EMPHASYS 4722-50-036Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10603295501244), received between May 24, 2023 and Sep 24, 2026 — classified as 36 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 39 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Device Dislodged or Dislocated

  It was reported that the patient underwent the revision of an Emphasys cup due to dislocation. The cup was reported to have been implanted too steep/open and retroverted, and the event was described as surgeon error rather than implant fault.

  Patient problems: Joint Dislocation

  MAUDE report 50884874 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the surgeon did head and liner exchange.DOI: Unknown.DOR: (b)(6) 2026.Affected Side: Left.

  Patient problems: Insufficient Information

  MAUDE report 50855024 ↗
• InjurySep 1, 2026Device Dislodged or Dislocated

  It was reported that patient was dislocating. The liner and the head were removed and was replaced with a dual mobility head and liner.DOI: (b)(6)2026.DOR: (b)(6)2026.Affected side: Unknown.

  Patient problems: Joint Dislocation

  MAUDE report 50544592 ↗
• InjuryJun 1, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD DISLOCATED. THE DOCTOR EXPLANTED THE HEAD AND LINER AND REPLACED THEM WITH A LONGER HEAD AND LATERALIZED LINER. DOI: (B)(6) 2024, DOR: UNKNOWN, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 25348555 ↗
• MalfunctionMay 4, 2026Difficult to Insert

  IT WAS REPORTED THAT THE CUP (WITH LINER) HAD NO BITE AND CAME LOOSE DURING FINAL REDUCTION. THE SURGEON HAD TO REMOVE THE NO HOLE IMPLANT AND REPLACE IT WITH THE SAME SIZE CUP BUT WITH SCREWS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072774 ↗
• InjuryApr 22, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO RECURRING DISLOCATION. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 24958603 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO IRRIGATION AND DEBRIDEMENT WITH HEAD AND LINER EXCHANGED. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT HIP.

  Patient problems: Fluid Discharge

  MAUDE report 24685801 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HEAD AND LINER CHANGE AFTER IRRIGATION AND DEBRIDEMENT. THERE WAS NO ALLEGATION AGAINST IMPLANTS. THERE WAS NO WAY TO CONFIRM INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 24536039 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED AS THE IMPLANTS WERE REMOVED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. NO PATIENT CONSEQUENCE. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24428564 ↗
• InjuryFeb 12, 2026Device Dislodged or Dislocated

  ADDITIONAL INFORMATION STATES THAT THE RIGHT IS THE AFFECTED SIDE.

  Patient problems: Joint Dislocation

  MAUDE report 24326855 ↗
• MalfunctionFeb 4, 2026Difficult to Insert

  IT WAS REPORTED THAT LOCKING MECHANISM OF THE DEVICE WAS NOT WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24262081 ↗
• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD PAIN FROM BURSITIS, LOOKS LIKE CUP POSSIBLY MOVED POST OP. PATIENT WAS REVISED TO G7. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inflammation; Pain

  MAUDE report 24134496 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTION IN THE HIP. SURGEON RETAINED ALL COMPONENTS; EXCEPT THEY CHANGED OUT THE LINER AND THE HEAD AND DID IRRIGATION AND DEBRIDEMENT. DOI: ON (B)(6) 2025, DOE: ON (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24058509 ↗
• InjuryDec 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS DISLOCATING SO SURGEON PULLED OUT THE HEAD, LINER, SCREWS, AND CUP. SURGEON IMPLANTED ZIMMER CUP, SCREWS, AND LINER. SURGEON KEPT THE ACTIS STEM SO A NEW DEPUY TS HEAD WAS IMPLANTED . THERE WAS NO KNOWN SURGICAL DELAY. NO PATIENT CONSEQUENCES. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23888468 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF LINER & HEAD DUE TO POST OP INFECTION. DOI: UNKNOWN . DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23596844 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: REVISION DUE TO INFECTION. MODERATE METAL TRANSFER NOTED ON THE FEMORAL HEAD.

  Patient problems: Unspecified Infection

  MAUDE report 23467187 ↗
• InjurySep 4, 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 AN INFECTION THAT WAS DEVELOPED ONE MONTH POSTOP. THERE WAS NO LOOSENING. DOI: ON (B)(6) 2025, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22967513 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO IRRIGATION AND DEBRIDEMENT/IMPLANT EXCHANGE FOR INFECTED TOTAL HIP. NO BROKEN INSTRUMENTS, NO DELAYS, NO ADVERSE EVENTS, NO FURTHER INFORMATION AT THIS TIME. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22848524 ↗
• InjuryJul 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT A TOTAL HIP ARTHROPLASTY REVISION. SWAPPED OUT A NEUTRAL EMPHASIS LINER FOR AN ELEVATED RIM LINER. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22589538 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS INFECTED AND SURGEON WAS SWAPPING THE POLY AND HEAD. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22481717 ↗
• InjuryJul 10, 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 PAIN. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 22467873 ↗
• InjuryApr 22, 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. SURGEON WAS GOING TO SWAP THE HEAD AND LINER, BUT THE STEM CAME OUT EASILY, POSSIBLY DUE TO SEPSIS. THERE WAS NON-CEMENTED LOOSENING OF THE FEMUR. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 21880943 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME BACK TO THE HOSPITAL WITH DRAINING FROM HER TOTAL HIP DONE ONE WEEK AGO. DOCTOR BELIEVED THE JOINT TO BE INFECTED AND PLANNED TO WASH THE JOINT OUT, PLACE ANTIBIOTICS AND SWAP THE POLY AND HEAD WITH THE SAME IMPLANTS. WHILE REMOVING THE FEMORAL HEAD, THE STEM CAME OUT AS WELL. DOCTOR DECIDED TO REMOVE ALL IMPLANTS. DOCTOR USED A COMPETITOR CUP/LINER AND RE-IMPLANTED AN ACTIS AND CERAMIC HEAD. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 21873301 ↗
• InjuryFeb 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT FRACTURED GREATER TROCHANTER AND DISLOCATED HIP. SURGEON DECIDED TO CHANGE THE LINER AND HEAD FOR INCREASED STABILITY. DOI: (B)(6) 2024. DOR: (B)(6) 2025 . AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21425927 ↗
• InjuryJan 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED AND UNDERWENT THE SECOND STAGE OF A WASHOUT FOR INFECTION. THE SURGEON SWAPPED THE HEAD AND POLY AND WASHED THE PATIENT OUT. THE SURGICAL DELAY IS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21287221 ↗