Persona® 42-5603-135-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887868250019), received between Feb 21, 2022 and Mar 29, 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.

• InjuryMar 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT REPORTED COUGH, SHORTNESS OF BREATH, RIB PAIN, BACK PAIN, NAUSEA/VOMITING, AND DIARRHEA WHICH PROGRESSED TO DIFFICULTY BREATHING AND THE PATIENT WAS HOSPITALIZED APPROXIMATELY THREE WEEKS POST IMPLANTATION WITH PULMONARY EMBOLISM AND PNEUMONIA. THESE ISSUES WERE RESOLVED APPROXIMATELY SEVEN MONTHS LATER WITH MEDICAL TREATMENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Embolism/Embolus; Pneumonia

  MAUDE report 13942653 ↗
• InjuryFeb 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 11 WEEKS POST IMPLANTATION, THE PATIENT DEVELOPED SWELLING, INFLAMMATION, AND PES BURSITIS OF THE RIGHT KNEE. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH A CORTISONE INJECTION AND THE ISSUES RESOLVED. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Inflammation; Swelling/ Edema

  MAUDE report 13568795 ↗

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: