PERSONA® Vivacit-E® 42-5221-008-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024468467), received between Oct 5, 2023 and Mar 30, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A PRIMARY KNEE SURGERY. SUBSEQUENTLY ABOUT 6 MONTHS LATER, THEY HAD A REVISION DUE TO EXTENSION LAXITY. THE SURGICAL TECHNIQUE WAS UTILIZED; THERE WAS NO SURGICAL DELAY OR FOREIGN BODIES RETAINED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity

  MAUDE report 24714565 ↗
• InjuryOct 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. DURING THE POST-OP CONSULT, THE SURGEON NOTED THAT THERE WAS A SMALL FLEXION DEFORMITY OF APPROXIMATELY 5 DEGREES AND CT IMAGING REVEALED THAT THE POLY WAS NOT FIXED TO THE BASEPLATE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 2 MONTHS POST-OP. THE POLY WAS REVISED TO A LARGER POLY. IT WAS NOTED THAT THE SURGEON SPENT A CONSIDERABLE AMOUNT OF TIME REMOVING SOFT TISSUE AND BONE FROM THE POSTERIOR TIBIA, HOWEVER, THERE WAS NO SURGICAL DELAY. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion

  MAUDE report 23336166 ↗
• InjuryJan 9, 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: Damage to Ligament(s); Joint Laxity

  MAUDE report 18474586 ↗
• MalfunctionOct 5, 2023Difficult to Insert; Difficult to Insert

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17878530 ↗