PERSONA® Vivacit-E® 42-5224-005-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024243606), received between Feb 21, 2022 and Mar 17, 2025 — classified as 1 injury, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED DURING KNEE ARTHROPLASTY WHILE THE SURGEON ATTEMPTED TO INSERT THE ARTICULAR SURFACE, THERE WAS A SMALL GAP BETWEEN THE INSERT AND THE TOP OF THE TIBIAL BASEPLATE AFTER SEVERAL ATTEMPTS TO SEAT THE DEVICE. ANOTHER ARTICULAR SURFACE WAS OPENED, HOWEVER, THE SURGEON STRUGGLED TO SEAT THE SECOND IMPLANT AS WELL. THE SECOND ARTICULAR SURFACE IMPLANT WAS IMPACTED APPROXIMATELY FIVE (5) TIMES ANTERIORLY WITH A TIBIAL PROVISIONAL EXTRACTOR BEFORE IT WAS SUCCESSFULLY SEATED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21623981 ↗
• MalfunctionMar 17, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED DURING KNEE ARTHROPLASTY WHILE THE SURGEON ATTEMPTED TO INSERT THE ARTICULAR SURFACE, THERE WAS A SMALL GAP BETWEEN THE INSERT AND THE TOP OF THE TIBIAL BASEPLATE AFTER SEVERAL ATTEMPTS TO SEAT THE DEVICE. ANOTHER ARTICULAR SURFACE WAS OPENED, HOWEVER, THE SURGEON STRUGGLED TO SEAT THE SECOND IMPLANT AS WELL. THE SECOND ARTICULAR SURFACE IMPLANT WAS IMPACTED APPROXIMATELY FIVE (5) TIMES ANTERIORLY WITH A TIBIAL PROVISIONAL EXTRACTOR BEFORE IT WAS SUCCESSFULLY SEATED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21623961 ↗
• InjuryFeb 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE FIVE YEARS POST IMPLANTATION DUE TO DUE TO ARTHROFIBROSIS AND PAIN. DURING THE REVISION DENSE SCARRING WAS FOUND THROUGHOUT THE KNEE AND FLEXION AND EXTENSION MISMATCH. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Pain; Scar Tissue

  MAUDE report 13584271 ↗
• MalfunctionFeb 21, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN INITIAL TOTAL KNEE ARTHROPLASTY, THE TIBIAL INSERT WOULD NOT SEAT ON THE TIBIAL TRAY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13567898 ↗

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