PERSONA® Vivacit-E® 42-5226-007-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00889024244580), received between Aug 31, 2022 and Feb 25, 2026 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (3 reports).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, ON AN UNKNOWN TIMEFRAME POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO UNKNOWN COMPLICATIONS. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Crepitus; Insufficient Information; Joint Laxity; Loss of Range of Motion; Pain; Radiolucent Lines; Swelling/ Edema

  MAUDE report 24447140 ↗
• MalfunctionDec 1, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT AN ARTICULAR SURFACE WOULD NOT ASSEMBLE WITH THE TIBIAL TRAY DURING SURGERY. WHEN IMPLANTING THE INSERT, IT DID NOT FIT IN THE TIBIA, AND IT CREATED A POSTERIOR SLOT ON THE UNDERSIDE OF THE POLYETHYLENE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23681716 ↗
• MalfunctionNov 11, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGEON ATTEMPTED TO GET 3 ARTICULAR SURFACES TO SEAT INTO THE IMPLANTED TIBIAL COMPONENT. THE FOURTH ARTICULAR SURFACE ATTEMPTED, WAS SUCCESSFUL. THE SURGEON EXPRESSED THAT THE LOCKING MECHANISM DID NOT SEEM TO WORK ON THE 3 POLYETHYLENES THAT WERE OPENED AND ARE BEING RETURNED. NO PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20651859 ↗
• InjurySep 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; Swelling/ Edema

  MAUDE report 20321354 ↗
• InjuryMay 21, 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; Scar Tissue

  MAUDE report 19360779 ↗
• InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA APPROXIMATELY TWO MONTHS POST IMPLANTATION DUE TO ARTHROFIBROSIS WITH A FLEXION OF SIXTY DEGREES AND STIFFNESS. THE PATIENT CONTINUES TO HAVE MODERATE PAIN AND SWELLING. THE PATIENT HAS PROGRESSED THROUGHOUT THE STUDY, ACHIEVING A RANGE OF MOTION OF ZERO TO ONE HUNDRED TWENTY DEGREES AND COMPLETED THE STUDY WITHOUT FURTHER INTERVENTION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Adhesion(s); Loss of Range of Motion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 18239460 ↗
• MalfunctionJun 13, 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 17117385 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, ABOUT 2 YEARS TWO MONTHS POST PROCEDURE THE PATIENT FELL FOR UNKNOWN REASONS, CAUSING PAIN AND SWELLING. PATIENT WAS SEEN IN THE OFFICE WHERE KNEE WAS ASPIRATED WITHOUT COMPLICATION.

  Patient problems: Fall; Joint effusion; Pain; Swelling/ Edema

  MAUDE report 16914693 ↗
• InjuryMar 24, 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: Ambulation or Postural Difficulties; Joint Laxity; Pain

  MAUDE report 16609438 ↗
• MalfunctionAug 31, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN INITIAL SURGERY, THE SURGEON WAS TRYING TO INSERT THE POLY, HOWEVER, THE IMPLANT WOULD NOT ENGAGE POSTERIORLY WITH THE TIBIAL COMPONENT. DUE TO THIS, THE INSTRUMENT WAS UNABLE TO SNAP THE POLY IN COMPLETELY. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15328443 ↗

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-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-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-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-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-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-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