PERSONA® Vivacit-E® 42-5121-008-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00889024469310), received between Feb 26, 2020 and Mar 19, 2026 — classified as 9 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A POLYETHYLENE INSERT EXCHANGE APPROXIMATELY 4 YEARS AND 5 MONTHS POST-IMPLANTATION DUE TO INSTABILITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity

  MAUDE report 24639157 ↗
• MalfunctionJul 1, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING THE TKA SURGERY, A 10MM SURFACE IMPLANT COULD NOT BE INSERTED EVEN AFTER SEVERAL ATTEMPTS WHILE PAYING ATTENTION TO THE INSERTION DIRECTION. AS A RESULT, THE SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER 10MM ARTICULAR SURFACE. ATTEMPTS HAVE BEEN MADE, AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22372657 ↗
• InjuryDec 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A KNEE REVISION DUE TO INSTABILITY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 21006321 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 2.5 MONTHS POSTOP, THE PATIENT EXPERIENCED THREE SYNCOPAL EPISODES AND RADIOGRAPHIC IMAGING CONFIRMED A PULMONARY EMBOLISM. THE PULMONARY EMBOLISM IS RESOLVING WITH PRESCRIBED MEDICATION AND ALL IMPLANTS REMAIN IN PLACE. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pulmonary Embolism; Syncope/Fainting

  MAUDE report 20137486 ↗
• InjuryJul 25, 2024Adverse 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

  MAUDE report 19832984 ↗
• InjuryMay 22, 2024Adverse 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: Adhesion(s); Loss of Range of Motion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 19373880 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 2 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA DUE TO MILD STIFFNESS/ARTHROFIBROSIS, MODERATE PAIN, AND DECREASED RANGE OF MOTION. UPON FOLLOW UP, THE PATIENT DEMONSTRATED SIGNIFICANT IMPROVEMENTS WITH PAIN AND FUNCTION WITH NO FURTHER COMPLICATIONS.

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

  MAUDE report 18468163 ↗
• InjuryAug 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN IN KNEE AND UNABLE TO STAND OR WALK FOR JUST A FEW MINUTES THREE YEARS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 17469693 ↗
• InjuryJun 26, 2023Unstable; Unstable

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

  Patient problems: Failure of Implant

  MAUDE report 17199840 ↗
• MalfunctionMay 2, 2023Fracture; Difficult to Insert; Fracture; Difficult to Insert

  IT WAS REPORTED THAT A TOTAL KNEE ARTHROPLASTY WAS PERFORMED. DURING THE OPERATION, THE SURGEON FAILED TO INSERT AN ARTICULAR SURFACE SEVERAL TIMES. HE REMOVED IT SEVERAL TIMES AND THE BACK SIDE ON THE ARTICULAR SURFACE BROKE. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16857202 ↗
• MalfunctionOct 13, 2022Difficult to Insert; Peeled/Delaminated; Difficult to Insert; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15599176 ↗
• InjuryOct 13, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

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

  Patient problems: Loss of Range of Motion

  MAUDE report 12628352 ↗
• MalfunctionFeb 26, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING THE INITIAL PROCEDURE, THE ARTICULAR SURFACE WOULD NOT SIT IN THE TIBIAL TRAY. AN ARTICULAR SURFACE IN THE NEXT SIZE UP WAS OPENED AND SUCCESSFULLY IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9753773 ↗