PERSONA® Vivacit-E® 42-5124-004-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024237056), received between Mar 21, 2024 and Mar 21, 2024 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION OF THE ARTICULAR SURFACE TO ADDRESS PAIN, INSTABILITY, SWELLING AND EFFUSIONS APPROXIMATELY THREE (3) YEARS FOLLOWING THE PATIENT'S LAST KNEE PROCEDURE. DURING THE REVISION, SIGNIFICANT SCAR TISSUE WAS IDENTIFIED. THE ARTICULAR SURFACE WAS EXCHANGED FOR A LARGER SIZE AND THE SURGERY WAS COMPLETED WITHOUT COMPLICATION. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. REVISION OPERATIVE NOTES NOTED THAT THE PATIENT WAS BEING REVISED FOR INCREASING GLOBAL INSTABILITY OVER THE PREVIOUS SIX (6) TO NINE (9) MONTHS. UPON EXAMINATION, THE PATIENT HAD ABOUT FIVE (5) DEGREES OF RECURVATUM AND SIGNIFICANT INSTABILITY AT TERMINAL EXTENSION WITH ABOUT ONE (1) CENTIMETER OF CORONAL PLANE INSTABILITY. DURING THE PROCEDURE, SIGNIFICANT SCAR AND FIBROTIC TISSUE WAS DEBRIDED. ALL IMPLANTS WERE EXAMINED AND APPEARED STABLE AND THE ARTICULAR SURFACE WAS REPLACED WITH A LARGER SIZE WITH NO INTRAOPERATIVE COMPLICATIONS NOTED.

  Patient problems: Joint Laxity; Joint effusion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 18948830 ↗

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