PERSONA® Vivacit-E® 42-5224-010-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024243996), received between Mar 30, 2022 and Feb 12, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Ecchymosis; Hematoma; Joint effusion; Muscle/Tendon Damage; Pain; Wound Dehiscence

  MAUDE report 21366031 ↗
• MalfunctionAug 16, 2022Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

  IT WAS REPORTED THAT A SURGEON HAD ISSUES INSERTING AN ARTICULAR SURFACE. AFTER MULTIPLE ATTEMPTS, THE SURGEON TRIED REMOVING ANY DEBRIS AND SOFT TISSUE FROM THE TIBIA BASEPLATE AND STILL HAD NO SUCCESS INSERTING THE IMPLANT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15233943 ↗
• MalfunctionMar 30, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DEVICE WAS NOT LOCKING WITH MATING DEVICE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13952510 ↗

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