PERSONA® Vivacit-E® 42-5124-004-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024237001), received between Aug 26, 2022 and Aug 12, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S ARTICULAR SURFACE DISLODGED ANTERIORLY APPROXIMATELY ONE (1) MONTH FOLLOWING KNEE ARTHROPLASTY. THE PATIENT IS NOT EXHIBITING ANY SYMPTOMS AND DOES NOT WISH TO PROCEED WITH A REVISION AT THIS TIME. THE SURGEON IS MONITORING THE PATIENT'S CONDITION. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 22782660 ↗
• InjuryJun 12, 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 MANIPULATION UNDER ANESTHESIA TO ADDRESS STIFFNESS AND DECREASED RANGE OF MOTION NINE (9) WEEKS FOLLOWING A LEFT KNEE ARTHROPLASTY. INITIAL OPERATIVE NOTES NOTED THE PATIENT HAD ADVANCED BONE-ON-BONE OSTEOARTHRITIS. NO COMPLICATIONS WERE NOTED DURING THE PROCEDURE. MANIPULATION OPERATIVE NOTES NOTED THAT WHEN THE MANIPULATION WAS PERFORMED, THE SURGEON FELT THE INTRAARTICULAR ADHESION SLOWLY RELEASE AND THE KNEE STEADILY INCREASE IN FLEXION. PRIOR TO THE PROCEDURE, THE PATIENT'S RANGE OF MOTION IN PASSIVE FLEXION WAS 103-104 DEGREES AND AFTER THE PROCEDURE IT WAS 141 DEGREES. STIFFNESS WAS RESOLVED WITHIN TWO (2) WEEKS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

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

  MAUDE report 17105704 ↗
• MalfunctionAug 26, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING KNEE ARTHROPLASTY WHILE THE SURGEON WAS INSERTING THE ARTICULAR SURFACE, IT WOULD NOT CLICK INTO THE TIBIAL TRAY. ANOTHER ARTICULAR SURFACE WAS USED 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 15303155 ↗

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