EMPHASYS 4722-50-436Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295501183), received between Jan 9, 2024 and Feb 5, 2026 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE CUP WAS REVISED DUE TO ACETABULAR TRAUMA FROM A FALL. DOI: (B)(6) 2023, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Bone Notching; Fall

  MAUDE report 24270847 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTION THA. AFFECTED SIDE- LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24068750 ↗
• InjuryDec 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT FELL AND DISLOCATED, REPLACED LINER WITH A DM. NO ALLEGATION AGAINST THE CUP. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 23817503 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23457879 ↗
• MalfunctionSep 8, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT SURGEONS WAS NOT HAPPY WITH CUP POSITION SO SURGEON DECIDED TO CHANGE TO AN ELEVATED RIM LINER. REMOVING THE LINER WAS VERY DIFFICULT AND ADDED TIME TO THE SURGERY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 22993647 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS HAD PERSISTENT DRAINAGE FROM HER HIP INCISION SINCE INITIAL SURGERY. SURGEON PLANS TO DO A HEAD AND POLY SWAP AND I&D OF THE HIP JOINT. DOI: (B)(6) 2025, DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Fluid Discharge

  MAUDE report 22559682 ↗
• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO.

  Patient problems: Unspecified Infection

  MAUDE report 21364029 ↗
• InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED JOINT. THERE WAS NON-CEMENTED LOOSENING OF THE CUP, SUSPECTED FROM LYSIS AND INFECTION. EVERYTHING WAS EXPLANTED AND A SPACER WAS PUT IN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20676657 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED: ON (B)(6) 2024, MEDICAL RECORDS NOTED THE PATIENT IS 6 WEEKS POST HIP ARTHROPLASTY. IT WAS SAID THAT THE PATIENT HAD A CT SCAN TWO WEEKS AGO AND IT SHOWED A PULMONARY EMBOLISM. THE PATIENT WAS PRESCRIBED ELIQUIS MEDICATION AND OVERALL IS DOING WELL. ON (B)(6) 2024, THE PATIENT IS NOW 3 ½ MONTHS OUT FROM A RIGHT TOTAL HIP IT WAS NOTED THAT THE PATIENT HAD A PE AFTERWARDS. DEPUY STEM AND CUP ARE REPORTED TO BE WELL PLACED ON A RADIOGRAPH.

  Patient problems: Pulmonary Embolism

  MAUDE report 20280874 ↗
• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INSTABILITY AND CHANGED TO LONGER HEAD AND LIPPED LINER. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 19579460 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO REDNESS AND SWELLING. SHE WAS SUPERFICIALLY WASHED OUT OVER THE WEEKEND AND CULTURES DETERMINED THERE TO BE A "BUG". SURGEON DECIDED IT BEST TO WASH THE HIP OUT IN THE JOINT, SWAP THE HEAD AND POLY WITH THE SAME IMPLANTS. HE ALSO PLACED ANTIBIOTIC BEADS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6), 2023. DOR: (B)(6), 2024. AFFECTED SIDE: LEFT.

  Patient problems: Erythema; Swelling/ Edema; Unspecified Infection

  MAUDE report 18474954 ↗