PERSONA® Vivacit-E® 42-5226-007-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024244603), received between Jul 20, 2021 and May 6, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Positioning Failure” (1 report).

10 other recalls cover devices cleared under the same FDA submission (K123459); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Positioning Failure

  IT WAS REPORTED THAT DURING AN INITIAL TKA, AN ARTICULAR SURFACE COULD NOT BE FIXED TO THE TIBIAL PLATE, AND ANOTHER ARTICULAR SURFACE HAD TO BE OPENED. AS A RESULT, THERE WAS A DELAY OF 45MIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25094425 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REVISION FOR UNKNOWN REASONS. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 23366722 ↗
• InjuryNov 10, 2023Adverse 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 18111051 ↗
• InjuryJun 1, 2022Adverse 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 TO ADDRESS DEEP, (B)(6) INFECTION APPROXIMATELY ONE (1) MONTH POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bacterial Infection

  MAUDE report 14564329 ↗
• InjuryJul 20, 2021Unstable; Unstable

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

  Patient problems: Pain

  MAUDE report 12198252 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123459. One submission often covers many models, so check the product and lot details in each record.

• Z-1052-2015 · Dec 11, 2014 · Terminated
  Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04. Product Usage: The Persona TASPs are sterilizab
• Z-2578-2014 · Aug 7, 2014 · Terminated
  PERSONA The Personalized Knee System Tibial Articular Surface Provisional Left with the following: Size CD +0 mm Thickness Bottom(TB); Size CD +6 mm Thickness Bottom; Size EF +0 m
• Z-2580-2014 · Aug 7, 2014 · Terminated
  PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional Left Size 3-7 CD Top; Left Size 4-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12 J Top; Right Size 3
• Z-2577-2014 · Aug 7, 2014 · Terminated
  PERSONA The Personalized Knee System CR Tibial Articular Surface Provisional with the following: Left Size 3-9 CD Top; Left Size 3-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12
• Z-2575-2014 · Aug 7, 2014 · Terminated
  PERSONA The Personalized Knee System Constrained Tibial Articular Surface Provisional BOTTOM with the following: L CD +0MM; L CD +6MM; L EF +0MM;L EF +6MM; L GH +0MM; L GH +6MM;
• Z-2579-2014 · Aug 7, 2014 · Terminated
  PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional Left with Size 3-5 CD Top; Size 6-9 CD Top; Size 3-5 EF Top; Size 6-9 EF Top; Size 10-11 EF Top; Size 6
• Z-2576-2014 · Aug 7, 2014 · Terminated
  PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial Articular Surface Provisional TOP with the following: L 3-5 CD; L 6-9 CD; L 3-5 EF; L 6-9 EF; L 10-11 E
• Z-2300-2014 · Jun 10, 2013 · Terminated
  Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile PSN A/S PROV L CD BOTTOM +0MM PSN A/S PROV L CD BOTTOM +6MM PSN A/S PROV L EF BOTT
• Z-2301-2014 · Jun 10, 2013 · Terminated
  Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Provisional Top Nonsterile TASP MLC L 3-5 CD TOP TASP MLC L 6-9 CD TOP TASP MLC L 3-5 EF TOP TASP MLC L 6-9
• Z-2298-2014 · Jun 10, 2013 · Terminated
  Persona (TM) The Personalized Knee System CR Tibial Articular Surface Provisional Top Nonsterile TASP CR L 3-9 CD TOP