Persona® 42-5046-066-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024562721), received between Mar 24, 2023 and Sep 16, 2026 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient hyperextended the right knee and reported swelling and pain about three months post implantation. Approximately two and half year's post implantation the patient complained of moderate pain and refused x-rays. Three years and three months after the patient refused x-rays, a right open lysis of adhesions with possible lateral release and polyethylene exchange due to arthrofibrosis was ordered. No further information provided.

  Patient problems: Arthrofibrosis; Hyperextension; Pain; Swelling/ Edema

  MAUDE report 50792570 ↗
• InjuryApr 16, 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: Ambulation or Postural Difficulties; Joint Contracture; Pain

  MAUDE report 19119333 ↗
• InjuryApr 12, 2023Adverse 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: Muscular Rigidity

  MAUDE report 16724667 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A RIGHT KNEE ARTHROPLASTY REVISION TO INCREASE STABILITY DUE TO FLEXION LAXITY AND CONSTANT PAIN APPROXIMATELY THREE (3) YEARS POST-OPERATIVELY. THE PATIENT HAS BEEN PRESCRIBED ULTRAM FOR PAIN MANAGEMENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain

  MAUDE report 16609446 ↗

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: