PERSONA® Vivacit-E® 42-5224-009-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024243910), received between Oct 7, 2021 and Mar 13, 2025 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DEVICE WAS NOT MATING WITH THE IMPLANT. 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 21596834 ↗
• MalfunctionJul 10, 2024Difficult 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 19712495 ↗
• InjuryApr 1, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT EXHIBITED INSTABILITY IN FLEX AND EXTENSION. THE PATIENT THEN UNDERWENT REVISION SURGERY TO EXCHANGE THE ARTICULAR SURFACE AND IMPLANT A THICKER BEARING. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 19016134 ↗
• InjurySep 26, 2022Fracture; Unstable; Fracture; Unstable

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT KNEE SURGERY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO INSTABILITY APPROXIMATELY 7 YEARS LATER. THE ARTICULAR SURFACE WAS REVISED. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Hyperextension; Joint Laxity; Joint effusion; Synovitis

  MAUDE report 15486936 ↗
• InjuryJul 20, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS A HEMATOMA APPROXIMATELY THREE (3) MONTHS POST-OPERATIVELY. UPON REMOVAL, COUNTLESS VERTICAL LINES WERE FOUND ON THE SURFACE OF THE ARTICULAR SURFACE. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Hematoma

  MAUDE report 15064292 ↗
• InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT CLAIMS TO SUFFER FROM PAIN, ESPECIALLY AT NIGHT, JUST ABOVE THE KNEE ON THE RIGHT SIDE. THE PATIENT STATES IT FEELS LIKE SOMEONE IS STABBING HIM WITH A SHARP KNIFE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 14272870 ↗
• InjuryOct 7, 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

  MAUDE report 12589483 ↗

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