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PERSONA® Vivacit-E® 42-5121-003-16Recalls & 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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024468948), received between Jun 14, 2022 and Jun 14, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (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 18, 2026.

Most reported problems

Device problems

  • Use of Device Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJun 14, 2022Use of Device Problem; Use of Device Problem

    IT WAS REPORTED THAT INCORRECT PRODUCT WAS IMPLANTED INTO A PATIENT. THE SURGEON AND THE SALES REPRESENTATIVE THAT WAS IN THE ROOM WERE FOLLOWED UP WITH TO MAKE THEM AWARE OF THE ISSUE. I WAS INFORMED THAT THE REGULAR PROCESS OF CHECKING THE IMPLANT WITH THE HOSPITAL STAFF DID OCCUR BEFORE THE IMPLANT WAS OPENED, HOWEVER AT THE TIME, NO ONE RECOGNIZED THE ISSUE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14686796 ↗

Other PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices →

Sources and updates

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