Vivacit-E® 110031015Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024572737), received between Jul 21, 2021 and Feb 18, 2026 — classified as 2 injuries, 1 malfunction.

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

• MalfunctionFeb 18, 2026Positioning Failure; Unclear Information

  IT WAS REPORTED THAT DURING AN INITIAL TOTAL HIP ARTHROPLASTY, THE CORRECT INLAY WAS OPENED FOR THE SHELL HOWEVER THE INLAY WOULD NOT FIT AND WAS UNABLE TO BE PROPERLY POSITIONED. A BACKUP DEVICE WAS USED TO THE COMPLETE THE PROCEDURE WITHOUT FURTHER COMPLICATION. THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24380550 ↗
• InjuryOct 13, 2021Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 5 DAYS POST IMPLANTATION DUE TO DISLOCATION. DURING THE REVISION THE ACETABULAR SHELL WAS IN A DIFFERENT POSITION FROM PREVIOUS SURGERY. THE SHELL, LINER, BEARING, SLEEVE, AND HEAD WERE EXCHANGED WITHOUT COMPLICATIONS. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 12627931 ↗
• InjuryJul 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 1 WEEK POST IMPLANTATION DUE TO INFECTION. ALL DEVICES WERE REMOVED AND REPLACED WITH COMPETITOR CEMENT SPACERS. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Unspecified Infection

  MAUDE report 12205291 ↗

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