PERSONA® Vivacit-E® 42-5120-004-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00889024235045), received between Nov 24, 2021 and Oct 10, 2025 — classified as 7 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING THE SURGERY, AN ARTICULAR SURFACE WOULD NOT ASSEMBLE WITH THE TIBIAL TRAY EVEN AFTER SEVERAL ATTEMPTS WHILE PAYING ATTENTION TO THE INSERTION DIRECTION. AS A RESULT, ANOTHER ARTICULAR SURFACE WAS USED TO COMPLETE THE SURGERY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23265834 ↗
• InjuryJul 1, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING THE SURGERY, MULTIPLE ATTEMPTS WERE MADE TO INSERT A 10MM ARTICULAR SURFACE IMPLANT WHILE CAREFULLY MAINTAINING THE CORRECT INSERTION DIRECTION. DESPITE THESE EFFORTS, THE BACKSIDE OF THE IMPLANT BECAME DEFORMED, PREVENTING SUCCESSFUL PLACEMENT. ULTIMATELY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN ALTERNATIVE 10MM ARTICULAR SURFACE. ATTEMPTS HAVE BEEN MADE, AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22372429 ↗
• MalfunctionOct 23, 2024Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

  IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO INSERT THE CR ARTICULAR SURFACE TO TIBIA PLATE DURING A TOTAL KNEE ARTHROPLASTY SURGERY. THE SURGEON TRIED SEVERAL INSERTIONS AND A SECOND ARTICULAR SURFACE, BUT HE FAILED TO INSERT IT AGAIN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE THIRD ARTICULAR SURFACE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517742 ↗
• MalfunctionOct 23, 2024Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20516586 ↗
• InjuryOct 16, 2024Migration; Migration

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE THREE WEEKS POST IMPLANTATION DUE TO PATIENT KNEE SUBLUXING BACKWARDS. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Subluxation

  MAUDE report 20460151 ↗
• InjurySep 25, 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)

  MAUDE report 20301436 ↗
• MalfunctionSep 19, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE TIBIAL INSERT WOULD NOT SEAT IN THE TIBIAL TRAY. A SECOND TIBIAL INSERT WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20258711 ↗
• InjuryAug 27, 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: Pain; Radiolucent Lines

  MAUDE report 20075123 ↗
• InjuryAug 23, 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: Scar Tissue

  MAUDE report 20047931 ↗
• MalfunctionAug 13, 2024Difficult 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 19975730 ↗
• InjuryJul 9, 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: Loss of Range of Motion

  MAUDE report 19703861 ↗
• InjuryJan 3, 2024Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY 15 MONTHS POST IMPLANTATION DUE TO MOBILITY OF THE POSTERIOR TIBIAL COMPONENT. THE SURGEON ALLEGED THAT THE EXPLANTED ARTICULAR SURFACE WAS WORN. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Synovitis

  MAUDE report 18438578 ↗
• MalfunctionAug 24, 2023Difficult 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 17613719 ↗
• MalfunctionMar 31, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING KNEE ARTHROPLASTY THE SURGEON ATTEMPTED TO INSERT A 10MM ARTICULAR SURFACE ON THE TIBIAL BASE PLATE, HOWEVER, THE DEVICE WOULD NOT SEAT. THE SURGEON ATTEMPTED TO USE ANOTHER 10MM ARTICULAR SURFACE, HOWEVER, THE SAME ISSUE OCCURRED EVEN AFTER WASHING THE ARTICULAR SURFACES AND CHECKING THE TIBIAL BASE PLATE FOR SOFT TISSUE AND CEMENT. AN 11MM ARTICULAR SURFACE WAS OPENED AND USED WITHOUT ISSUE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13969536 ↗
• MalfunctionMar 31, 2022Difficult 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 13969460 ↗
• MalfunctionNov 24, 2021Positioning Failure; Positioning Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12870617 ↗

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