EMPHASYS 4722-52-036Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295501374), received between Jul 10, 2023 and Jun 23, 2026 — classified as 17 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. 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25596199 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY SWAP WAS PERFORMED FOR INFECTION. DOI: ON (B)(6) 2026, DOR: ON (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24667463 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH HEAD AND LINER EXCHANGED WITH I&D FOR ACUTE INFECTION. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24317832 ↗
• InjuryJan 21, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION OCCURRED DUE TO DISLOCATION. CUP ANGLE AND INCLINATION LOOKS NORMAL PER SURGEON. MAKO REVISION CUP. NO IMPLANT FAILURE. NO DELAY. NO OTHER INFORMATION. IMPLANTED BY SAME SURGEON SAME FACILITY. ALL PIECES RETRIEVED. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24133296 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. HEAD LINER EXCHANGE WAS PERFORMED, NOTHING FURTHER TO REPORT. DOI- UNKNOWN. DOR- (B)(6) 2025. AFFECTED SIDE- LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23974981 ↗
• InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD I & D WITH LINER AND HEAD EXCHANGE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23944076 ↗
• InjuryNov 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AS ORIGINAL LINER WAS NOT SEATED FULLY AND HAD UNSTABLE ARTICULATION CUP DID NOT APPEAR DAMAGED. PATIENT'S HEAD AND LINER WERE REPLACED WITH NEW LINER AND TS HEAD. NO PIECES LEFT BEHIND. NO OTHER INFORMATION KNOWN. DOI: ON (B)(6) 2025, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23583159 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD WASH OUT DO TO POOR SKIN HEALING. DOI: (B)(6) 2025 DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Impaired Healing

  MAUDE report 22319066 ↗
• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT WASHOUT WITH ACETABULAR LINER EXCHANGE AND HEADBALL EXCHANGE. THE PATIENT HAD INCREASED REDNESS AND SENSITIVITY; WASHOUT AND LINER/HEADBALL WERE EXCHANGED FOR SUSPECTED INFECTION. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT HIP.

  Patient problems: Erythema; Unspecified Infection

  MAUDE report 22183427 ↗
• InjuryJan 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: NO DELAYS. NO ALLEGATIONS AGAINST THE CUP.

  Patient problems: Joint Dislocation

  MAUDE report 21286311 ↗
• InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INFECTION IN SURROUNDING TISSUES, SURGEON DID WASHOUT AND POLY LINER AND HEAD EXCHANGE. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE : LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21255967 ↗
• InjuryJan 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SMALL AREA IN THE INCISION THAT DRAINED. PATIENT WAS TAKEN TO THE OR TO I&D WITH HEAD AND LINER EXCHANGE. POSSIBLE INFECTION WITH WOUND VAC PLACEMENT. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 21223417 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS 3 WEEKS POST THA. WOUND WAS VERY LONG AND PATIENT WAS NOT HEALING. WOUND AND WAS DRAINING CONSTANTLY. SURGEON OPENED THE WOUND AND FASCIA TO GO INTO JOINT TO WASHOUT AND REPLACE THE LINER AND HEAD WITH NEW COMPONENTS. SURGEON IMPLANTED A NEW LINER AND WENT UP TO A 36MM +5 TS HEAD TO MINIMIZE RISK OF SURGICAL SITE INFECTION DUE TO THE DELAYED HEALING. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fluid Discharge; Impaired Healing

  MAUDE report 20853159 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ITEMS EXPLANTED DUE TO WOUND DRAINAGE. DOI: (B)(6) 2024 , DOR: (B)(6) 2024 , AFFECTED SIDE: UNKNOWN.

  Patient problems: Fluid Discharge

  MAUDE report 20726774 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. ADDITIONAL INFORMATION WAS RECEIVED: WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? - NO. B. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? - NO.

  Patient problems: Unspecified Infection

  MAUDE report 20586186 ↗
• MalfunctionAug 22, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE LINER DIDN¿T SEAT PROPERLY IN CUP. DOE: (B)(6) 2024. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Insufficient Information

  MAUDE report 20027202 ↗
• MalfunctionJun 4, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE LINER WOULD NOT SEAT IN IMPLANTED CUP.

  Patient problems: Insufficient Information

  MAUDE report 19462190 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO HIP DISLOCATING AND UNSTABLE. REVISED SOCKET TO A DUAL MOBILITY WITH A LONGER NECK. DOI- (B)(6) 2023; DOR- (B)(6) 2024; AFFECTED SIDE- RIGHT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 18857588 ↗
• InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A WASHOUT PROCEDURE WAS PERFORMED FOR SUSPECTED INFECTION. THE HEAD AND LINER WERE EXCHANGED. DOI- UNKNOWN. DOR- JUNE 24, 2023. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17288834 ↗