PERSONA® Vivacit-E® 42-5120-005-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024235151), received between Nov 12, 2024 and Aug 28, 2026 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent an initial left total knee arthroplasty. Subsequently, the patient reported lateral knee pain with occasional swelling approximately 2 years post-op. Lucency was noted on CT scan. Physical therapy was prescribed. Attempts have been made and all available information has been provided.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 50495785 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REPORTED PAIN AND SWELLING WITH SLIGHT WARMNESS IN THEIR CALF ON APPROXIMATELY 8 DAYS POST-OP. A DOPPLER WAS PERFORMED THAT CONFIRMED THE PATIENT WAS POSITIVE FOR A LOWER LEG DVT IN THE POSTERIOR TIBIAL VEIN AND HEMATOMA IN THE CALF. THE PATIENT WAS PRESCRIBED BABY ASPIRIN. THE PATIENT THEN PRESENTED TO THE ER AND WAS PRESCRIBED AN ELIQUIS STARTER PACK FOR THE DISTAL DVT. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Hematoma; Pain; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 20664795 ↗

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