PERSONA® Vivacit-E® 42-5122-004-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024236448), received between Apr 22, 2021 and May 23, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 23, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Aseptic loosening; Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 22080509 ↗
• MalfunctionApr 22, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT AFTER THE SURGEON INSERTED ARTICULAR SURFACE IMPLANT, THEY NOTICED THERE WAS A GAP AT THE ANTERIOR PART BETWEEN THE ARTICULAR SURFACE AND THE TIBIA TRAY. THE SURGEON WAS NOT SATISFIED WITH THE PLACEMENT OF THE INSERT AND HE INSISTED TO REINSERT THE SAME ARTICULAR SURFACE. UNFORTUNATELY, THE ARTICULAR SURFACE STILL COULD NOT SIT PROPERLY INTO THE TIBIAL TRAY. THEREFORE, THE SURGEON REQUESTED TO OPEN THE NEW ARTICULAR SURFACE. WITH THE NEW ARTICULAR SURFACE IT CAN SIT PROPERLY ONTO THE TIBIAL TRAY. THERE WAS NO IMPACT TO THE PATIENT. THERE WAS NO SURGICAL DELAY AND THE SURGICAL TECHNIQUE WAS UTILIZED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11709014 ↗

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