Persona® 42-5046-054-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024562516), received between Apr 27, 2022 and Apr 27, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (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.

• MalfunctionApr 27, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A REVISION PROCEDURE, THE SURGEON MISTAKENLY OPENED LEFT IMPLANTS WHICH WERE IMPLANTED INTO THE PATIENT. THE ERROR WAS NOTICED AFTER IMPACTING THE COMPONENTS. ALL COMPONENTS WERE REMOVED WITHOUT ADDITIONAL BONE LOSS OR COMPLICATIONS, AND THE CORRECT RIGHT SIDED IMPLANTS WERE PLACED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14220842 ↗

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: