PERSONA® Vivacit-E® 42-5220-005-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024241633), received between Jul 26, 2021 and Mar 25, 2025 — 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, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2025Positioning Failure; Positioning Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21686794 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. THE SAME DAY, THE PATIENT WAS DIAGNOSED WITH BILATERAL LOWER LOBE PNEUMONIA THROUGH CHEST X-RAY. THE PATIENT WAS PLACED ON AUGMENTIN FOR 7 DAYS. THE PNEUMONIA RESOLVED 3 WEEKS LATER WITHOUT FURTHER COMPLICATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pneumonia

  MAUDE report 15990476 ↗
• InjuryJul 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT TKA APPROXIMATELY 3 YEARS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION FOR PAIN. THE SURGEON OPTED TO DO A WASHOUT, AND IMPLANTED A THINNER ARTICULAR SURFACE.

  Patient problems: Pain

  MAUDE report 12224818 ↗

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