PERSONA® Vivacit-E® 42-5224-005-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024243590), received between Jan 27, 2020 and Sep 27, 2024 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2024Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, THE ARTICULAR SURFACE DIDN'T MATE WITH TIBIA PLATE ALTHOUGH THE SURGEON CHECKED IF THERE WERE NO CEMENT PARTICLES AND SOFT TISSUES BETWEEN THE IMPLANTS PRIOR TO INSERTION. AS A RESULT, THE SURGERY WAS COMPLETED WITH ANOTHER ARTICULAR SURFACE. THE SURGEON COMMENTED THAT ONCE THE ARTICULAR SURFACE WAS REMOVED, HE EXAMINED THE BACK AND FOUND THAT THE MEDIAL POSTERIOR AREA WAS DEFORMED. IT IS REPORTED THAT THE SURGEON SUSPECTS THE BACK OF THE ARTICULAR SURFACE WAS DEFORMED PRIOR TO USE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20320993 ↗
• MalfunctionMar 13, 2024Positioning Failure; Positioning Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18894769 ↗
• InjuryOct 10, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Insufficient Information

  MAUDE report 17907143 ↗
• MalfunctionDec 6, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING ATOTAL KNEE ARTHROPLASTY, WHEN INSERTING THE ARTICULAR SURFACE INTO TIBIA PLATE, IT DIDN'T DEEPLY MATE WITH THE TIBIA PLATE. AFTER SURGEON CONFIRMED THERE WERE NOT CEMENT PARTICLES AND SOFT TISSUE BETWEEN THESE IMPLANTS, HE TRIED SOME INSERTIONS AGAIN. HOWEVER, THE PROBLEM PERSISTED. SUBSEQUENTLY, A SECOND ARTICULAR SURFACE WAS USED TO COMPLETE THE PROCEDURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15925132 ↗
• InjuryAug 31, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: Failure of Implant; Joint Laxity; Metal Related Pathology; Pain

  MAUDE report 12396923 ↗
• InjuryDec 16, 2020Adverse 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: No Code Available; Pain

  MAUDE report 11021688 ↗
• InjuryJan 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Loss of Range of Motion

  MAUDE report 9631501 ↗

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