PERSONA® Vivacit-E® 42-5224-005-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024243637), received between Feb 21, 2023 and Nov 18, 2025 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT AN ARTICULAR SURFACE DIDN¿T MATE WITH TIBIAL PLATE. THE SURGEON CAREFULLY TRIED TO INSERT IT, AFTER THAT, IT WAS DISCOVERED THAT THE BACK SIDE OF THE ARTICULAR SURFACE WAS DEFORMED. THE SURGERY WAS COMPLETED WITH ANOTHER ARTICULAR SURFACE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23586484 ↗
• InjuryFeb 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA TWO MONTHS POST IMPLANTATION DUE TO STIFFNESS AND ARTHROFIBROSIS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE. UPON MANIPULATION UNDER ANESTHESIA IT WAS NOTED POST-OP THERE WAS A FLEXION IS IMPROVING- ABLE TO BEND QUITE WELL ON HER OWN, WHEN WALKING, REPORTS FEELING OF STIFFNESS, FEELS CONTINUING TO PROGRESS SLOWLY ¿ OFF ALL PAIN MEDICATIONS, NO SIGNS OF SUBSIDENCE OR LOOSENING.

  Patient problems: Discomfort; Loss of Range of Motion; Scar Tissue

  MAUDE report 16408066 ↗

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