PERSONA® Vivacit-E® 42-5120-005-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00889024235113), received between Mar 18, 2020 and Mar 9, 2026 — classified as 7 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Difficult to Insert

  IT WAS REPORTED DURING KNEE ARTHROPLASTY THAT WHEN THE SURGEON WAS ATTEMPTING TO LOCK THE ARTICULAR SURFACE INTO THE TIBIAL TRAY, THE ARTICULAR SURFACE COULD NOT BE SEATED. THE SURGEON ENSURED SIZING WAS APPROPRIATE, TECHNIQUE WAS CORRECT AND THAT THERE WAS NO SOFT TISSUE OR FOREIGN DEBRIS IMPEDING THE FIT OF THE IMPLANT. ANOTHER ARTICULAR SURFACE WAS OPENED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24546103 ↗
• MalfunctionDec 4, 2025Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720335 ↗
• InjuryOct 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: Pain

  MAUDE report 20407692 ↗
• InjuryJul 2, 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 LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY TWO (2) YEARS AND ONE (1) MONTH POST-IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE LIMITED RANGE OF MOTION AND WAS UNABLE TO BEND THE IMPLANTED KNEE PAST 90 DEGREES AND USE STAIRS. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY. THE TIBIAL COMPONENT, ARTICULAR SURFACE, AND IMPLANTED PATELLA WERE REPLACED WITHOUT REPORTED COMPLICATION. ALL AVAILABLE INFORMATION HAS BEEN REPORTED.

  Patient problems: Loss of Range of Motion

  MAUDE report 19658107 ↗
• InjuryDec 20, 2023Adverse 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: Inflammation; Joint Laxity

  MAUDE report 18367379 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION APPROXIMATELY SIX (6) YEARS POST-OPERATIVELY TO ADDRESS PAIN AND MILD TIBIAL AND FEMORAL IMPLANT LOOSENING. DURING THE REVISION, HOWEVER, THE IMPLANTS WERE NOTED TO BE WELL-FIXED, AND THE SURGEON STRUGGLED TO REMOVE THEM. ALL COMPONENTS WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 17312436 ↗
• MalfunctionJul 14, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A KNEE ARTHROPLASTY REVISION, THE ARTICULAR SURFACE WOULD NOT ENGAGE WITH THE TIBIAL PLATE AFTER SEVERAL ATTEMPTS. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15016924 ↗
• MalfunctionJan 24, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN INITIAL KNEE ARTHROPLASTY, THE SURGEON FOUND THAT THERE WAS A GAP AT THE LATERAL SIDE BETWEEN THE ARTICULAR SURFACE AND STEM TIBIA JUST AFTER THE ARTICULAR SURFACE INSERTION. SUBSEQUENTLY, THE SURGEON LIGHTLY TAPPED THE ARTICULAR SURFACE FROM THE UPWARD SIDE TO ELIMINATE THE GAP AND THE PROCEDURE WAS COMPLETED. THE SURGEON CONFIRMED THAT THERE WAS NO THIRD BODY OR SOFT TISSUE BETWEEN THE IMPLANTS UPON THE SURFACE INSERTION. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13334445 ↗
• InjuryDec 22, 2021Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY ONE MONTH POST IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13062005 ↗
• InjuryNov 4, 2021Adverse 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: Muscular Rigidity

  MAUDE report 12751236 ↗
• InjuryMar 18, 2020Unstable; Unstable

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY ONE YEAR AND FIVE MONTHS POST IMPLANTATION DUE TO INSTABILITY. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Information

  MAUDE report 9847868 ↗

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