PERSONA® Vivacit-E® 42-5221-008-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00889024468429), received between Apr 21, 2022 and Sep 24, 2026 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Packaging Problem

  It was reported the polyethylene insert packaging was warped, it is believed due to extreme heat. It was noticed during surgery, this device was not used, and a second poly was used instead, the surgical technique was utilized there was no surgical delay. Attempts have been made and no further information has been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885867 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION OF THE ARTICULAR SURFACE AND PATELLAR RESURFACING TO ADDRESS ANTERIOR KNEE PAIN SECONDARY TO PROGRESSION OF OSTEOARTHRITIS APPROXIMATELY THREE (3) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Arthritis; Insufficient Information; Pain

  MAUDE report 24345651 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 2 YEARS POST IMPLANTATION OF A RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT IS EXPERIENCING PAIN AND TIGHTNESS, AND HAS DIFFICULTY GOING UP STAIRS. SURGEON BELIEVES NO ALLEGATIONS AGAINST THE IMPLANT. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 23291555 ↗
• InjuryApr 21, 2025Adverse 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: Joint Laxity

  MAUDE report 21877164 ↗
• InjuryDec 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: Damage to Ligament(s); Joint Impingement; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 20884056 ↗
• InjuryAug 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: Joint Laxity

  MAUDE report 19949896 ↗
• MalfunctionJun 20, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE ARTICULAR SURFACE PROSTHESIS DOES NOT MATE CORRECTLY WITH DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19575967 ↗
• InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SURGERY. APPROXIMATELY ONE YEAR LATER, THE PATIENT WAS REVISED DUE TO LOOSENING, PAIN, AND INSTABILITY. DURING THE SURGERY, THE SURGEON ALSO NOTED THAT THE FEMORAL COMPONENT WAS INTERNALLY ROTATED AND OVERSIZED. ONLY THE TIBIAL COMPONENT AND POLY WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19172686 ↗
• InjuryApr 19, 2024Adverse 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. SUBSEQUENTLY, APPROXIMATELY TWO (2) MONTHS POST-IMPLANTATION, THE PATIENT EXHIBITED INADEQUATE FLEXION OF THE IMPLANTED JOINT. A MANIPULATION UNDER ANESTHESIA WAS PERFORMED WITHOUT COMPLICATION AND THE PATIENT'S RANGE OF MOTION IMPROVED. ALL DEVICES REMAIN IMPLANTED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 19143239 ↗
• MalfunctionApr 4, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT STAFF OPENED THE STERILE PACKAGE AND NOTICED A HAIR ON THE POLY. THAT IMPLANT WAS REMOVED FROM THE FIELD AND A NEW IMPLANT OF THE SAME SIZE WAS OPENED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19041014 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT PRESENTED TO HCP OFFICE WITH INSTABILITY ISSUES APPROXIMATLEY 6 MONTHS POST IMPLANTATION. THE TIBIAL IMPLANT AND ARTICULATING SURFACE WERE REVISED.

  Patient problems: Failure of Implant

  MAUDE report 17548339 ↗
• InjuryApr 21, 2022Material Erosion; Pitted; Material Erosion; Pitted

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY FOURTEEN MONTHS POST-IMPLANTATION DUE TO PAIN, LOOSENING, AND A TITANIUM ALLERGY. DURING THE REVISION, THE ARTICULAR SURFACE WAS FOUND TO PITTED AND BUBBLED.

  Patient problems: Failure of Implant

  MAUDE report 14166154 ↗