PERSONA® Vivacit-E® 42-5222-004-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024242982), received between Feb 6, 2020 and Apr 26, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K121771, K172524); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2021Difficult to Insert; Difficult to Insert

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11723234 ↗
• InjuryFeb 6, 2020Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT REPORTED SEVERE PAIN, SWELLING, DIFFICULTY WITH ACTIVITIES OF DAILY LIFE, VALGUS, AND UNSTEADINESS. PATIENT STATES SHE CANNOT STRAIGHTEN HER LEG OR RETURN TO NORMAL ACTIVITY DESPITE HOME EXERCISES AND CPM THERAPY. PATIENT ALSO REPORTS THAT APPROXIMATELY ONE WEEK AFTER SURGERY, SHE WAS TREATED WITH IV ANTIBIOTICS FOR CELLULITIS IN HER KNEE. PATIENT PLANS TO FOLLOW UP FOR POTENTIAL REVISION SURGERY, BUT NO REVISION HAS OCCURRED TO DATE.

  Patient problems: Cellulitis; Loss of Range of Motion; Pain; Swelling; Swelling/ Edema; Unspecified Infection

  MAUDE report 9676554 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121771, K172524. 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