PERSONA® Vivacit-E® 42-5224-004-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024243521), received between Sep 12, 2022 and Oct 15, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Positioning Failure” (1 report).

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.

• InjuryOct 15, 2024Adverse 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: Thrombosis/Thrombus

  MAUDE report 20454928 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE SEVEN YEARS POST IMPLANTATION DUE TO PAIN AND TIBIAL LOOSENING. THE PATIENT WAS SUSPECTED AND TREATED FOR SUBCLINICAL OCCULT INFECTION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Failure of Implant; Pain; Scar Tissue; Subclinical Infection

  MAUDE report 15533930 ↗
• MalfunctionSep 12, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT TOTAL KNEE ARTHROPLASTY WAS PERFORMED. SURGEON HAD A HARD TIME TO INSERT AN ARTICULAR SURFACE IN TIBIA PLATE. SO, HE PRESSED THE ARTICULAR SURFACE TO THE TIBIA PLATE. AT THE SAME TIME, THE TIBIAL PLATE, WHICH WAS FIXED WITH CEMENT, MOVED WITH THE PATIENT TIBIA BONE. AND THE TIBIA CEMENT FIXATION LOOSENED. A SECOND TIBIA WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15402182 ↗

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