PERSONA® Vivacit-E® 42-5224-004-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024243514), received between Oct 11, 2021 and May 3, 2024 — classified as 1 injury, 2 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY THE 10MM ARTICULAR SURFACE DIDN'T MATE WITH TIBIAL PLATE. THERE WAS NO INTERFERENCE OF SOFT TISSUE, BONE SPUR OR CEMENT PARTICLES. THE SURGEON TRIED THE SEVERAL INSERTIONS, BUT THE ARTICULAR SURFACE DIDN'T MATE. AS A RESULT, THE OPERATION WAS COMPLETED WITH ANOTHER 10MM ARTICULAR SURFACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19237266 ↗
• MalfunctionMay 11, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE TIBIAL INSERT WOULD NOT SEAT ON THE TIBIAL TRAY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14353678 ↗
• InjuryOct 11, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

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

  Patient problems: Ambulation or Postural Difficulties; Hematoma; Loss of Range of Motion; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 12605548 ↗

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