PERSONA® Vivacit-E® 42-5222-005-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024243033), received between Mar 19, 2024 and Dec 29, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TKA. SUBSEQUENTLY, PATIENT HAD THE FEMUR, AND POLY REVISED APPROXIMATELY 2 YEARS LATER DUE TO INSTABILITY AND PAIN. ATTEMPTS HAVE BEEN MADE, AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity

  MAUDE report 23906160 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE PROCEDURE. SUBSEQUENTLY THE PATIENT REQUIRED REVISION SURGERY DUE TO PAIN AND INSTABILITY. DURING THE REVISION THE ARTICULAR SURFACE WAS REPLACED. THE SURGICAL TECHNIQUE WAS UTILIZED. THE SURGEON STATED THE KNEE WAS THEN VERY STABLE. ALL THE AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22061727 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Insufficient Information

  MAUDE report 18991036 ↗
• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN, ARTHROFIBROSIS, STIFFNESS, LIMITED RANGE OF MOTION, RADIOLUCENCY AND TIBIAL AND FEMORAL IMPLANT LOOSENING APPROXIMATELY FIVE (5) YEARS FOLLOWING RIGHT KNEE ARTHROPLASTY. IN THE MONTHS AND YEARS FOLLOWING THE REVISION, THE PATIENT CONTINUED TO PROGRESS AND PAIN RESOLVED. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. REVISION OPERATIVE NOTES NOTED UNDER THE INDICATION FOR THE PROCEDURE, "THE PATIENT DID HAVE SEVERE ARTHROFIBROSIS WITH AN ARC OF MOTION OF ABOUT 40 DEGREES AS WELL AS RADIOGRAPHIC EVIDENCE OF LOOSENING OF BOTH [THE] FEMORAL AND TIBIAL COMPONENTS." DURING THE PROCEDURE, NOTES NOTED, "THERE WAS SEVERE ARTHROFIBROSIS THROUGHOUT THE ANTERIOR COMPARTMENT AS WELL AS MEDIAL AND LATERAL GUTTERS...NO BONE LOSS DURING REMOVAL OF [THE FEMORAL COMPONENT]...IT DID TAKE QUITE A BIT OF TIME TO EXPOSE THE TIBIAL COMPONENT SECONDARY TO [THE] SEVERE ARTHROFIBROSIS...THERE WERE NO FRACTURES ENCOUNTERED AND ABSOLUTELY NO BONE LOSS WAS ENCOUNTERED DURING TIBIAL COMPONENT REMOVAL." ALL COMPONENTS WERE REMOVED AND NO INTRAOPERATIVE COMPLICATIONS WERE NOTED.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 18932326 ↗
• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Adhesion(s); Scar Tissue

  MAUDE report 18928958 ↗

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