PERSONA® Vivacit-E® 42-5122-005-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024236561), received between May 19, 2022 and May 19, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Noise, Audible” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K121771, K172524); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2022Adverse Event Without Identified Device or Use Problem; Noise, Audible; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Noise, Audible; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY WITHOUT COMPLICATIONS. SUBSEQUENTLY, THE PATIENT HAS REPORTED ONGOING PAIN, SWELLING, AND POPPING IN THE KNEE FOR THE PAST TWO YEARS AND FOUR MONTHS SINCE IMPLANTATION. ADDITIONALLY, THE PATIENT IS HAVING RANGE OF MOTION ISSUES WITH ONE KNEE AND CANNOT BEND OR KNEEL. THE PATIENT HAS HAD BILATERAL KNEE REPLACEMENTS AND IT IS UNKNOWN WHICH KNEE IS HAVING RANGE OF MOTION COMPLICATIONS. NO MEDICAL INTERVENTION HAS BEEN REPORTED AT THE TIME OF THIS REPORT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 14437376 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121771, K172524. 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