PERSONA® Vivacit-E® 42-5224-009-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024243965), received between Jul 9, 2024 and Jul 9, 2024 — classified as 1 injury.

2 other recalls cover devices cleared under the same FDA submission (K121771); 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 18, 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.

• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A KNEE SURGERY AND SUBSEQUENTLY BEGAN TO EXPERIENCE PAIN, HYPEREXTENSION, AND INSTABILITY. THE PATIENT THEN EXPERIENCED A FALL WITHOUT INJURY AFTER HIS KNEE GAVE OUT AND IS CURRENTLY WALKING WITH CRUTCHES AND A KNEE BRACE. THE PATIENT HAS CONSULTED WITH SEVERAL SURGEONS WITH RECOMMENDATIONS FOR A REVISION. NO REVISION IS CURRENTLY PLANNED AS THE PATIENT IS SEEKING THE BEST ROUTE BEFORE PROCEEDING. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Fall; Hyperextension; Joint Laxity; Joint effusion; Pain

  MAUDE report 19705096 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121771. One submission often covers many models, so check the product and lot details in each record.

• Z-1917-2016 · May 11, 2016 · Terminated
  Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.
• Z-1266-2015 · Jan 28, 2015 · Terminated
  Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer For use in eit