PERSONA® Vivacit-E® 42-5221-007-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024468351), received between Sep 30, 2021 and Aug 4, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2026Unsealed Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50133626 ↗
• InjuryApr 29, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY 3 YEARS AND 3 MONTHS POST-IMPLANTATION DUE TO PATELLA BUTTON LOOSENING. DURING THE REVISION, MODERATE SYNOVITIS AND SCAR TISSUE WERE REMOVED. THE POLYETHYLENE INSERT WAS NOTED TO BE THINNER THAN NECESSARY AND A THICKER INSERT WAS SELECTED TO ADDRESS RECURVATUM AND MILD LAXITY. THE UNDERSURFACE OF THE PATELLA WAS OBSERVED TO BE FRACTURED, AND THE PATELLA BUTTON AND POLYETHYLENE INSERT WERE EXCHANGED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain; Scar Tissue; Synovitis

  MAUDE report 25035839 ↗
• InjuryDec 31, 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: Insufficient Information; Joint Laxity

  MAUDE report 21048810 ↗
• InjurySep 23, 2024Adverse 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: Joint Laxity

  MAUDE report 20286632 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Insufficient Information

  MAUDE report 19234550 ↗
• InjurySep 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE MANIPULATION UNDER ANESTHESIA TO ADDRESS POST-OPERATIVE PAIN AND STIFFNESS APPROXIMATELY FOUR (4) MONTHS POST-OPERATIVELY. INITIAL OPERATIVE NOTES DID NOT IDENTIFY ANY INTRAOPERATIVE COMPLICATIONS. AT THE PATIENT'S 3-MONTH POST-OPERATIVE VISIT, THE PATIENT WAS STRUGGLING WITH ANTERIOR KNEE DISCOMFORT, CLICKING SOUNDS IN THE KNEE AND LIMITED RANGE OF MOTION. MANIPULATION OPERATIVE NOTES NOTED RELEASE OF ADHESIONS WITHOUT ANY INTRAOPERATIVE COMPLICATIONS.

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

  MAUDE report 12556246 ↗