EMPHASYS 4722-52-440Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295501305), received between Jun 14, 2024 and Sep 18, 2026 — classified as 12 injuries.

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. 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to Infection.Affected Side: Left Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50816345 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was being revised due to an infection. This was I&D, head and liner swap. The liner was removed and replaced with a new liner of the same size. The head was also removed and replaced with a revision ceramic head of the same size.DOI - On (b)(6) 2026.DOR - On (b)(6) 2026.Affected side- Left Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50143837 ↗
• InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25692679 ↗
• InjuryJun 24, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT HEAD AND LINER WAS EXCHANGED DUE TO DISLOCATION. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 25612434 ↗
• InjuryApr 21, 2026Device Dislodged or Dislocated; Naturally Worn

  (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: STAGE 2 REMOVAL OF SPACER AFTER SUCCESSFUL INFECTION TREATMENT AND RECURRENT DISLOCATION OF THE HEAD AND LINER. RETRIEVAL ANALYSIS IDENTIFIED WEAR OF THE ACETABULAR LINER.

  Patient problems: Joint Dislocation

  MAUDE report 24943032 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMES IN TODAY WITH A PERI PROSTHETIC FRACTURE. DR REMOVED THE POLY, STEM AND HEAD SINCE THEY WERE LOOSE AND WENT BACK IN WITH A RECLAIM MONOBLOCK STEM. NO FURTHER PATIENT INFORMATION WAS AVAILABLE AT THIS TIME. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 24909500 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO I&D WITH HEAD AND LINER EXCHANGE FOR CONFIRMED INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23362623 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE RECEIVED: ON (B)(6) 2024, THE PATIENT HAD A POST-OPERATIVE CLINIC VISIT. THE PHYSICIAN STATED THAT DUE TO THE OVERLAP OF ABDOMINAL TISSUE, THE INCISION SHOWS A COUPLE AREAS THAT LOOK MOIST AND MACERATED. THE PATIENT WAS TOLD TO TAKE ORAL ANTIBIOTICS AND EDUCATED TO KEEP THE WOUND DRIER BY COVERING WITH A LIGHT GAUZE. ON (B)(6) 2024, THE PATIENT HAD ANOTHER POST-OPERATIVE CLINIC VISIT. THE PHYSICIAN STATES THAT SHE HAD UNDERGONE AN EXPLORATION AND DEBRIDEMENT OF THE WOUND AND ¿THEN IT WAS JUST A SUPERFICIAL WOUND.¿ SHE CONTINUES TO HAVE A SMALL AREA ON THE MEDIAL SIDE WHICH WAS DEBRIDED ¿A BIT LAST TIME¿ AND IS SLOWLY HEALING. THE PATIENT IS OTHERWISE HEALING AND PROGRESSING WELL.

  Patient problems: Impaired Healing

  MAUDE report 20504624 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED: ON (B)(6) 2024, THE PATIENT WAS TREATED OPERATIVELY WITH IRRIGATION AND DEBRIDEMENT, AS WELL AS AN EXCISION/REVISION OF THE PREVIOUS SURGICAL SCAR¿THIS WAS ALL PART OF TREATMENT FOR A SUPERFICIAL WOUND INFECTION OF THE LEFT DIRECT ANTERIOR TOTAL HIP WOUND. THE INCISION WAS RED, SWOLLEN, AND TENDER. CULTURES TESTED POSITIVE FOR MRSA. THE INFECTION WAS ENTIRELY SUPERFICIAL WITH NO DEEP COMMUNICATION TRACTS. NO PRODUCTS WERE REVISED. THE PATIENT WAS SEEN CLINICALLY ON (B)(6) 2024 FOR POST-OPERATIVE FOLLOW-UP. HER WOUND WAS HEALING WELL, AND THE RETENTION SUTURES PLACED ON (B)(6) 2024 WERE REMOVED FROM THE OFFICE.

  Patient problems: Discomfort; Erythema; Post Operative Wound Infection; Swelling/ Edema; Unspecified Infection

  MAUDE report 20323378 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS. CLINICAL ADVERSE EVENTS RECEIVED FOR INFECTION - DEEP DEVICE AND PROCEDURE(RELATEDNESS) DEVICE RELATED: REMOTE POSSIBILITY. PROCEDURE RELATED: PROBABLY. DATE OF IMPLANT: (B)(6) 2024. DATE OF REVISION: (B)(6) 2024. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: REVISION.

  Patient problems: Adhesion(s); Impaired Healing; Pain; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 20052504 ↗
• InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A HEAD AND LINER EXCHANGE WITH IRRIGATION AND DEBRIDEMENT (I&D) FOR INFECTION. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19982562 ↗
• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2024. DATE REVISION: UNK (B)(6) 2024. DATE OF EVENT: (B)(6) 2024. (LEFT HIP). TREATMENT: REVISION; PRODUCTS REVISED UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 19537820 ↗