PERSONA® Vivacit-E® 42-5221-003-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024468016), received between Feb 11, 2020 and Feb 2, 2026 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Unstable” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, ONE AND A HALF YEARS POST-IMPLANTATION, THE PATIENT CONTINUES TO EXPERIENCE PAIN AND SWELLING IN THE IMPLANTED JOINT. ADDITIONAL MEDICAL INTERVENTION HAS NOT BEEN REPORTED.

  Patient problems: Inflammation; Pain; Swelling/ Edema

  MAUDE report 24232785 ↗
• 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 KNEE ARTHROPLASTY REVISION OF THE ARTICULAR SURFACE TO ADDRESS STIFFNESS, RELEASE THE POSTERIOR LATERAL LIGAMENT AND DEBRIDE SCAR TISSUE APPROXIMATELY TWO (2) YEARS POST-OPERATIVELY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Arthrofibrosis; Loss of Range of Motion; Scar Tissue

  MAUDE report 22150064 ↗
• MalfunctionMar 19, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT SURGEON FOUND FOREIGN OBJECT ON STERILE IMPLANT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21646046 ↗
• InjuryOct 9, 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; Pain

  MAUDE report 20413299 ↗
• InjuryMay 31, 2023Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT HAD A TKA PROCEDURE PERFORMED. SUBSEQUENTLY, 2 YEARS, THREE MONTHS POST PROCEDURE THE ARTICULAR SURFACE WAS EXCHANGED DUE TO MILD INSTABILITY. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 17032350 ↗
• InjuryJan 19, 2023Unstable; Unstable

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

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Hyperextension; Joint Dislocation; Joint Laxity; Pain

  MAUDE report 16203757 ↗
• InjurySep 6, 2022Unstable; Unstable

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL KNEE PROCEDURE. SUBSEQUENTLY, 2 YEARS 7 MONTHS POST PROCEDURE, THE PATIENT HAS BEEN EXPERIENCING SEVERE PAIN ALL THE TIME, SWELLING, STINGING/BURNING SENSATION AROUND THE KNEE, LOSS OF BALANCE AND THE KNEE FEELS HEAVY LIKE THERE IS A WEIGHT AROUND THE KNEE WHEN WALKING.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 15365654 ↗
• InjuryFeb 14, 2022Adverse 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 ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION. THE POLYETHYLENE INSERT WAS EXCHANGED WITHOUT COMPLICATION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 13524137 ↗
• MalfunctionFeb 11, 2020Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9693368 ↗