PERSONA® Vivacit-E® 42-5124-002-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024236875), received between Oct 4, 2021 and Oct 4, 2021 — classified as 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); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN INITIAL TKA, THE 13 MM PERSONA PS SURFACE WOULD NOT FIXATE ONTO THE TIBIAL STEM. TWO OTHER PERSONA PS SURFACES WERE TRIALED, 12MM AND 14MM, AND WERE ALSO UNABLE TO BE FIXED ONTO THE TIBIAL STEM. ALTERNATIVELY, A 16 MM ARTICULAR SURFACE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY OF 16-30 MINUTES, WITH NO CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568839 ↗

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