PERSONA® Vivacit-E® 42-5121-009-11 (UDI 00889024469389)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024469389), received between Jan 3, 2024 and Mar 11, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2025Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21571974 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO AN INFECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 21060553 ↗
• MalfunctionOct 10, 2024Difficult to Insert; Difficult to Insert

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20416970 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ACUTE INFECTION TKP LET WITH HEMOLYTIC STREPTOCOCCUS GROUP G, THAT LED TO HOSPITALIZATION OF PATIENT WITH IV ANTIBIOTIC TREATMENT (AMOXICILLINE IV AND CLINDAMYCIN). THE COMPLICATION WAS RESOLVED 4 MONTHS AFTER DATE OF OCCURRENCE, KNEE IS NOW DOING WELL, NO SYMPTOMS, NO SICKNESS, NO SIGNS OF INFECTION, AND TREATMENT HAS THEREFORE BEEN CONCLUDED.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 18440106 ↗