Vivacit-E® 110031014Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024572720), received between Aug 28, 2023 and Aug 28, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).

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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A CEMENTED 54MM, COMPETITOR ACETABULAR CUP WAS IMPLANTED. A -6MM DM LINER (48MM) WAS OPENED, ONLY TO DISCOVER IT WAS TOO LARGE. THE PATIENT HAD PAIN AND SUSPECTED INFECTION, AND A STAGE 1 PROSTALAC WAS PERFORMED. THE ZIMMER BIOMET LINER WAS PLACED IN THE CUP REGARDLESS BECAUSE IT WAS A PROSTALAC TOTAL HIP ARTHROPLASTY AND WILL NEED REVISION. THE SURGEON WAS SATISFIED WITH TIGHTER MOBILITY. IT WAS REPORTED THAT THE LINER WAS BELIEVED TO EITHER BE MISLABELED OR THE IMPROPER LINER TYPE WAS PROVIDED IN THE LOANER KIT. IT MIGHT BE DUE TO IT BEING A ZIMMER BIOMET BEARING AND NOT A COMPETITOR BEARING. REGARDING DELAY OF SURGERY, THERE WAS SOME TIME TO EVALUATE OPTIONS, BUT NOT ENOUGH TO BE MEASURED. IT WAS REPORTED THAT THE PATIENT HAD OLD WORN-OUT IMPLANTS FROM AN OLD SURGERY. THE WORN-OUT IMPLANTS WERE FROM AN UNSPECIFIED COMPANY BUT WERE NOT ZIMMER BIOMET IMPLANTS. THERE WAS NO REPORTED HARM OR INJURY TO THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17637819 ↗

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-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-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-0057-2021 · Aug 14, 2020 · Terminated
  Dual Mobility Vivacit-E Bearing, Model Number 110031009