PERSONA® Vivacit-E® 42-5121-007-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024469259), received between Jan 5, 2022 and Mar 11, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

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 11, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION OF THE ARTICULAR SURFACE TO ADDRESS PAIN, SWELLING AND INSTABILITY THAT WAS INTERFERING WITH RANGE OF MOTION APPROXIMATELY ONE YEAR POST-OPERATIVELY. THE SURGEON REPORTED THAT THE TIBIAL ROTATION DID NOT MATCH THE CORRECT PLACEMENT FOR A MEDIAL CONGRUENT BEARING AS THE SOFT TISSUES WERE TOO TIGHT TO ALLOW COMPONENT ARTICULATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Joint effusion; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 18882009 ↗
• MalfunctionJan 5, 2022Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

  IT WAS REPORTED THAT AN ARTICULAR SURFACE WAS NOT SEATING TO THE TIBIAL TRAY. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13172127 ↗