PERSONA® Vivacit-E® 42-5124-008-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024237322), received between Apr 22, 2025 and Aug 24, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2026Difficult to Insert

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50411087 ↗
• InjuryDec 8, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

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

  Patient problems: Joint Laxity; Pain

  MAUDE report 23747563 ↗
• MalfunctionSep 6, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE SURGEON COULD NOT LOCK DOWN THE ARTICULAR SURFACE DESPITE IT BEING IN THE RIGHT POSITION. SURGEON TRIED A FEW TIMES BUT STILL COULDN¿T HEAR THE LOCK, VISIBLY NOT LOCKED IN AS WELL. THEY REQUESTED TO OPEN A NEW ONE AND MANAGE TO LOCK IT IN. ATTEMPTS HAVE BEEN MADE, AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22988387 ↗
• InjuryApr 22, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT DEVELOPED PAIN, SWELLING, AND THERE WAS CONCERN FOR PROSTHESIS FAILURE ON RADIOGRAPH. THE PATIENT WAS REVISED WITH PLACEMENT OF COMPETITOR PRODUCT APPROXIMATELY 5 YEARS AND 3 MONTHS POST IMPLANTATION. THE INITIAL PATELLA WAS RETAINED. INTRA-OPERATIVE FINDINGS INCLUDED SCAR TISSUE, SIGNIFICANT POLY WEAR, AND METALLOSIS. NO FURTHER DETAILS HAVE BEEN PROVIDED AT THIS TIME.

  Patient problems: Failure of Implant; Metal Related Pathology; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 21882284 ↗

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