PERSONA® Vivacit-E® 42-5402-000-41Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024247727), received between Apr 18, 2023 and Feb 12, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

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

• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT PROCEDURE APPROXIMATELY TWO (2) WEEKS FOLLOWING RIGHT KNEE ARTHROPLASTY TO ADDRESS WOUND DEHISCENCE ACCOMPANIED BY ECCHYMOSIS AND MODERATE EFFUSION AS WELL AS REPAIR THE PATIENT'S QUADRICEP TENDON. DURING THE PROCEDURE, A SUBCUTANEOUS HEMATOMA WAS EVACUATED AND THE VASTUS MEDIALIS WAS CLOSED WITH ONE LOOP. NO IMPLANTS WERE REMOVED. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. IRRIGATION AND DEBRIDEMENT OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS.

  Patient problems: Ecchymosis; Hematoma; Joint effusion; Muscle/Tendon Damage; Pain; Wound Dehiscence

  MAUDE report 21366036 ↗
• InjuryMay 26, 2023Fracture; Fracture

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

  Patient problems: Failure of Implant; Pain; Radiolucent Lines; Swelling/ Edema

  MAUDE report 17012262 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS SCHEDULED TO UNDERGO A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS STIFFNESS, SWELLING, DISCOMFORT AND RECURRENT EFFUSIONS APPROXIMATELY FIVE YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Joint effusion; Swelling/ Edema

  MAUDE report 16763152 ↗

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