Vivacit-E® 110031314Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024572829), received between Jun 11, 2024 and Feb 27, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K190656); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY AND WAS IMPLANTED WITH ZIMMER BIOMET PRODUCTS. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISLOCATION. THE BEARING AND HEAD WERE EXPLANTED. THE PATIENT WAS REVISED A SECOND TIME DUE TO THE BEARING AND HEAD DISASSOCIATING AFTER DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 21478057 ↗
• InjuryJul 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 1 MONTH AND 21 DAYS POST IMPLANTATION DUE TO INTRA-PROSTHETIC LUXATION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Subluxation

  MAUDE report 19742556 ↗
• MalfunctionJun 11, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE PACKAGING SO A SECOND SET OF STEM, HEAD, AND DUAL MOBILITY LINER WAS OPENED TO ASSURE SAFETY OF PATIENT. THE PROCEDURE WAS COMPLETED WITH NEW IMPLANTS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19515135 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K190656. One submission often covers many models, so check the product and lot details in each record.

• Z-0419-2026 · Sep 26, 2025 · Open, Classified
  Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Catalog Number: 110031013; semi constrained hip prosthesis
• Z-0418-2026 · Sep 26, 2025 · Open, Classified
  Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi constrained hip prosthesis
• Z-0057-2021 · Aug 14, 2020 · Terminated
  Dual Mobility Vivacit-E Bearing, Model Number 110031009