PERSONA® Vivacit-E® 42-5226-007-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024244610), received between Oct 21, 2019 and Mar 28, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 28, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY ONE YEAR POST-IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE A CLUNK NOISE FROM THE IMPLANTED PROSTHESIS AND SUBSEQUENTLY UNDERWENT REVISION SURGERY OF THE ARTICULAR SURFACE. THE BEARING WAS EXCHANGED FOR A LARGER SIZE WITHOUT COMPLICATION. IT WAS REPORTED THAT ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 21720480 ↗
• InjuryOct 21, 2019Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY THREE WEEKS POST IMPLANTATION DUE TO FRACTURE OF THE PERSONA FEMUR. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: Bone Fracture(s); No Information

  MAUDE report 9215644 ↗

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-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-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-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-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-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-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-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
• 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-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