Persona® Vivacit-E® 42-5128-007-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024554313), received between Feb 13, 2023 and Oct 30, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Positioning Failure” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2024Positioning Failure; Positioning Failure

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570895 ↗
• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN AND DIAGNOSED WITH SYNOVITIS THREE MONTHS POST IMPLANTATION. IT WAS NOTED THAT THERE WAS A COMPLEX PRIMARY TKA UTILIZING REVISION COMPONENTS WITH STEMS AND SEMI CONSTRAINED LINER, MAC PLUS SPINAL AND NERVE BLOCK, CLEAR YELLOW SYNOVIAL FLUID, EXTENSIVE SCAR TISSUE THROUGH THE SUPRAPATELLAR POUCH AND GUTTERS AND ANTERIORLY. ADDITIONAL 4MM BONE CUT ON THE DISTAL FEMUR DUE TO FLEXION CONTRACTURE, AREA ON NONUNION WHERE TIBIA HAD COLLAPSED MEDIALLY THIS WAS EXCISED AS WELL AS SCAR TISSUE, SURGEON DETERMINED IT WOULD BE MORE BENEFICIAL TO THE PATIENT TO GO FROM PRIMARY KNEE TO A SEMI CONSTRAINED COMPONENT TO ALLOW FOR BETTER STABILITY, GOOD ROM AND STABILITY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Pain; Synovitis

  MAUDE report 16368399 ↗

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: