Persona® 42-5420-064-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024562868), received between Jun 13, 2022 and May 23, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT REPORTED MODERATE PAIN TO THE KNEE WITH EXTREME PAIN STANDING UPRIGHT AND BENDING TO THE FLOOR DURING THE TWO YEARS FOLLOW UP. THE PATIENT HAS IMPROVED AS THE STUDY CONTINUED, ALL RADIOGRAPHIC IMAGING DISPLAYS NO SIGNIFICANT FINDINGS, AND ALL PRODUCTS REMAIN IMPLANTED.

  Patient problems: Pain

  MAUDE report 22077611 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT IS EXPERIENCING PAIN APPROXIMATELY TWO YEARS POST IMPLANTATION. ALL RADIOGRAPHIC IMAGING DISPLAYS NO SIGNIFICANT FINDINGS AND ALL PRODUCTS REMAIN IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 22072819 ↗
• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Fall; Pain

  MAUDE report 19697322 ↗
• InjuryJun 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT IS BEING CONSIDERED FOR A REVISION ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14678714 ↗

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: