Persona® Vivacit-E® 42-5128-007-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024554337), received between Apr 23, 2024 and Jun 19, 2024 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT BEGAN TO EXPERIENCE AN INCREASE IN PAIN APPROXIMATELY 8 MONTHS POST PROCEDURE. THE PATIENT WAS PRESCRIBED A MEDROL PACK AND AN ADDITIONAL COURSE OF PHYSICAL THERAPY. THE PAIN IMPROVED BUT RETURNED AROUND 2 WEEKS LATER WHERE IT WAS PRESENTED OVER THE LCL AND A GENICULAR BLOCK WAS RECOMMENDED. ALL RADIOGRAPHIC IMAGING DISPLAYS IMPLANTS IN GOOD POSITION WITHOUT GROSS FAILURE OR LOOSENING AND ALL IMPLANTS REMAIN IN PLACE.

  Patient problems: Pain

  MAUDE report 19567584 ↗
• InjuryApr 23, 2024Unstable; Unstable

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

  Patient problems: Joint Laxity; Pain

  MAUDE report 19167341 ↗

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: