EMPHASYS 4722-56-436Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295500100), received between Apr 21, 2023 and Apr 13, 2026 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Difficult to Insert

  IT WAS REPORTED THAT THE EMPHASYS 56-58 X 36MM +4 NEUTRAL WAS NOT SEATING PROPERLY. THERE WAS NO TISSUE OR ANYTHING IN THE WAY. IT JUST NOT SEATED FULLY. DOE: (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24859746 ↗
• InjuryApr 7, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD A DISLOCATION SO THE SURGEON OPTED TO TAKE OUT THE LINER AND HEAD TO USE A DUAL MOBILITY CONSTRUCT. NO PATIENT COMPLICATIONS DURING CASE. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24802483 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 24582890 ↗
• InjuryNov 18, 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 INFECTION AND INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 23583520 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INSTABILITY. SURGEON MOVED FROM 36 AND TO A DUAL MOBILITY. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 22940533 ↗
• InjuryApr 23, 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 INFECTION. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21891616 ↗
• 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 20353591 ↗
• MalfunctionMay 13, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE IMPLANT WOULD NOT SEAT PROPERLY. IT WAS UNKNOWN WHETHER THERE WAS ANY LOOSENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19305826 ↗
• InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR GI; THROMBOSIS OF SUPERIOR MESENTERIC ARTERY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2023. (LEFT HIP). TREATMENT: UNSPECIFIED TREATMENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16823679 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INTRAOPERATIVE BLEED. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023 (RIGHT HIP). TREATMENT: COILING IS RECOMMENDED TO ADDRESS POTENTIAL LATERAL CIRCUMFLEX BLEED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16786412 ↗