Persona® Vivacit-E® 42-5228-004-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024555075), received between Jan 13, 2021 and Nov 19, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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.

• InjuryNov 19, 2024Fracture; Fracture

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

  Patient problems: Failure of Implant

  MAUDE report 20724492 ↗
• MalfunctionJan 13, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THE PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED A TRAUMATIC ACCIDENT RESULTING IN A LOOSE TIBIA. THE PATIENT WAS REVISED DUE TO TIBIA LOOSENING APPROXIMATELY 4 YEARS POST IMPLANTATION. DURING THE REVISION PROCEDURE, THE SURGEON HAD DIFFICULTY INSERTING THE ARTICULAR SURFACE. ANOTHER ARTICULAR SURFACE WAS USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11165118 ↗

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: