EMPHASYS 4710-56-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295500629), received between May 16, 2023 and Sep 22, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Migration” (1 report).

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 15 most recent of 15 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 50854073 ↗
• InjuryAug 28, 2026Noise, Audible; Migration

  It was reported that patient had original surgery (b)(6) 2026, a couple weeks after surgery he stood up from the toilet and heard and felt a ¿pop¿ he returned to providers office and X-ray showed cup movement, the cup decreased in inclination but the hip did not dislocate. Cup was revised and 3 screws were placed during revision surgery on (b)(6) 2026. No suggestions of issues or concerns with the implants. No other information provided. It was stated that hip acetabular cup was loose. Loosening interface was marked as non-cemented. Affected side: Left.

  Patient problems: Insufficient Information

  MAUDE report 50495099 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT REVISED FOR INSTABILITY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 25232476 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S HIP DISLOCATED AT HOME. DOCTOR TRIED TO DO A CLOSED REDUCTION UNDER X-RAY, BUT HIP CONTINUED TO DISLOCATE WITH MINIMAL LEG MANIPULATION. DOCTOR REMOVED ACETABULAR COMPONENTS AND REPLACED WITH DUAL MOBILITY FOR MORE STABILITY. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 24551635 ↗
• 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 24269933 ↗
• 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 24245118 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS TAKEN BACK TO SURGERY FOR SUSPECTED INFECTION. THE DOCTOR ELECTED TO REMOVE ALL THE IMPLANTS AND REVISE. EVERYTHING WAS REMOVED WITHOUT ISSUE AND NEW IMPLANTS WERE USED ONCE THE PATIENT WAS WASHED OUT. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23681866 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR HIP REVISION - INFECTION. DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 13 OCT 2025. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: (B)(6) 2025. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: COMPONENTS REMOVED (STEM, HEAD). DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 101854018. LOT NUMBER: 4442962. COMPONENT TYPE: STEM. DESCRIPTION: RECLAIM MONOBLOC REVISION STANDARD STEM 18 STANDARD OFFSET. CATALOG NUMBER: 473246028. LOT NUMBER: 4838000. COMPONENT TYPE: HEAD. DESCRIPTION: EMPHASYS 46 MM X 28 MM AOX MOBILE BEARING HEAD. CATALOG NUMBER: 472556046. LOT NUMBER: 4671538. COMPONENT TYPE: LINER. DESCRIPTION: EMPHASYS 56-58 MM X 46 MM DUAL MOBILITY LINER. CATALOG NUMBER: 471056300. LOT NUMBER: 4925729. COMPONENT TYPE: SHELL. DESCRIPTION: EMSYS SHL 3HOLE 56. CATALOG NUMBER: 121735500. LOT NUMBER: PU209417. COMPONENT TYPE: SCREW. DESCRIPTION: CANCELLOUS BONE SCREW 35MM. CATALOG NUMBER: 121745500. LOT NUMBER: PU216737. COMPONENT TYPE: SCREW. DESCRIPTION: CANCELLOUS BONE SCREW 45MM. CATALOG NUMBER: 136528310. LOT NUMBER: 4369950. COMPONENT TYPE: HEAD. DESCRIPTION: BIOL

  Patient problems: Unspecified Infection

  MAUDE report 23522961 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. ORIGINAL SURGERY HAD AN ACTIS STEM, EMPHASYS CUP, EMPHASYS LINER, AND 40 MM HEAD. ALL THESE PARTS WERE REMOVED BY THE DOCTOR IRRIGATED AND DERIDED THEN RE-PREPPED AND IMPLANTED AN ACTIS COLLARLESS SIZE 9 HIGH STEM, 58 MM EMPHASYS CUP, 40 MM 58 MM EMPHASYS, NEUTRAL LINER, AND A 40 MM +5 FEMORAL HEAD. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22982124 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ORIGINALLY IMPLANTED ON (B)(6) 2025. LATER ON, THE PATIENT DEVELOPED AN INFECTION AND HAD TO BE REVISED WITH A PROSTALAC. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22851250 ↗
• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 22357731 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION OCCURRED ON (B)(6) 2024 DUE TO PAIN. ORIGINAL IMPLANT DATE UNKNOWN.

  Patient problems: Pain

  MAUDE report 20353623 ↗
• InjuryFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SALES REP REMOVED ALL COMPONENTS IN THE HIP DUE TO INFECTION AND REPLACED WITH AN ANTIBIOTIC SPACER. THE HEADBALL AND LINER WERE EXCHANGED ON (B)(6) 2023 (COMPLAINT #: (B)(4)) IN (B)(6) INFECTION WOULD CLEAR. IT DIDN¿T SO EVERYTHING WAS REMOVED. NO ADDITIONAL TIME WAS ADDED. NO CEMENT USED IN INITIAL OR HEADBALL LINER EXCHANGE SURGERIES. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18695107 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY LINER AND HEAD WERE EXCHANGED DUE TO INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN HIP SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 17903998 ↗
• InjuryMay 16, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED WITH CUP DUE TO FALL AND FRACTURE OF ACETABULUM. THERE WAS LOOSENING OF EMPHASYS CUP AT THE BONE TO IMPLANT INTERFACE. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Bone Fracture(s); Fall; Inadequate Osseointegration

  MAUDE report 16939296 ↗