EMPHASYS 4722-48-036Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10603295501114), received between Sep 5, 2024 and Aug 31, 2026 — classified as 28 injuries, 2 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50522195 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. AFFECTED SIDE-RIGHT HIP.

  Patient problems: Pain

  MAUDE report 25457260 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 25348772 ↗
• InjuryApr 13, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION OF HIP. MORE STABILITY WAS NEEDED. VERSION AND INCLINATION WAS ADJUSTED WITH NEW CUP AND DUAL MOBILITY WAS USED. THE PREVIOUS UP WAS REMOVED AND A NEW CUP PUT IN AT BETTER VERSION AND INCLINATION. DUAL MOBILITY WAS USED. CUP WAS WELL FIXED JUST IMPLANTED VERTICALLY PREVIOUSLY. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 24861229 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD REVISION ON HEAD AND LINER EXCHANGE DUE TO INFECTION. AFFECTED SIDE- LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24789772 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS INFECTION. DOCTOR DID I&D WASHOUT WITH POLY HEAD BALL SWAP. NOTHING WITH THEIR IMPLANTS; NO DELAY. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24681607 ↗
• MalfunctionFeb 12, 2026Difficult to Insert

  IT WAS REPORTED THAT LINER DID NOT SEAT PROPERLY. HAD TO GO UP A CUP SIZE. AFFECTED SIDE: LEFT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327155 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S JOINT SPACE WAS INFECTED. THEREFORE, ALL HARDWARE WAS REMOVED. DOI: ON (B)(6) 2025, DOR: ON 02 (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24086949 ↗
• MalfunctionJan 6, 2026Difficult to Insert

  IT WAS REPORTED THAT THE LINER WOULD NOT LOCK INTO THE CUP. DOE: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23981842 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DUE TO INFECTION, SURGEON WANTED TO SWAP HEAD AND LINER. NO ALLEGATIONS AGAINST PRODUCTS. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23978108 ↗
• InjuryOct 30, 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. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23424194 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO CONCERN FOR A POSSIBLE INFECTION, THE SURGEON PERFORMED A WASHOUT WITH A HEAD AND LINER EXCHANGE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22829435 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. EVERYTHING CAME OUT. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22827292 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE HEAD AND LINER EXCHANGE DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 22795957 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED TOTAL HIP. SURGEON PERFORMED I&D WITH POLY AND HEAD EXCHANGE. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 22714869 ↗
• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH WASHOUT WITH LINER AND HEAD REPLACEMENT DUE TO POSSIBLE INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22700701 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT WASH OUT. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22642297 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATENT WAS REVISED DUE INSTABILITY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 22499898 ↗
• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HEAD AND LINER WERE EXCHANGED FOR INFECTION. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22187473 ↗
• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CAME TO THE EMERGENCY ROOM WITH A HIP THAT WAS DRAINING AND OOZING. SURGEONS ELECTED TO DO A WASHOUT AND A HEAD AND LINER EXCHANGE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fluid Discharge

  MAUDE report 22098750 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED AND THE SURGEON PULLED CONSTRUCT FOR INFECTION. THE SURGEON PUT IN PROSTALAC INSTEAD. THERE WAS NO IMPLANT FAILURE, NO LOOSENING, NO BROKEN IMPLANTS. THERE WERE NO PIECES LEFT BEHIND. THERE WAS NO SURGICAL DELAY. THERE WERE NO COMPLAINTS FROM SURGEON. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21953458 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HEAD AND LINER WERE EXPLANTED DUE TO INFECTION OF THE LEFT HIP. THEY WERE REPLACED WITH NEW HEAD AND LINER OF THE SAME SIZES. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21935382 ↗
• 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 SHOWING SIGNS OF INFECTION, AND SURGEON DECIDED TO DO HEAD AND POLY SWAP. AFFECTED AREA: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21889957 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BECAME INFECTED. THE (SURGEON) OPENED AND CLEANED THE CAPSULE AND REPLACED THE HEAD AND LINER. THERE WAS NO LOSS OF TIME. DOI: ON (B)(6) 2025, DOR: UNKNOWN, AFFECTED AREA: UNK HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21778827 ↗
• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION OF HEAD AND LINER. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21756180 ↗