PERSONA™ Natural Tibia™ Trabecular Metal™ 42-5300-079-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024246553), received between Mar 2, 2020 and Sep 25, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (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.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent an initial knee surgery. Subsequently, the patient is scheduled to be revised approximately 3 years post-op due to instability from an excessive tibial slope. Attempts have been made and all available information has been provided.

  Patient problems: Joint Laxity

  MAUDE report 50896801 ↗
• InjuryMar 26, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY 9.5 MONTHS POST-IMPLANTATION DUE TO A TIBIAL COMPONENT FRACTURE. FOLLOWING THE ONSET OF PAIN, EVALUATION REVEALED A FRACTURE OF THE TIBIAL IMPLANT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 24701292 ↗
• InjuryMar 2, 2020Migration; Migration

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

  Patient problems: No Information

  MAUDE report 9774208 ↗

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