PERSONA® Vivacit-E® 42-5124-005-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024237094), received between Mar 2, 2021 and May 22, 2024 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2024Difficult to Insert; Difficult to Insert

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

  Patient problems: Failure of Implant

  MAUDE report 19370802 ↗
• MalfunctionOct 10, 2023Difficult 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 17905772 ↗
• InjuryAug 9, 2022Material Erosion; Material Erosion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. APPROXIMATELY TWO YEARS POST-IMPLANTATION, THE PATIENT STARTED TO EXPERIENCE PAIN IN THE KNEE. THE PRODUCTS WERE ULTIMATELY REVISED FOUR YEARS AND FOUR MONTHS POST INITIAL IMPLANTATION. DURING THE SURGERY, THE ARTICULAR SURFACE WAS FOUND TO BE WORN, THE TIBIAL COMPONENT WAS FOUND TO HAVE LOOSENED AND MIGRATED, AND THE FEMORAL COMPONENT WAS LOOSENED. THE SURGEON THEORIZED THAT THE LOOSENING WAS CAUSED BY AN INFLAMMATORY REACTION TO ABRASION PARTICLES AND CEMENT TECHNIQUE ERROR. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 15190747 ↗
• MalfunctionDec 29, 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 13108458 ↗
• InjuryMar 8, 2021Unstable; Unstable

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

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 11434600 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL LEFT TKA APPROXIMATELY 3.5 YEARS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA AND CORTICOSTEROID INJECTION DUE TO STIFFNESS/DECREASED ROM CAUSED BY ADHESIONS APPROXIMATELY 3 WEEKS LATER.

  Patient problems: Adhesion(s); Loss of Range of Motion; Muscular Rigidity

  MAUDE report 11401751 ↗

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