PERSONA® Vivacit-E® 42-5224-008-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024243835), received between Nov 23, 2020 and Dec 12, 2025 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K121771); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 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: Arthrofibrosis; Loss of Range of Motion

  MAUDE report 23790525 ↗
• InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE THREE YEARS POST IMPLANTATION DUE TO INFECTION AND INSTABILITY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Bacterial Infection

  MAUDE report 21277818 ↗
• MalfunctionMar 14, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED WHEN THE STERILE PACKAGE FOR THE POLY WAS OPENED THE SCRUB NOTICED A HAIR ON THE POLY INSIDE THE PLASTIC WRAP. POLY WAS THROUGHLY CLEANED IN BETADINE SOLUTION AND IMPLANTED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18903357 ↗
• InjuryOct 5, 2023Adverse 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. APPROXIMATELY 6 WEEKS POST IMPLANTATION, THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO STIFFNESS AND ARTHROFIBROSIS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Adhesion(s); Loss of Range of Motion; Pain

  MAUDE report 17879585 ↗
• InjuryNov 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BILATERAL TOTAL KNEE REPLACEMENTS. APPROXIMATELY FOUR YEARS AND FOUR MONTHS POST IMPLANTATION, THE PATIENT PRESENTED WITH GENERALIZED PAIN AND SWELLING OF THE RIGHT KNEE. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY OF THE ARTICULAR SURFACE DURING WHICH A SYNOVECTOMY WAS PERFORMED. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 15885843 ↗
• InjuryAug 11, 2021Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAS BEEN EXPERIENCING PAIN, LIMITED ROM, DIFFICULTY AMBULATING, AND SWELLING. HE UNDERWENT AN ARTHROSCOPY PROCEDURE 10 MONTHS POST-PROCEDURE TO REMOVE FLUID & SCAR TISSUE. THE PATIENT CONTINUED TO DO WELL UNTIL HE FELL DUE WHILE WALKING RESULTING IN PATELLAR DISLOCATION WHICH HE REDUCED HIMSELF AND WAS BRACED FOR AN MCL SPRAIN. 25 MONTHS AFTER INITIAL PROCEDURE, HE UNDERWENT A SECOND ARTHROSCOPIC LYSIS OF ADHESIONS WITH MANIPULATION BUT EXPERIENCED DIFFICULTIES WITH THERAPY AND EXERCISES POSTOP DUE TO COVID RECOVERY. THE PATIENT REMAINS DISSATISFIED WITH HIS KNEE DUE TO ONGOING PAIN, SWELLING, AND DECREASED ROM.

  Patient problems: Extraskeletal ossification; Joint Dislocation; Loss of Range of Motion; Osteopenia/ Osteoporosis; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 12307370 ↗
• InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY PERFORMED. SUBSEQUENTLY, APPROXIMATELY 10 MONTHS POST PROCEDURE, THE PATIENT UNDERWENT AN ARTHROSCOPIC LYSIS OF ADHESIONS WITH MANIPULATION DUE TO PAIN AND STIFFNESS. AT FOLLOW UP, THE PATIENT WAS SATISFIED WITH HIS PROGRESS AND COMPLIANT WITH PHYSICAL THERAPY.

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

  MAUDE report 11656885 ↗
• MalfunctionNov 23, 2020Difficult to Insert; Difficult to Insert

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10884553 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121771. 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