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PERSONA® Vivacit-E® 42-5221-008-14Recalls & reported problems

Zimmer, Inc. · Class 2 · Implant

All models of PERSONA Vivacit-E (285)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024468450), received between Jun 13, 2023 and Jun 13, 2023 — classified as 1 injury.

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 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Hematoma1
  • Impaired Healing1
  • Pain1

Recent adverse event reports

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

  • InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, ONE MONTH LATER, THE PATIENT UNDERWENT AN I&D AND A POLYETHYLENE LINER EXCHANGE. DURING THE PROCEDURE IT WAS NOTED WHAT APPEARED TO BE AN OLD HEMATOMA AND NO EVIDENCE OF PURULENCE, NO PUS, OR OTHER SIGNS OF INFECTION. THE LINER WAS EXCHANGED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Patient problems: Hematoma; Impaired Healing; Pain

    MAUDE report 17120920 ↗

Other Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive devices

All Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive devices →

Sources and updates

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