PERSONA® Vivacit-E® 42-5220-005-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00889024241626), received between Nov 3, 2021 and Jul 29, 2026 — classified as 11 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K121771, K172524); they may or may not involve this specific model.

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2026Delivered as Unsterile Product

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50072276 ↗
• InjuryMar 23, 2026Adverse 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 Laxity

  MAUDE report 24662000 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A KNEE POLYETHYLENE INSERT EXCHANGE FROM CR TO MC APPROXIMATELY 2 YEARS AND 11 MONTHS POST-IMPLANTATION DUE TO A FALL WITH ONGOING PAIN AND LAXITY IN THE KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 24331594 ↗
• MalfunctionDec 2, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DESPITE MULTIPLE ATTEMPTS TO INSERT THE ARTICULAR SURFACE IMPLANT WHILE CAREFULLY NOTING THE INSERTION DIRECTION, IT WOULD NOT SEAT. UPON CHECKING THE SHAPE OF THE SURFACE, IT APPEARED THAT IT HAD BECOME DEFORMED. THEREFORE, A NEW IMPLANT OF THE SAME SIZE WAS OPENED AND USED INSTEAD. THERE WAS NO PATIENT INJURY AS A RESULT OF THE MALFUNCTION. 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 23693389 ↗
• InjuryNov 24, 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 Contracture

  MAUDE report 23632491 ↗
• InjuryNov 24, 2025Adverse 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 ARTHROPLASTY REVISION OF THE ARTICULAR SURFACE WITH DEBRIDEMENT TO ADDRESS PAIN APPROXIMATELY NINE (9) MONTHS POST-OPERATIVELY.ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 23632058 ↗
• MalfunctionNov 17, 2025Positioning Failure; Device-Device Incompatibility; Material Deformation; Positioning Failure; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CR SURFACE IMPLANT 10 MM COULD NOT BE INSERTED DESPITE MULTIPLE ATTEMPTS WHILE CAREFULLY CONSIDERING THE INSERTION DIRECTION. AFTER REPEATED INSERTION ATTEMPTS FAILED, THE SHAPE OF THE SURFACE WAS INSPECTED AND NOTED TO BE DEFORMED. THE AFFECTED DEVICE WAS NOT IMPLANTED, AND A NEW, UNUSED 10 MM IMPLANT WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY OF APPROXIMATELY 10 MINUTES. THERE WERE NO KNOWN CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23572774 ↗
• MalfunctionJul 3, 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 22396514 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A KNEE REVISION SURGERY APPROXIMATELY ELEVEN MONTHS POST IMPLANTATION DUE TO STIFFNESS CONSISTING OF EXCISION OF SCAR TISSUE AND EXCHANGE OF THE ARTICULAR SURFACE.

  Patient problems: Scar Tissue

  MAUDE report 22077589 ↗
• InjuryMar 24, 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: Insufficient Information

  MAUDE report 21677232 ↗
• MalfunctionNov 15, 2024Positioning Failure; Positioning Failure

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695446 ↗
• InjuryNov 11, 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

  MAUDE report 20651885 ↗
• InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY TWO MONTHS POST-IMPLANTATION DUE TO STIFFNESS AND DECREASED RANGE OF MOTION. THE FEMORAL AND TIBIAL INSERT WERE REMOVED AND REPLACED.

  Patient problems: Loss of Range of Motion

  MAUDE report 19336695 ↗
• InjuryMar 29, 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 KNEE SURGERY AND APPROXIMATELY 11 MONTHS LATER, THE PATIENT WAS REVISED DUE TO ARTHROFIBROSIS. THE TIBIAL COMPONENT AND POLY WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Fibrosis

  MAUDE report 19003343 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE FIVE MONTHS POST IMPLANTATION DUE TO STIFFNESS AND RANGE OF MOTION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 16852570 ↗
• InjuryJan 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 22 MONTHS POST IMPLANTATION DUE TO IMPLANT FRACTURE AND POSSIBLE INFECTION. DURING THE SURGERY, THE SURGEON FOUND THAT THE MEDIAL POSTERIOR ON THE REMOVED ARTICULAR SURFACE WAS CHIPPED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 13169659 ↗
• MalfunctionNov 3, 2021Difficult to Insert; Difficult to Insert

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12746178 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121771, K172524. One submission often covers many models, so check the product and lot details in each record.

• Z-1917-2016 · May 11, 2016 · Terminated
  Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.
• Z-1266-2015 · Jan 28, 2015 · Terminated
  Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer For use in eit