PERSONA® Vivacit-E® 42-5126-010-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024238275), received between Feb 18, 2022 and Jan 12, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Deformation” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT KNEE SURGERY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS APPROXIMATELY 2 MONTHS POST-OP. ONLY THE POLY WAS REVISED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24035146 ↗
• InjuryJan 27, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PATIENT WITH RHEUMATOID ARTHRITIS UNDERWENT AN INITIAL KNEE SURGERY WITH PERSONA IMPLANTS USING THE ROSA ROBOTIC SYSTEM. APPROXIMATELY TWO MONTHS POST IMPLANTATION, THE PATIENT CONTINUED TO FORM JOINT FLUID AND BLOODYING. IT WAS THEN DECIDED TO PERFORM A DAIR PROCEDURE, DURING WHICH EXTENSIVE PITTING WAS DETECTED ON THE SURFACE OF THE POLYETHYLENE. THE IMPLANT WAS REMOVED AND REPLACED WITH A CPS OF THE SAME SIZE AND THICKNESS. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 21241440 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD A KNEE REPLACEMENT SURGERY. SUBSEQUENTLY, 2 YEARS POST PROCEDURE THE PATIENT IS STILL SUFFERING FROM PAIN WHILE PERFORMING DAILY ACTIVITIES. PATIENT CLAIMS HE HAS BEEN FACING PAIN SINCE DAY OF THE SURGERY AND CURRENTLY CAN FEEL THE PAIN NEAR THE BONE OVERHANG AREA. POSSIBLE FUTURE REVISION.

  Patient problems: Pain

  MAUDE report 16886086 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED VIA A CLINICAL STUDY THAT A PATIENT UNDERWENT A REVISION PROCEDURE TWO YEARS POST IMPLANTATION DUE TO INSTABILITY. SUBSEQUENTLY, AT EIGHT MONTHS POST OP, THE PATIENT EXPERIENCED A SEVERE EFFUSION. ONE YEAR AND FIVE MONTHS LATER, THE PATIENT REPORTED SEVERE STIFFNESS AND PAIN. THE FINAL OUTCOME HAS BEEN REPORTED AS TOLERATED WITH NO MEDICAL INTERVENTION. THE PRODUCTS REMAIN IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Bacterial Infection; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 13559939 ↗

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-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-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-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-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