PERSONA® Vivacit-E® 42-5126-005-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024237933), received between Dec 8, 2021 and Jan 5, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Use of Device Problem; Improper or Incorrect Procedure or Method

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959939 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED DEEP VEIN THROMBOSIS ACCOMPANIED BY PAIN AND LOWER LEG SWELLING APPROXIMATELY ONE (1) WEEK FOLLOWING LEFT KNEE ARTHROPLASTY. THE PATIENT STAYED OVERNIGHT AT THE HOSPITAL AND TREATED WITH ELIQUIS WHILE INPATIENT AND WAS PRESCRIBED XARELTO WHEN RELEASED. THE PATIENT APPEARED TO BE IMPROVING WHEN SEEN TWO (2) WEEKS LATER. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Cyst(s); Pain; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 21055540 ↗
• InjuryApr 11, 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 ARTHROSCOPY APPROXIMATELY SEVEN (7) MONTHS POST-OPERATIVELY TO ADDRESS PATELLAR CLUNK AND A CATCHING FEELING. DURING THE ARTHROSCOPY, SYNOVITIS AND FIBROUS TISSUE AT THE SUPERIOR POLE OF THE PATELLA WERE IDENTIFIED AND APPEARED TO BE ENGAGING WITH THE BOX OF THE FEMUR AND WAS SCARRED THROUGH THE MEDIAL GUTTER. A SYNOVECTOMY WAS PERFORMED, AND SCAR TISSUE WAS REMOVED WITHOUT COMPLICATION. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Loss of Range of Motion; Pain; Scar Tissue; Synovitis

  MAUDE report 16714486 ↗
• InjuryApr 5, 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 MANIPULATION UNDER ANESTHESIA TO ADDRESS ARTHROFIBROSIS APPROXIMATELY THREE (3) MONTHS FOLLOWING LEFT KNEE ARTHROPLASTY. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 16686625 ↗
• InjuryJun 10, 2022Adverse 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 TO ADDRESS WORSENING PAIN, INCREASING FUNCTIONAL LIMITATIONS AND INSTABILITY APPROXIMATELY ONE YEAR POST-OPERATIVELY. REVISION OPERATIVE NOTES NOTED THE PATELLAR COMPONENT WAS EXAMINED TO BE STABLE AND REMAINED IMPLANTED. REMOVAL OF THE FEMORAL AND TIBIAL COMPONENTS SHOWED MINIMAL BONE LOSS. APPROPRIATE RANGE OF MOTION, STABILITY AND PATELLAR TRACKING WERE ACHIEVED WITH NEW COMPONENTS. NO INTRAOPERATIVE COMPLICATIONS WERE IDENTIFIED AND THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 14653316 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT DEVELOPED A PULMONARY EMBOLISM FOUR DAYS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Embolism/Embolus

  MAUDE report 12960421 ↗

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-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-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-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-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-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