EMPHASYS 4725-56-046Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295500896), received between Mar 25, 2025 and Nov 11, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: SUBJECT ID: (B)(6). STUDY NO: (B)(4). 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 TYP

  Patient problems: Unspecified Infection

  MAUDE report 23522821 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT AN I+D SURGERY DUE TO INFECTION. SURGEON REMOVED THE ACETABULAR DUAL MOBILITY LINER AND FEMORAL HEAD AND WASHOUT THE JOINT AND THEN REPLACED THE LINER AND HEAD WITH NEW IMPLANTS OF THE SAME SIZE. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22556842 ↗
• InjuryJun 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD FELL AND FRACTURE HIS HIP BELOW THE STEM AND DUAL MOBILITY LINER WAS ALSO LOOSE. DOCTOR WANTED TO REVISE TO A REVISION STEM AND DUAL MOBILITY COMPONENTS. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 22151615 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BECAME INFECTED. ALL COMPONENTS (EXCEPT CUP) WERE REMOVED AND NEW IMPLANTS WERE INSERTED AFTER IRRIGATION. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21687087 ↗