PERSONA® Vivacit-E® 42-5124-007-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024237285), received between Oct 23, 2019 and Dec 9, 2022 — 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.

• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY PATIENT¿S LEGAL COUNSEL THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY. LEGAL COUNSEL IS REPORTING PATIENT HAS FILED AN UNKNOWN ALLEGATION. PATIENT HAS NOT BEEN REVISED TO DATE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15950468 ↗
• InjuryJan 24, 2022Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY 8 MONTHS POST IMPLANTATION DUE TO SWELLING, PAIN, INSTABILITY, SCAR TISSUE, SUBLUXATION AND QUAD TENDON REPAIR. THE LEFT QUAD TENDON WAS REPAIRED WITH EXCHANGE OF THE ARTICULATING SURFACE WITHOUT COMPLICATIONS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Muscle/Tendon Damage; Pain; Scar Tissue; Subluxation; Swelling/ Edema; Synovitis

  MAUDE report 13336321 ↗
• MalfunctionOct 23, 2019Packaging Problem; Packaging Problem

  NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORTING.

  Patient problems: No Patient Involvement

  MAUDE report 9225252 ↗

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