PERSONA® Vivacit-E® 42-5122-006-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024236615), received between Jan 11, 2021 and Mar 20, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT COMPLETED MULTIPLE PT SESSIONS WITHOUT IMPROVEMENT IN ROM AND COMPLAINED OF STIFFNESS AND DIFFICULTY AMBULATING. OPEN ARTHROLYSIS WITH REVISION OF THE FEMORAL COMPONENT AND REPLACEMENT OF THE ARTICULAR SURFACE OCCURRED NINE MONTHS POST IMPLANTATION WITHOUT ANY KNOWN COMPLICATIONS. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Loss of Range of Motion

  MAUDE report 18940151 ↗
• InjuryMar 12, 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: Adhesion(s); Joint Impingement; Joint effusion; Loss of Range of Motion; Osteolysis; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 18890616 ↗
• MalfunctionJan 11, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE TIBIAL INSERT WOULD NOT SEAT INTO THE TIBIAL TRAY DURING A LEFT TOTAL KNEE ARTHROPLASTY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11152753 ↗

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