Persona® Natural Tibia® Trabecular Metal® 42-5300-075-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00889024510579), received between Mar 10, 2021 and Nov 20, 2025 — classified as 15 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (9 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2025Adverse 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: Pain; Periprosthetic fracture

  MAUDE report 23604829 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A KNEE REVISION PROCEDURE ABOUT TWO YEARS, ONE MONTH POST IMPLANTATION FOR PAIN AND INSTABILITY. THE TIBIA WAS REVISED FOR CAUSE AND THE BEARING WAS ALSO REPLACED BY PROCEDURE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22495978 ↗
• InjuryFeb 25, 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 21460084 ↗
• InjuryJan 16, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, EIGHT (8) MONTHS POST-IMPLANTATION, THE PATIENT EXPERIENCED SUDDEN PAIN AND UNDERWENT REVISION SURGERY DUE TO SUBSIDENCE OF THE TIBIAL TRAY. THE AFFECTED COMPONENTS WERE REPLACED AND THE FEMORAL COMPONENTS REMAIN INTACT. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 21172616 ↗
• InjuryAug 20, 2024Fracture; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Aseptic loosening; Insufficient Information; Osteolysis

  MAUDE report 20003077 ↗
• InjuryJun 5, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. APPROXIMATELY 5 MONTHS POST-OP, THE PATIENT WAS REVISED DUE TO LOOSENING AND PAIN. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 19469353 ↗
• InjuryJan 11, 2024Loosening 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: Cyst(s); Failure of Implant

  MAUDE report 18490889 ↗
• InjuryJun 21, 2023Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE SIX MONTHS POST IMPLANTATION DUE TO TIBIAL LOOSENING AND FRACTURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 17171252 ↗
• InjuryJun 15, 2023Adverse 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); Unequal Limb Length

  MAUDE report 17139666 ↗
• MalfunctionJan 25, 2023Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

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

  Patient problems: Failure of Implant

  MAUDE report 16240539 ↗
• InjuryOct 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT DEVELOPED POST-OPERATIVE FRACTURE OF THE TIBIAL TRAY APPROXIMATELY THREE (3) YEARS FOLLOWING KNEE ARTHROPLASTY WITHOUT TRAUMA. AT THIS TIME, THE PATIENT IS NOT EXPERIENCING PAIN OR INSTABILITY, HOWEVER, IS SCHEDULED TO BE REVISED WITHIN THE NEXT TWO (2) MONTHS. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 15672274 ↗
• InjurySep 1, 2022Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL BILATERAL KNEE SURGERY. APPROXIMATELY 5 MONTHS LATER, THE PATIENT UNDERWENT A BILATERAL KNEE REVISION. THE PATIENT'S LEFT TIBIAL COMPONENT WAS REVISED DUE TO SUSPECTED SUBSIDENCE AND POSSIBLE ASEPTIC LOOSENING. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 15334027 ↗
• MalfunctionJul 20, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT WHEN THE CIRCULATOR WAS OPENING THE OUTER SEALED PACKAGE SHE STATED IT CAME OFF WAY TOO EASILY. IT WAS DETERMINED THAT IN ORDER TO BE SAFE SHE WOULD NOT PASS IT TO THE SURGICAL FIELD. SHE PROCEEDED TO OPEN AND PASS THE INNER SEALED PACKAGE. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15064195 ↗
• InjuryMar 15, 2022Migration; Migration

  IT WAS REPORTED THAT AFTER FOLLOW UP ON A TOTAL KNEE ARTHROPLASTY, IT WAS DISCOVERED THE PATIENT HAD A TIBIA BONE FRACTURE AND THE TIBIAL PLATE WAS SUBSIDING. THE PATIENT WAS REVISED APPROXIMATELY TWO MONTHS POST IMPLANTATION; THE FEMUR, ARTICULAR SURFACE, AND TIBIA WERE REPLACED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 13771422 ↗
• InjuryNov 19, 2021Loosening 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 12843283 ↗
• InjuryOct 1, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT PATIENT UNDERWENT LEFT KNEE REVISION APPROXIMATELY THREE YEARS POST IMPLANTATION DUE TO REPORTED PAIN IN TIBIA AND SUSPECTED LOOSENING OF THE TIBIA. TIBIAL COMPONENT AND ARTICULAR SURFACE WERE EXCHANGED WITHOUT COMPLICATION. ATTEMPTS WERE MADE AND NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 12561206 ↗
• InjuryMar 10, 2021Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY FOUR MONTHS POST-IMPLANTATION DUE TO TIBIAL LOOSENING. NO BONE IN GROWTH WAS SEEN ON THE EXPLANTED TIBIA COMPONENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11453405 ↗

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