Persona® 42-5603-135-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887868250040), received between Feb 16, 2022 and Mar 28, 2025 — classified as 2 injuries.

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.

• InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD A HEMATOMA EVACUATED APPROXIMATELY TWO WEEKS POST PROCEDURE. A SIGNIFICANT HEMATOMA WAS NOTED, EVACUATED, AND A DRAIN PLACED. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED.

  Patient problems: Hematoma

  MAUDE report 21719913 ↗
• InjuryFeb 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A CLINICAL STUDY THAT A PATIENT UNDERWENT A LEFT REVISION PROCEDURE APPROXIMATELY TWO YEARS POST IMPLANTATION DUE SEVERE PAIN WITH TWISTING OR STAIRS AND MODERATE PAIN WITH PATELLAR TENDONITIS. THE PATIENT WAS TREATED WITH A TOPICAL ANTI-INFLAMMATORY CREAM AND THE OUTCOME WAS REPORTED AS RESOLVED ON THE SAME DAY. THE PRODUCTS REMAIN IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Inflammation; Pain

  MAUDE report 13546117 ↗

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: