PERSONA® Vivacit-E® 42-5221-009-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024468528), received between May 28, 2020 and May 13, 2025 — classified as 3 injuries, 3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 5 WEEKS POST-OP, THE PATIENT BEGAN TO EXPERIENCE SEVERE PAIN APPROXIMATELY. AT THE NINE MONTH POST-OP FOLLOW-UP APPOINTMENT, THE PATIENT REPORTED SEVERE PAIN AND DIFFICULTIES WITH AMBULATION AND ADLS. ALL RADIOGRAPHIC IMAGING DISPLAYED NO SIGNIFICANT FINDINGS AND THE KNEE WAS STABLE UPON ASSESSMENT. A BRACE WAS GIVEN AT THE 9 MONTH FOLLOW-UP TO RULE OUT ANY INSTABILITY THAT COULD BE CONTRIBUTING TO THE ONGOING PAIN. ALL PRODUCTS REMAIN IMPLANTED. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 22009043 ↗
• InjuryMay 7, 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: Ambulation or Postural Difficulties

  MAUDE report 19260213 ↗
• MalfunctionSep 1, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THE SURGEON NOTICED A HAIR WHEN HE HAD THE POLY ON THE TIBIA MID SURGERY. ONCE IT WAS REALIZED THERE WAS A HAIR ON IT HE DISCARDED THE POLY WITH THE HAIR ON IT AS A PRECAUTION. A SECOND IMPLANT WAS USED TO COMPLETE THE SURGERY. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17670239 ↗
• MalfunctionMay 31, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE POLY WOULD NOT ENGAGE AND LOCK INTO PLACE. A SECOND POLY WAS OPENED AND CLICKED RIGHT IN. IT WAS NOTED THAT THE SURGEON TRIED TO INSERT THE FIRST POLY WITHOUT CLEANING THE TRAY OUT FIRST. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14549955 ↗
• MalfunctionNov 23, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A REVISION OF COMPETITOR PRODUCTS THAT THE POLY WOULD NOT SEAT INTO THE TIBIA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10884570 ↗
• InjuryMay 28, 2020Adverse 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 UNILATERAL TOTAL KNEE ARTHROPLASTY ON AND SUBSEQUENTLY, THE PATIENT DEVELOPED A RIGHT LOWER EXTREMITY DVT APPROXIMATELY ONE WEEK LATER, REQUIRING AN UNKNOWN MEDICAL INTERVENTION. THE DVT WAS RESOLVED APPROXIMATELY ONE MONTH LATER.

  Patient problems: Embolism

  MAUDE report 10098481 ↗