Persona® Vivacit-E® 42-5128-010-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024554580), received between Feb 21, 2022 and Feb 21, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Noise, Audible” (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.

• InjuryFeb 21, 2022Adverse Event Without Identified Device or Use Problem; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  IT WAS REPORTED THAT PATIENT HAD LEFT KNEE PAIN AND CREPITATION CONSISTENT WITH ARTHROFIBROSIS APPROXIMATELY SIXTEEN MONTHS POST-IMPLANTATION. THE PATIENT WAS SCHEDULED FOR AN ARTHROSCOPY AND DEBRIDEMENT BUT IT IS UNKNOWN IF IT HAS OCCURRED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Fibrosis; Pain

  MAUDE report 13567861 ↗

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: