PERSONA® Vivacit-E® 42-5124-007-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024237261), received between Oct 23, 2020 and Mar 12, 2025 — classified as 3 injuries, 2 malfunctions.

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); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2025Difficult to Insert; Difficult to Insert

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21587233 ↗
• MalfunctionFeb 4, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING AN INITIAL TOTAL KNEE ARTHROPLASTY, THE ARTICULAR SURFACE WOULD NOT FIT PROPERLY WITH THE TIBIAL TRAY. THE OPERATION WAS COMPLETED WITH A SMALLER ARTICULAR SURFACE WITHOUT COMPLICATION. THERE WAS NO PATIENT IMPACT OR ADVERSE EVENTS AS A RESULT OF THE MALFUNCTION. ALL AVAILABLE INFORMATION HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21303331 ↗
• InjuryOct 10, 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: Ambulation or Postural Difficulties; Crepitus; Loss of Range of Motion; Pain

  MAUDE report 20419511 ↗
• InjuryDec 13, 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 ARTHROPLASTY REVISION TO ADDRESS FLEXION/EXTENSION INSTABILITY APPROXIMATELY FOUR (4) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 18322746 ↗
• InjuryOct 23, 2020Noise, Audible; Noise, Audible

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

  Patient problems: Ambulation or Postural Difficulties; Nerve Damage; Pain; Swelling; Synovitis

  MAUDE report 10726888 ↗

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