EMPHASYS 4742-05-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295505358), received between Sep 15, 2022 and Dec 5, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PREVIOUSLY IMPLANTED COMPONENTS WERE ALL REMOVED DUE TO AN INFECTION IN THE PATIENT. DOI: (B)(6) 2024, DOR: (B)(6) 2024 , AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 20859339 ↗
• 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 20323428 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR DVT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT:(B)(6) 2024. DATE OF EVENT: (B)(6) 2024. (LEFT KNEE). TREATMENT: ORAL MEDICATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19624861 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR FEMORAL PERIPROSTHETIC FRACTURE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT HIP). TREATMENT: NONE.

  Patient problems: Ambulation or Postural Difficulties; Limb Fracture; Pain

  MAUDE report 17611725 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO PERIPROSTHETIC FRACTURE. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: (B)(6) 2022. (RIGHT HIP). TREATMENT: REVISION; STEM, HEAD, AND LINER WERE REMOVED.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 15427192 ↗