PERSONA® Vivacit-E® 42-5221-004-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024468115), received between Feb 7, 2020 and Sep 29, 2026 — classified as 8 injuries, 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Fracture

  Patient problems: Pain

  MAUDE report 50932078 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN AND INSTABILITY APPROXIMATELY TWO (2) YEARS POST-OPERATIVELY. THE ARTICULAR SURFACE WAS UPSIZED AND THE PATELLA WAS REVISED AND RESURFACED. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23449694 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS SCHEDULED TO UNDERGO A PLANNED REVISION APPROXIMATELY TWO (2) YEARS AND ONE (1) MONTH POST-IMPLANTATION DUE TO INSTABILITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 20683376 ↗
• MalfunctionNov 13, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED DURING KNEE ARTHROPLASTY THAT THE ARTICULAR SURFACE COULD NOT BE SEATED IN THE PROPER POSITION ON THE TIBIAL TRAY. AS A RESULT, ANOTHER ARTICULAR SURFACE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678234 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY HAD A MANIPULATION UNDER ANESTHESIA TWO MONTHS POST PROCEDURE DUE TO STIFFNESS. COMPONENTS REMAIN IMPLANTED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Loss of Range of Motion

  MAUDE report 14073730 ↗
• InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT HAD A MANIPULATION UNDER ANESTHESIA DUE TO STIFFNESS AND ARTHROFIBROSIS IN KNEE FIFTY FIVE DAYS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

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

  MAUDE report 13618642 ↗
• InjuryNov 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT REPORTED EXPERIENCING PAIN AND INFLAMMATION IN THE KNEE APPROXIMATELY ONE YEAR POST-IMPLANTATION. A STEROID INJECTION WAS GIVEN IN THE KNEE DUE TO IMPINGEMENT OF THE FEMORAL IMPLANT ON THE IT BAND DUE TO OVERHANG. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Inflammation; Pain

  MAUDE report 12738392 ↗
• InjuryAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL RIGHT UNILATERAL KNEE SURGERY. APPROXIMATELY 24 DAYS POST IMPLANTATION, THE PATIENT EXPERIENCED A PULMONARY EMBOLISM WHICH REQUIRED HOSPITALIZATION FOR 8 DAYS.

  Patient problems: Pulmonary Embolism

  MAUDE report 10472434 ↗
• InjuryFeb 7, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 2 MONTHS POST IMPLANTATION, THE PATIENT WAS EXPERIENCING STIFFNESS AND CONSEQUENTLY UNDERWENT A MANIPULATION UNDER ANESTHESIA WITH INJECTION OF THE RIGHT KNEE. APPROXIMATELY 2 WEEKS POST MANIPULATION, THE PATIENT'S SWELLING HAD REPORTEDLY RESOLVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 9681151 ↗