Persona® 42-5566-058-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024556799), received between Jun 19, 2024 and May 23, 2025 — classified as 5 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 5 most recent of 5 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 YEAR 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 22077609 ↗
• 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 22077598 ↗
• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS EXPERIENCING PAIN, ERYTHEMA, SWELLING, FEMORAL LOOSENING AND PERIPROSTHETIC, MEDIAL FEMORAL CONDYLE FRACTURE APPROXIMATELY FOUR YEARS POST IMPLANTATION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Erythema; Pain; Swelling/ Edema

  MAUDE report 21027279 ↗
• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS EXPERIENCING PAIN, ERYTHEMA, SWELLING, FEMORAL LOOSENING AND PERIPROSTHETIC, MEDIAL FEMORAL CONDYLE FRACTURE APPROXIMATELY FOUR YEARS POST IMPLANTATION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Erythema; Pain; Swelling/ Edema

  MAUDE report 21027272 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT WAS SEEN IN THE OFFICE ABOUT THREE YEARS POST IMPLANTATION AFTER SUBSEQUENT FALLS AND NOW EXPERIENCING PAIN AND A SIGNIFICANT EFFUSION. THE PATIENT HAS A FIVE DEGREE EXTENSOR LAG SECONDARY TO THE PAIN AND SWELLING AND AT THE OFFICE APPOINTMENT, AN ASPIRATION WAS PERFORMED. LIMITED BLOODY FLUID WAS COLLECTED AS IT WAS THOUGHT TO BE COAGULATED. ALL RADIOGRAPHIC IMAGING DISPLAYS IMPLANTS IN GOOD POSITION WITHOUT SIGNS OF GROSS FAILURE OR LOOSENING AND ALL IMPLANTS REMAIN IN PLACE.

  Patient problems: Fall; Hematoma; Joint effusion; Loss of Range of Motion; Pain

  MAUDE report 19567001 ↗

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: