PERSONA® Vivacit-E® 42-5126-007-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024238077), received between Dec 20, 2023 and Dec 8, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryDec 8, 2025Adverse 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 23744298 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Joint Laxity; Periprosthetic fracture

  MAUDE report 22902065 ↗
• InjuryAug 6, 2025Adverse 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: Joint Laxity

  MAUDE report 22725016 ↗
• InjuryFeb 25, 2025Adverse 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 SYNOVECTOMY TO ADDRESS FIBROSIS APPROXIMATELY FOUR (4) YEARS FOLLOWING LEFT KNEE ARTHROPLASTY. THE PATIENT FURTHER UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION OF THE ARTICULAR SURFACE TO ADDRESS ARTHROFIBROSIS ACCOMPANIED BY CONTINUED PAIN, INSTABILITY AND LIMITED RANGE OF MOTION APPROXIMATELY SIX (6) YEARS POST-OPERATIVELY. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. REVISION OPERATIVE NOTES NOTED SIGNIFICANT SCARRING/ARTHROFIBROSIS WITHIN THE JOINT. FEMORAL UNDERMINING WAS ADDITIONALLY NOTED MEDIALLY AND LATERALLY, HOWEVER, NO FEMORAL COMPONENT LOOSENING WAS FOUND. THE PATIENT'S QUADRICEPS MECHANISM WAS NOTED TO BE SCARRED, CONTRIBUTING TO THE LIMITED FLEXION. THE SURGEON DECREASED THE ARTICULAR SURFACE SIZE TO INCREASE FLEXION OF THE KNEE. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Fibrosis; Loss of Range of Motion; Muscle/Tendon Damage; Osteolysis; Pain

  MAUDE report 21457418 ↗
• InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD NERVE ABLATIONS PERFORMED DUE TO CHRONIC PROBLEMS POST IMPLANTATION. THE PATIENT IS PLANNING A LEFT KNEE REVISION SURGERY, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 19369950 ↗
• InjuryDec 20, 2023Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  UPON RECEIPT OF ADDITIONAL INFORMATION, THIS DEVICE WAS DETERMINED TO BE NOT REPORTABLE. THE PREVIOUSLY REPORTED DISLOCATION WAS REFERRING TO THE FRACTURED BONE FRAGMENTS AND NOT THE ARTICULAR SURFACE. AS THE PERIPROSTHETIC FRACTURE WAS OF THE MEDIAL FEMORAL CONDYLE, ONLY THE IMPLANTED FEMORAL COMPONENT HAS BEEN IMPLICATED IN THE REPORTED EVENT. THE INITIAL REPORT FOR THIS DEVICE WAS FORWARDED IN ERROR.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Osteopenia/ Osteoporosis; Pain; Swelling/ Edema

  MAUDE report 18366884 ↗

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