PERSONA® Vivacit-E® 42-5221-004-10 (UDI 00889024468092)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00889024468092), received between Feb 22, 2021 and Jun 23, 2026 — classified as 15 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A CLINICAL STUDY THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY ONE YEAR POST IMPLANTATION DUE TO INSTABILITY, HYPEREXTENSION, AND LATERAL PATELLAR PAIN DUE TO OSTEOPHYTE. DURING THE PROCEDURE THE PATELLAR OSTEOPHYTE WAS REMOVED. THE BEARING WAS UPSIZED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Exostosis (bone); Hyperextension; Joint Laxity; Pain

  MAUDE report 25596252 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA APPROXIMATELY ONE MONTH POST IMPLEMENTATION DUE TO LOSS OF RANGE OF MOTION AND PAIN. PATIENT CONTINUES TO BE DISSATISFIED WITH PAIN LEVEL. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 24209036 ↗
• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Erythema

  MAUDE report 22957327 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Hypoxia; Pulmonary Embolism; Tachycardia

  MAUDE report 22936274 ↗
• MalfunctionJul 28, 2025Break; Break

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

  Patient problems: Insufficient Information

  MAUDE report 22638482 ↗
• InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. FIVE DAYS LATER, THE PATIENT WAS HOSPITALIZED DUE TO A PULMONARY EMBOLISM. PATIENT WAS DISCHARGED APPROXIMATELY 10 DAYS LATER AND WAS REPORTED AS RESOLVED. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pulmonary Embolism

  MAUDE report 22149181 ↗
• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED PROGRESSIVE PERSISTENT PAIN AND WAS PRESCRIBED MEDICATION APPROXIMATELY TWO YEARS AND THREE MONTHS POST IMPLANTATION. THE PATIENT WAS PRESCRIBED MEDROL DOS PAK AND THE ISSUE RESOLVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 22131030 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY ONE (1) YEAR AND NINE (9) MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO INSTABILITY. ALL COMPONENTS WERE REVISED WITHOUT REPORTED COMPLICATION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity

  MAUDE report 21448654 ↗
• InjuryNov 15, 2024Naturally Worn; Naturally Worn

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

  Patient problems: Failure of Implant

  MAUDE report 20693454 ↗
• InjuryMay 21, 2024Fracture; Fracture

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

  Patient problems: Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 19361515 ↗
• InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA APPROXIMATELY TWO MONTHS POST IMPLANTATION DUE TO STIFFNESS AND LIMITED RANGE OF MOTION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 18239488 ↗
• InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Adhesion(s); Fall; Joint Laxity; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 17669694 ↗
• InjuryMay 20, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE IMPLANTED ARTICULAR SURFACE DISLOCATED POSTOPERATIVELY AND THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPLACE THE DISLOCATED IMPLANT APPROXIMATELY 23 DAYS LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 14455271 ↗
• InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Damage to Ligament(s); Fall

  MAUDE report 11968002 ↗
• MalfunctionMar 18, 2021Use of Device Problem; Use of Device Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11515183 ↗
• InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Loss of Range of Motion; Muscular Rigidity; Pain

  MAUDE report 11435877 ↗
• InjuryFeb 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED POST-OP STIFFNESS DUE TO LACK OF PHYSIOTHERAPY DUE TO COVID-19 RESTRICTIONS 6 MONTHS AFTER THE PROCEDURE. THE EVENT WAS RESOLVED 6 DAYS LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion; Muscular Rigidity; Scar Tissue

  MAUDE report 11357459 ↗