PERSONA® Vivacit-E® 42-5124-007-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024237254), received between Jan 5, 2022 and Nov 18, 2025 — classified as 2 injuries, 3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED DURING KNEE ARTHROPLASTY THAT THE SURGEON WAS UNABLE TO SEAT THE ARTICULAR SURFACE IMPLANT ON THE TIBIAL TRAY. ALL SOFT TISSUE WAS CLEARED AND MULTIPLE WERE MADE, HOWEVER, THE DEVICE COULD NOT BE SEATED AND A NEW ARTICULAR SURFACE IMPLANT WAS OPENED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582448 ↗
• InjuryNov 22, 2023Adverse 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: Joint Laxity; Pain

  MAUDE report 18190863 ↗
• MalfunctionMar 10, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN INITIAL TOTAL KNEE ARTHROPLASTY, THE ARTICULAR SURFACE IMPLANT WOULD NOT NEATLY SEAT ONTO THE TIBIAL TRAY. SUBSEQUENTLY, A NEW ARTICULAR SURFACE WAS UTILIZED AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATION OR IMPACT TO THE PATIENT. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13720390 ↗
• InjuryJan 20, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED VIA A CLINICAL STUDY THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY TWO MONTHS POST IMPLANTATION, THE PATIENT PRESENTED WITH SYMPTOMS INCLUDING PAIN, STIFFNESS, AND LIMITED RANGE OF MOTION. THE PATIENT THEN UNDERWENT A MANIPULATION UNDER ANESTHESIA WITHOUT COMPLICATION. AT THE INITIAL POST OPERATIVE VISIT, THE PATIENT EXHIBITED INCREASED RANGE OF MOTION AND SLOW RELEASE OF ADHESIONS.

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

  MAUDE report 13307615 ↗
• MalfunctionJan 5, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING IMPLANTATION, A LOOSE SLIVER OF AN OBJECT WAS RETRIEVED. THE SURGEON REMARKED THAT THIS WAS ADHERED TO THE ARTICULAR SURFACE, AND HAD TO BE REMOVED FROM THE SURGICAL SITE WITH THE USE OF AN ARTERY FORCEPS. IT WAS REMARKED BY THE SURGICAL TEAM THAT THIS COULD HAVE BEEN PART OF THE ARTICULAR SURFACE (AS A MANUFACTURING DEFECT), AND MAY NOT HAVE BEEN PART OF THE CEMENT USED. THE CEMENT USED DURING THE SURGERY WAS EITHER PALACOS MV OR SMARTSET GHV. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13169997 ↗

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