PERSONA® Vivacit-E® 42-5221-009-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00889024468504), received between Jan 8, 2020 and Sep 29, 2026 — classified as 10 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Joint Laxity; Pain

  MAUDE report 50934099 ↗
• MalfunctionFeb 12, 2026Positioning Failure

  IT WAS REPORTED THAT WHEN USING PERSONA OSSEOTI 0-DEGREE TIBIAL COMPONENT, THE ARTICULAR SURFACE DID NOT FIT. THERE WAS NO PATIENT IMPACT, SURGICAL TECHNIQUE UTILIZED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321618 ↗
• InjuryDec 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 23923375 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED WITH RANGE OF MOTION POSTOPERATIVELY ACHIEVED AT 0-130° WITH NO COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion

  MAUDE report 23906080 ↗
• MalfunctionDec 23, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING AN INITIAL TOTAL KNEE ARTHROPLASTY, THE ARTICULAR SURFACE WOULD NOT LOCK INTO THE TIBIAL TRAY. THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. IT WAS REPORTED THAT ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878999 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT¿S ARTICULAR SURFACE WAS REVISED APPROXIMATELY SEVEN MONTHS POST IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 23697085 ↗
• MalfunctionDec 2, 2025Positioning Failure; Positioning Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23696751 ↗
• MalfunctionJun 17, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED DURING KNEE ARTHROPLASTY THAT THE ARTICULAR SURFACE COULD NOT BE SEATED ON THE TIBIAL TRAY. ANOTHER ARTICULAR SURFACE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22229448 ↗
• InjurySep 15, 2023Unstable; Unstable

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

  Patient problems: Failure of Implant

  MAUDE report 17754648 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY WAS PERFORMED. SUBSEQUENTLY, APPROXIMATELY 2 MONTHS POST PROCEDURE, THE PATIENT HAD A PARTIAL WOUND DEHISCENCE, RESULTING IN EXTENSIVE WOUND CARE AND DELAYING FUNCTIONAL RECOVERY. THE PATIENT WAS PLACED ON RANGE OF MOTION RESTRICTIONS TO ALLOW WOUND HEALING. AFTER FULL HEALING OF THE WOUND OCCURRED, PHYSICAL THERAPY AND MANIPULATION OF THE JOINT RESUMED TO RESTORE FULL FUNCTION. THE PATIENT REMAINS SATISFIED WITH NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Loss of Range of Motion; Pain; Wound Dehiscence

  MAUDE report 17169701 ↗
• InjuryMay 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO INFECTION. THE ENTIRE CONSTRUCT WAS REMOVED AND REPLACED WITH ANTIBIOTIC SPACERS.

  Patient problems: Unspecified Infection

  MAUDE report 16904428 ↗
• InjuryMar 22, 2023Adverse 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 REVISION APPROXIMATELY 13 MONTHS POST IMPLANTATION DUE TO PAIN AND LOOSENING. THE TIBIAL COMPONENT AND ARTICULAR SURFACE WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 16590248 ↗
• MalfunctionOct 5, 2022Malposition of Device; Malposition of Device

  IT WAS REPORTED THE HCP ATTEMPTED TO IMPLANT THE BEARING, AFTER MULTIPLE TRIES REQUESTED A NEW BEARING. SECOND BEARING WAS ABLE TO BE SEATED SEAMLESSLY. NO DELAY, NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544971 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. IT WAS REPORTED THAT THE PATIENT DEVELOPED A DEEP VEIN THROMBOSIS APPROXIMATELY 3 DAYS POST IMPLANTATION. THE PATIENT WAS TREATED MEDICALLY AND ISSUE RESOLVED, WITH COMPONENTS REMAINING IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13595355 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 6 DAYS POST POLY REVISION, THE PATIENT WAS REVISED OF ALL COMPONENTS DUE TO INFECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 9564640 ↗