PERSONA® Vivacit-E® 42-5221-007-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024468344), received between May 17, 2021 and Oct 27, 2025 — classified as 4 injuries.

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

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 27, 2025Adverse 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: Muscle/Tendon Damage

  MAUDE report 23392641 ↗
• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED PAIN, SWELLING AND SHIFTING OF KNEE POST IMPLANTATION. A POLY EXCHANGE WAS PERFORMED FOUR MONTHS AFTER THE INITIAL SURGERY WITH AN INCREASE IN SIZE OF THE POLY. PATIENT CONTINUES TO EXPERIENCE PAIN & SHIFTING POST REVISION.

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema

  MAUDE report 21365494 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT MANIPULATION UNDER ANESTHESIA AND ASPIRATION APPROXIMATELY FORTY-FIVE DAYS POST-IMPLANTATION DUE TO STIFFNESS. NO INFECTION WAS NOTED WITH THE KNEE ASPIRATION. NO FURTHER INTERVENTIONS HAVE BEEN REPORTED.

  Patient problems: Adhesion(s); Loss of Range of Motion; Scar Tissue

  MAUDE report 16456061 ↗
• InjuryMay 17, 2021Unstable; Unstable

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

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11839239 ↗