Persona® Natural Tibia® Trabecular Metal® 42-5300-075-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024510586), received between Mar 26, 2020 and Feb 26, 2025 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K121771, K173417); 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 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: Failure of Implant

  MAUDE report 21469432 ↗
• MalfunctionFeb 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POST-OPERATIVE FRACTURE OF THE TIBIAL TRAY APPROXIMATELY ONE (1) YEAR FOLLOWING RIGHT KNEE ARTHROPLASTY. THE PATIENT IS DOING WELL AND THERE IS NO PLAN FOR REVISION AT THIS TIME. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21401608 ↗
• InjuryAug 14, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT WAS REVISED ONE YEAR AND SEVEN MONTHS POST IMPLANTATION DUE TO TIBIAL LOOSENING AND SUBSIDENCE. THE ARTICULAR SURFACE WAS ALSO REVISED AND THE PATELLA WAS RESURFACED AT THAT TIME AS A BEST PRACTICE. NO FURTHER PATIENT DETAILS ARE AVAILABLE DUE TO PRIVACY LAWS.

  Patient problems: Failure of Implant

  MAUDE report 19980887 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, ONE YEAR POST-OP, THE PATIENT WAS REVISED DUE TO REDUCED FLEXION AND EXTENSION RANGE OF MOTION. ONLY THE TIBIA WAS REVISED. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion

  MAUDE report 19927688 ↗
• InjuryMar 6, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY TWO AND A HALF YEARS POST IMPLANTATION DUE TO LOOSENING OF THE TIBIAL TRAY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18845987 ↗
• InjuryDec 27, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS ASEPTIC LOOSENING POST-OPERATIVELY. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 18400495 ↗
• InjuryNov 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Bone Fracture(s)

  MAUDE report 12820493 ↗
• InjuryOct 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A RIGHT TKA WAS PERFORMED, BUT HAD TO BE REVISED DUE TO LCL FAILURE. IMPLANTS WERE REMOVED AND A RHK WAS IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Damage to Ligament(s)

  MAUDE report 12561551 ↗
• InjuryMar 26, 2020Migration; Migration

  IT WAS REPORTED THAT APPROXIMATELY 7 MONTHS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO SUBSIDENCE OF THE TIBIAL COMPONENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Information

  MAUDE report 9886243 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121771, K173417. 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