EMPHASYS 4710-52-900Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295502951), received between Nov 15, 2023 and May 12, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 22004788 ↗
• 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 21910319 ↗
• MalfunctionNov 15, 2023Migration; Migration

  MEDICAL RECORDS REVIEWED BY A CLINICIAN. DOE: (B)(6) 2023: PATIENT REPORTS TO CLINIC FOR POST-REVISION OF RIGHT HIP CHECKUP AT 8 WEEKS. PATIENT REPORTS SOME WALKING DIFFICULTY. THE X-RAY IDENTIFIES A SUPERIOR MIGRATION OF THE CUP, WHICH WAS CONCERNING SINCE THE CUP POSITIONING WAS STABLE THREE WEEKS PREVIOUS. THE PHYSICIAN SENT THE PATIENT FOR A CT SCAN TO DETERMINE IF THERE WAS AN ACETABULAR FRACTURE CAUSING THE MIGRATION. CT SCAN RESULTS DO NOT IDENTIFY A CAUSE FOR THE CUP MIGRATION. THE PATIENT IS TREATED CONSERVATIVELY WITH WEIGHT-BEARING RESTRICTIONS. THE PREVIOUS REVISION TO TREAT MALPOSITIONING OF THE CUP, RECURRENT DISLOCATIONS, AND INSTABILITY IS CAPTURED ON (B)(4). DOI: (B)(6) 2023 (CUP, HEAD, LINER), DOE: (B)(6) 2023, RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s)

  MAUDE report 18139626 ↗