EMPHASYS 4722-52-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295501381), received between Jun 7, 2024 and Sep 29, 2026 — classified as 22 injuries.

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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to Infection.DOI: (b)(6)2026.DOR: (b)(6) 2026.Affected Side: Left Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50933752 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50722622 ↗
• InjuryJun 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT NEEDED MORE STABILITY. WENT TO EDM. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 25653032 ↗
• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LATERALIZATION WAS REQUIRED. DOI: (B)(6), 2025 DOR: (B)(6), 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 25205474 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS INFECTED AND NEEDED TO HAVE ALL COMPONENTS REMOVED. ORIGINAL SURGERY WAS DONE (B)(6) 2026, AND DID POLY EXCHANGE/HEAD EXCHANGE ON (B)(6) 2026. DID COMPLETE REMOVAL OF IMPLANTS ON (B)(6) 2026 AND DID SPACER. ACTIVITY LEVEL - YES. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25058744 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24650981 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24443347 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION, REQUIRING POLY SWAP. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24305766 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO HEAD/LINER EXCHANGE DUE TO INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24168713 ↗
• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT SUFFERED FROM INFECTION DUE TO IMPLANT. DOI-(B)(6) 2025. DOR- (B)(6) 2025. AFFECTED SIDE- LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24116337 ↗
• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A PERSISTENT INFECTION IN THEIR LEFT HIP. JOINT WAS WASHED OUT AGAIN AND THE HEAD AND LINER WERE GOING TO BE EXCHANGED, HOWEVER THE CUP CAME LOOSE WHEN TRYING TO EXTRACT THE LINER. THUS, THE HEAD, LINER AND CUP WERE ALL EXCHANGED FOR A MODULAR UNIPOLAR BALL. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24097125 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. HEAD LINER EXCHANGE WAS PREFORMED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24012589 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. IMPLANTS WERE EXTRACTED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23908912 ↗
• 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 INFECTED AS PER SURGEON. SURGEON KEPT INITIAL IMPLANTS AND DID A POLY AND HEAD EXCHANGE. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22469867 ↗
• 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 IRRIGATION AND DEBRIDEMENT OF THE HIP. MODULAR COMPONENTS WERE CHANGED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22183954 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A PRESUMED INFECTION SO THE SURGEON DECIDED TO WASH OUT AND REMOVE ALL THE IMPLANTS. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22004843 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR WAS REVISED ALL THE IMPLANTS TO A CEMENT SPACER DUE TO AN ACTIVE INFECTION. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21910351 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO WOUND CLOSURE ISSUES. PATIENT IS A SMOKER AND CAME IN FOR POST OP FOLLOW UP AND A PORTION OF WOUND HAD NOT HEALED. I&D WAS PERFORMED. THE SURGICAL DELAY IS UNKNOWN. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Impaired Healing

  MAUDE report 21880683 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED HIP. DOI: UNKNOWN AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21308719 ↗
• InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED WITH WASHED OUT DUE TO INFECTED JOINT. SURGEON EXPLANTED HEAD AND LINER AND IMPLANTED NEW HEAD AND LINER. DOI: UNKNOWN, DOR: (B)(6) 2024 , AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20677234 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO ACUTE HIP PAIN. SURGEON ELECTED TO PERFORM AN I&D AND DEBRIDEMENT TO TREAT FOR A POSSIBLE INFECTION OF THE RIGHT HIP. SURGEON TOOK TISSUE SAMPLE TO BE TESTED. AT THE END OF PROCEDURE SURGEON REMOVED THE TWO SCREWS, LINER, AND HEAD FROM THE INDEX SURGERY LEAVING THE CUP AND STEM. HE IMPLANTED A NEW LINER INTO THE INDEX CUP AND ELECTED TO IMPLANT ANOTHER CERAMIC HEAD BEFORE REDUCING THE JOINT AND CLOSING. NO INSTRUMENTS BROKER DURING SURGERY. THERE WERE NO DELAYS. DOI: (B)(6) 2024, DOR: (B)(6) 2024 , AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 20355461 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION OF HIP. SURGEON WASHOUT WITH POLY LINER AND FEMORAL HEAD EXCHANGE. DOI UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19487412 ↗