Persona® Vivacit-E® 42-5228-007-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024555327), received between Feb 21, 2022 and Jun 19, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY TWO YEARS POSTOPERATIVELY DUE TO SCREW BACK-OUT. THERE WERE NO SURGICAL DELAYS AND NO FOREIGN BODIES WERE RETAINED. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Crepitus; Joint Laxity

  MAUDE report 22289530 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED TWO (2) FALLS APPROXIMATELY SEVENTEEN (17) MONTHS AND FORTY (40) MONTHS FOLLOWING A RIGHT KNEE ARTHROPLASTY. THE PATIENT WAS PRESCRIBED ANTI-INFLAMMATORIES AND REHABILITATION WAS RECOMMENDED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS.

  Patient problems: Fall; Pain

  MAUDE report 19721728 ↗
• 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 13568901 ↗

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: