Persona® 42-5870-002-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024558878), received between Jan 10, 2023 and Sep 13, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED DURING KNEE ARTHROPLASTY THAT THE PIN COLD WELDED IN THE TIBIAL CUT GUIDE AND SUBSEQUENTLY FRACTURED. AS THE CUT HAD ALREADY BEEN COMPLETED, THE PROCEDURE WAS NOT IMPACTED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17737313 ↗
• MalfunctionJan 30, 2023Fracture; Mechanical Jam; Fracture; Mechanical Jam

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16265699 ↗
• MalfunctionJan 10, 2023Mechanical Jam; Mechanical Jam

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16130808 ↗

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: