Persona® Natural Tibia® Trabecular Metal® 42-5300-083-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024510623), received between Apr 12, 2021 and Aug 21, 2025 — classified as 7 injuries.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 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

  MAUDE report 22864001 ↗
• InjuryOct 17, 2024Migration; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY THREE-AND-A-HALF YEARS POST-IMPLANTATION DUE TO INSTABILITY AND POSSIBLE TIBIAL SUBSIDENCE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 20470000 ↗
• InjuryOct 2, 2023Loosening 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 YEARS POST-IMPLANTATION DUE TO TIBIAL TRAY LOOSENING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 17854704 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY WAS PERFORMED. SUBSEQUENTLY, APPROXIMATELY 2 MONTHS POST PROCEDURE, THE PATIENT HAD A PARTIAL WOUND DEHISCENCE, RESULTING IN EXTENSIVE WOUND CARE AND DELAYING FUNCTIONAL RECOVERY. THE PATIENT WAS PLACED ON RANGE OF MOTION RESTRICTIONS TO ALLOW WOUND HEALING. AFTER FULL HEALING OF THE WOUND OCCURRED, PHYSICAL THERAPY AND MANIPULATION OF THE JOINT RESUMED TO RESTORE FULL FUNCTION. THE PATIENT REMAINS SATISFIED WITH NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Loss of Range of Motion; Pain; Wound Dehiscence

  MAUDE report 17169707 ↗
• InjurySep 1, 2022Loosening 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. SUBSEQUENTLY, THE TIBIAL, FEMORAL, AND PATELLAR COMPONENTS WERE REVISED APPROXIMATELY 1 YEAR LATER DUE TO 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 15334038 ↗
• InjuryOct 4, 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: Ambulation or Postural Difficulties; Inadequate Osseointegration; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 12572759 ↗
• InjuryApr 12, 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: Unspecified Infection

  MAUDE report 11647660 ↗

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