EMPHASYS 4722-56-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295500414), received between Oct 19, 2023 and Sep 2, 2026 — classified as 20 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50572914 ↗
• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised due to infection.DOI: on (b)(6) 2026,DOR: on (b)(6) 2026,Affected side: Left Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50116168 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Head and poly were removed and replaced due to infection.DOI: Unknown. DOR: (b)(6) 2026. Affected Side: Left Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50062682 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient showed signs of possible infection. Doctor washed out the hip and exchanged the head and liner.DOI: Unknown,DOR: Unknown,Affected side: Left Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50012644 ↗
• InjuryJul 27, 2026Device Dislodged or Dislocated

  It was reported that the Patient was dislocating posterior. Doctor revised to an elevated rim liner and put a new head ball in as well.DOI: Unknown,DOR: Unknown,Affected side: Right.

  Patient problems: Joint Dislocation

  MAUDE report 50011405 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS INFECTED. SURGEON WASHED JOINT OUT AND CHANGED HEAD AND LINER. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25677047 ↗
• MalfunctionJun 2, 2026Difficult to Insert

  THE SURGEON STATED THAT THE LINER DID NOT SEAT PROPERLY. AFTER MULTIPLE TRIES THE ARDS WERE NOT DOWN AND NOTHING WAS IN HIS WAY. DOE: (B)(6) 2026. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25364261 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2026. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: INFECTION. RETRIEVAL ANALYSIS SHOWS WEAR OF THE CERAMIC FEMORAL HEAD.

  Patient problems: Unspecified Infection

  MAUDE report 24943262 ↗
• InjuryFeb 20, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS DISLOCATING DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24403251 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL A FEW WEEKS BACK AND OPENED UP THEIR INCISION, WENT TO ER AND HAD IT STAPLED. WOUND OPENED AND STARTED DRAINING SO DOCTOR TOOK BACK TO THE OR FOR AND I&D. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fluid Discharge; Wound Dehiscence

  MAUDE report 24256863 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN WITH AN INFECTED RIGHT HIP. PATIENT WAS WASHED OUT, AND HEAD AND LINER WERE EXCHANGED. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24178594 ↗
• InjuryJan 14, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS DISLOCATING. DOCTOR WANTED TO INCREASE HEAD SIZE AND POLY OFFSET. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24072587 ↗
• InjuryJan 13, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD A POST-OPERATIVE DISLOCATION WHICH RELATES TO SPINOPELVIS VERSUS SOFT TISSUE. DOI: (B)(6) 2024, DOR- UNKNOWN, AFFECTED SIDE- LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24059961 ↗
• 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 23681902 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. SURGEON REMOVED THE LINER AND HEAD FOR A WASHOUT. NEW LINER AND HEAD IMPLANT WAS THEN IMPLANTED INTO THE PATIENT. DOI: UNKNOWN DATE, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23073889 ↗
• 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 22981842 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HEAD AND LINER WERE REMOVED FROM INFECTED HIP TO ACHIEVE PROPER WASH OUT OF JOINT. NEW HEAD AND LINER IMPLANTED. DOI: (B)(6) 2025, DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22593037 ↗
• InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 21606654 ↗
• InjuryFeb 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A TRAUMATIC FALL AND DISLOCATED HIS HIP. SINCE THE FALL, PATIENT HAS EXPERIENCED ADDITIONAL DISLOCATIONS OF THE SAME HIP. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 21322818 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD I&D LEFT HIP 3 WEEKS POST OP. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN, DOR- (B)(6) 2024.

  Patient problems: Erythema; Inflammation; Insufficient Information; Unspecified Infection; Wound Dehiscence

  MAUDE report 20558833 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WENT TO THE ER COMPLAINING OF HIP PAIN. X-RAYS CONFIRMED THAT THE IMPLANTS WERE WELL FIXED AND APPROPRIATE SIZE. SURGEON TOOK FLUIDS IN HIS OFFICE AND DETERMINED THE PATIENT MAY BE INFECTED. SURGEON BROUGHT THE PATIENT IN THE OR TO DO AN I&D AND TO TAKE DEEP CULTURES. RESULTS OF THOSE LABS ARE UNKNOWN. HE EXCHANGED THE HEAD BALL AND THE LINER AS A PRECAUTIONARY MEASURE FOR INFECTION. NOTHING WRONG WITH THE IMPLANTS THEMSELVES OR THE PLACEMENT AND INTRA-OPT CONFIRMED THAT. DOI- (B)(6) 2023, DOR- (B)(6) 2023, AFFECTED SIDE- LEFT HIP.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17967958 ↗