTEOLYTIC DEFECT BENEATH THE SUPERIOR ASPECT OF THE ACETABULAR CUP, BUT THE CUP WAS WELL-FIXED. THERE WAS OSTEOLYSIS OF THE FEMORAL CANAL. THE STEM, FEMORAL HEAD, CUP, LINER AND TWO ACETABULAR SCREWS WERE ALL EXPLANTED. A TEMPORARY ANTIBIOTIC SPACER, MADE UP OF AN ANTIBIOTIC CEMENTED DEPUY SUMMIT STEM, WAS CEMENTED IN PLACE ALONG WITH STIMULANT PELLETS, AND PAIRED WITH A BIPOLAR HEAD. TWO SYNTHES CERCLAGE CABLES WERE PLACED ON THE PROXIMAL FEMUR TO ADDRESS A CALCAR FRACTURE THAT OCCURRED INTRAOPERATIVELY DURING BROACHING FOR THE SPACER SUMMIT STEM. THE PATIENT TOLERATED THE PROCEDURE WELL, WITH NO OTHER COMPLI

  Patient problems: Osteolysis; Unspecified Infection; Unspecified Musculoskeletal problem

  MAUDE report 18641169 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18435580 ↗
• InjuryJul 17, 2023Use of Device Problem; Use of Device Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO RECURRENT DISLOCATIONS. DATE OF IMPLANT: ON (B)(6) 2023, DATE OF REVISION: ON (B)(6) 2023, (LEFT HIP). TREATMENT: HEAD, LINER, AND CUP WERE REVISED. WERE DEPUY COMPONENTS REMOVED: YES.

  Patient problems: Joint Laxity; Unspecified Musculoskeletal problem

  MAUDE report 17333931 ↗
• InjuryJun 30, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN EMPHASYS CUP AND STEM CONSTRUCT ON (B)(6) 23. 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: Insufficient Information

  MAUDE report 17241084 ↗