PERSONA® Vivacit-E® 42-5124-007-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024237278), received between Jul 27, 2022 and Jul 19, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, OVER TWO (2) YEARS POST-IMPLANTATION, THE PATIENT IS EXPERIENCING PAIN, SWELLING, STIFFNESS, AND TROUBLE WALKING WITH THE LEFT KNEE. NO ADDITIONAL MEDICAL INTERVENTION HAS BEEN REPORTED. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema

  MAUDE report 17350630 ↗
• MalfunctionJul 27, 2022Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

  IT WAS REPORTED THAT AN ARTICULAR SURFACE WOULD NOT SEAT IN THE TIBIAL TRAY. AFTER CEMENTING, THE SURGEON CONFIRMED THERE WERE NO SUBSTANCES SUCH AS SOFT TISSUE AND THAT CEMENT PARTICLES DIDN'T REMAIN BETWEEN ARTICULAR SURFACE AND TIBIA PLATE. AFTER THAT HE INSERTED THE ARTICULAR SURFACE INTO TIBIA PLATE IN ACCORDANCE WITH THE SURGICAL TECHNIQUE, HE FOUND THAT THERE WAS 1MM OR 2MM GAP ON ANTERIOR BETWEEN THESE IMPLANTS. HE REMOVED THE SURFACE AND RE-INSERTED IT TO THE TIBIA PLATE. HOWEVER, THE SAME PROBLEM OCCURRED AGAIN. SUBSEQUENTLY, 1MM THINNER ARTICULAR SURFACE WAS USED TO COMPLETE THE PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE. HOWEVER; NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15111777 ↗

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