Persona® 42-5603-135-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887868250057), received between Feb 17, 2022 and Jul 13, 2022 — 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.

• InjuryJul 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE DAY FOLLOWING RIGHT KNEE ARTHROPLASTY, IT WAS IDENTIFIED THAT THE PATIENT HAD EXPERIENCED A TIBIAL SHAFT FRACTURE DURING IMPLANTATION OF THE TIBIAL STEM AFTER REVIEWING POST-OPERATIVE X-RAYS. THE PATIENT WAS PLACED ON NON-WEIGHTBEARING RESTRICTIONS AND ADVISED TO UTILIZE A WALKING BOOT FOR STABILIZATION WITH CONTINUED PHYSICAL THERAPY. THE FRACTURE HEALED WITHIN A FEW MONTHS. OPERATIVE NOTES FROM THE PROCEDURE NOTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT ACHIEVED FULL RANGE OF MOTION AND GOOD STABILITY WITH PLACED COMPONENTS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Bone Fracture(s); Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 15002637 ↗
• InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED MODERATE L PES ANSERINE BURSITIS APPROXIMATELY EIGHT MONTHS POST IMPLANTATION. THE PATIENT WAS GIVEN CORTISONE INJECTIONS AND THE ISSUE RESOLVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Inflammation; Pain; Swelling/ Edema

  MAUDE report 13548361 ↗

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: