PERSONA® Vivacit-E® 42-5220-004-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00889024241558), received between Feb 28, 2020 and Feb 17, 2026 — classified as 16 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Unstable” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K121771, K172524); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Laxity

  MAUDE report 24363908 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY COMPLETED. APPROXIMATELY 3 MONTHS POST-OP, THE PATIENT EXPERIENCED STIFFNESS AND LIMITED RANGE OF MOTION. SUBSEQUENTLY, THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA AND THE PATIENT'S SYMPTOMS HAVE REPORTEDLY IMPROVED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Arthrofibrosis; Loss of Range of Motion

  MAUDE report 22936910 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION TO ADDRESS HYPEREXTENDING INSTABILITY APPROXIMATELY EIGHTEEN (18) MONTHS POST-OPERATIVELY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 22897483 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT KNEE REVISION SURGERY FOR UNKNOWN REASONS ABOUT 5 YEARS, 5 MONTHS POST IMPLANTATION.

  Patient problems: Insufficient Information

  MAUDE report 22679885 ↗
• InjuryJul 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: Erythema; Hemarthrosis; Pain; Swelling/ Edema

  MAUDE report 22438793 ↗
• InjuryDec 12, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

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

  Patient problems: Extraskeletal ossification; Failure of Implant; Joint Laxity; Joint effusion; Muscle/Tendon Damage; Osteopenia/ Osteoporosis; Swelling/ Edema

  MAUDE report 20912021 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY FIFTEEN (15) MONTHS POST-IMPLANTATION DUE TO OSTEOLYSIS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Osteolysis

  MAUDE report 19351554 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY THREE YEARS POST-IMPLANTATION DUE TO PAIN AND INSTABILITY. THE TIBIAL INSERT WAS REMOVED AND REPLACED.

  Patient problems: Pain

  MAUDE report 19143708 ↗
• MalfunctionNov 2, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE ARTICULAR SURFACE WAS NOT MATING WITH THE TIBIAL COMPONENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15714047 ↗
• InjurySep 6, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 11 MONTHS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO PAIN, INSTABILITY, AND TIBIAL SUBSIDENCE. ALL COMPONENTS WERE EXCHANGED.

  Patient problems: Joint Laxity; Pain

  MAUDE report 15361585 ↗
• InjuryJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Embolism/Embolus

  MAUDE report 13203016 ↗
• InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT REPORTED SEVERE PAIN AND DIFFICULTIES WITH LIMITED RANGE OF MOTION AND THE PATIENT UNDERWENT AN UNCOMPLICATED MANIPULATION UNDER ANESTHESIA APPROXIMATELY 6 WEEKS LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 13175900 ↗
• MalfunctionDec 3, 2021Packaging Problem; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12924449 ↗
• InjuryOct 1, 2021Adverse 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 12561543 ↗
• InjurySep 22, 2021Unstable; Unstable

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

  Patient problems: Hyperextension; Joint Laxity

  MAUDE report 12512703 ↗
• InjurySep 8, 2021Unstable; Unstable

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

  Patient problems: Failure of Implant

  MAUDE report 12437961 ↗
• InjuryJan 28, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT HAD A TOTAL KNEE ARTHROPLASTY AND 11 MONTHS AFTER THE PROCEDURE THE PATIENT WAS REVISED DUE TO LOOSENING AND LIMITED RANGE OF MOTION. DURING THE PROCEDURE AFTER THE SURFACE TRIAL WAS INSERTED, THE PATIENT¿S PATELLA LIGAMENT WAS DAMAGED AND STAPLES WERE USED TO FIX THE LIGAMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Damage to Ligament(s); Loss of Range of Motion

  MAUDE report 11244457 ↗
• InjuryFeb 28, 2020Adverse 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: Limited Mobility Of The Implanted Joint; Muscular Rigidity; Pain; Patient Problem/Medical Problem

  MAUDE report 9768966 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121771, K172524. One submission often covers many models, so check the product and lot details in each record.

• Z-1917-2016 · May 11, 2016 · Terminated
  Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.
• Z-1266-2015 · Jan 28, 2015 · Terminated
  Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer For use in eit