Persona® Vivacit-E® 42-5228-004-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024555051), received between May 25, 2022 and May 25, 2022 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K181947, K191625); 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.

• InjuryMay 25, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY WITH COMPETITOR PRODUCT. APPROXIMATELY 11 MONTHS POST OP, THE PATIENT WAS REVISED TO ZIMMER BIOMET PRODUCT. SUBSEQUENTLY, THE PATIENT WAS REVISED 1 YEAR LATER DUE TO A MECHANICAL FALL THAT CAUSED INSTABILITY, PATELLAR GRIND, PATELLAR MALTRACKING AND QUADRICEP RUPTURE. THE QUADRICEP MUSCLE AND VASTUS MEDIALIS WERE REPAIRED ALONG WITH THE POLYETHYLENE LINER EXCHANGED. THE PATELLA IS A COMPETITOR COMPONENT THAT REMAINED INTACT.

  Patient problems: Fall; Joint Laxity; Scar Tissue; Swelling/ Edema

  MAUDE report 14499380 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181947, K191625. One submission often covers many models, so check the product and lot details in each record.

• Z-2578-2026 · May 11, 2026 · Open, Classified
  Brand Name: Persona Revision Product Name: Persona Revision Trabecular Metal Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: