Persona® Natural Tibia® Trabecular Metal® 42-5300-079-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00889024510609), received between May 28, 2020 and Nov 25, 2024 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS TIBIAL COMPONENT SUBSIDENCE APPROXIMATELY EIGHTEEN (18) MONTHS POST-OPERATIVELY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 20770563 ↗
• InjuryJul 1, 2024Loosening 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 RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY ONE MONTH LATER, THE PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA FOR ARTHROFIBROSIS AND STIFFNESS. THE IMPLANTS REMAINED INTACT. IT WAS NOTED THAT THE PATIENT CONTINUES TO HAVE LIMITED RANGE OF MOTION DUE TO SCAR TISSUE/ADHESIONS. SUBSEQUENTLY, APPROXIMATELY THIRTEEN MONTHS FROM INITIAL IMPLANTATION, A MRI INDICATED TIBIAL SUBSIDENCE AND TIBIAL LOOSENING. NO FURTHER INTERVENTIONS HAVE BEEN REPORTED.

  Patient problems: Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 19645544 ↗
• InjuryJun 25, 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: Failure of Implant; Joint Laxity; Pain

  MAUDE report 19605177 ↗
• InjuryJan 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SURGERY AND WAS REVISED APPROXIMATELY 1.5 YEARS POST-OP DUE TO A FRACTURED TIBIAL COMPONENT. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 18464983 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THE PATIENT PRESENTED WITH PERSISTENT PAIN, SIX MONTHS POST IMPLANTATION. PATIENT IS SCHEDULED TO BE REVISED ON A FUTURE DATE FOR TIBIAL LOOSENING. NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: Osteopenia/ Osteoporosis; Pain

  MAUDE report 18425907 ↗
• InjuryMar 22, 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 REVISION APPROXIMATELY 13 MONTHS POST IMPLANTATION DUE TO PAIN AND LOOSENING. THE TIBIAL COMPONENT AND ARTICULAR SURFACE WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 16590251 ↗
• MalfunctionFeb 27, 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); Pain

  MAUDE report 16443451 ↗
• InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN POST IMPLANTATION. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 15418975 ↗
• 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 RIGHT KNEE SURGERY. APPROXIMATELY 3 MONTHS LATER, THE 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 15334036 ↗
• 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 RIGHT 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 15334030 ↗
• InjuryJul 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A TIBIAL BONE FRACTURE APPROXIMATELY SIX (6) MONTHS FOLLOWING RIGHT KNEE ARTHROPLASTY. A REVISION PROCEDURE IS ANTICIPATED. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 15064285 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. IT WAS REPORTED THAT THE PATIENT DEVELOPED A DEEP VEIN THROMBOSIS APPROXIMATELY 3 DAYS POST IMPLANTATION. THE PATIENT WAS TREATED MEDICALLY AND ISSUE RESOLVED, WITH COMPONENTS REMAINING IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13595337 ↗
• InjurySep 23, 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: Pain; Swelling/ Edema

  MAUDE report 12520087 ↗
• InjuryJun 29, 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: Adhesion(s); Inadequate Osseointegration; Pain

  MAUDE report 12086224 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 10 DAYS POST IMPLANTATION, THE PATIENT WAS DIAGNOSED WITH A DEEP VEIN THROMBOSIS. THE PATIENT WAS PLACED ON ELIQUIS FOR TREATMENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11739471 ↗
• InjuryMay 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT UNILATERAL TOTAL KNEE ARTHROPLASTY ON AND SUBSEQUENTLY, THE PATIENT DEVELOPED A RIGHT LOWER EXTREMITY DVT APPROXIMATELY ONE WEEK LATER, REQUIRING AN UNKNOWN MEDICAL INTERVENTION. THE DVT WAS RESOLVED APPROXIMATELY ONE MONTH LATER.

  Patient problems: Embolism

  MAUDE report 10098492 ↗

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