PERSONA® Vivacit-E® 42-5220-006-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024241695), received between Dec 2, 2019 and Sep 18, 2024 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unstable” (3 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT ARTICULAR SURFACE PROSTHESIS WAS NOT MATING WITH THE DEVICE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20244539 ↗
• InjuryJul 10, 2023Unstable; Unstable

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 17292181 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT INITIAL KNEE REPLACEMENT. APPROXIMATELY 2 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS. IT WAS NOTED AS RESOLVED 2 WEEKS LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Ankylosis; Discomfort

  MAUDE report 16863169 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

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

  MAUDE report 16548083 ↗
• InjuryJun 6, 2022Material Erosion; Unstable; Adverse Event Without Identified Device or Use Problem; Material Erosion; Unstable; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD TKA WITH DR (B)(6) -STANDARD PRIMARY WITH CONE. SCREW BELOW IMPLANT THAT COULDN¿T BE REMOVED SO NO STEM USED. PATIENT HAD BECOME VERY UNSTABLE LATERALLY SO CAME FOR REVISION APPROXIMATELY 3 YEARS POST IMPLANTATION. ONCE OPENED UP WE FOUND POLY HAD BE SMASHED ON THE POSTERIOR MEDIAL CORNER. IT WAS HYPOTHESISED THAT MAYBE THE TIBIAL TRAY WAS KICKED INTO TOO MUCH EXTERNAL ROTATION WHICH CAUSED THE FEMUR TO CONTACT MORE POSTERIOR AND THE PATIENT MAY HAVE SUBLUXED POSTEROMEDIALLY. THERE WAS METALOSSIS IN THE JOINT FROM THE FEMUR RUBBING ON THE TIBIAL COMPONENT AS SEEN IN THE ATTACHED PICTURE OF EXPLANTED TIBIA. CONE WAS REMOVED AS WE COULDN¿T FIX ROTATION. COMPETITOR PRODUCT PERIMETER CONE USED WITH PRIMARY BASEPLATE AND STUBBY STEM AND ROTATION WAS CHANGED TO IMPROVE CONTACT POINT.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 14604231 ↗
• InjurySep 22, 2021Unstable; Unstable

  NO FURTHER EVENT INFORMATION AVAILABLE AT TIME OF THIS REPORT.

  Patient problems: Ambulation or Postural Difficulties; Numbness; Pain; Swelling/ Edema

  MAUDE report 12514542 ↗
• InjuryJan 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 11 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT A WASHOUT AND POLY EXCHANGE DUE TO INFECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 9574774 ↗
• InjuryDec 2, 2019Adverse 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: Unspecified Infection

  MAUDE report 9395099 ↗

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