Persona® Natural Tibia® Trabecular Metal® 42-5300-071-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00889024510562), received between Jun 22, 2020 and Sep 23, 2026 — classified as 22 injuries.

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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Malposition of Device

  It was further reported that the patient underwent an initial right knee surgery. After surgery, the surgeon and staff noticed tibial overhang and oversizing of the tibial baseplate on a routine post-op x-ray. They then ordered a CT and based off the scan, they observed a breach of the posterior medial cortex prompting the patient to be revised 3 days post-op. Attempts have been made and all available information has been provided.

  Patient problems: Periprosthetic fracture

  MAUDE report 50868561 ↗
• InjuryFeb 18, 2026Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION OF THE TIBIA TO ADDRESS UNKNOWN POST-OPERATIVE COMPLICATIONS. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Insufficient Information; Pain

  MAUDE report 24381738 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT KNEE SURGERY. APPROXIMATELY 3 YEARS POST-OP, THE PATIENT IS STILL EXPERIENCING PAIN. IMAGING DID NOT REVEAL ANY ISSUES WITH THE IMPLANT.

  Patient problems: Pain; Synovitis

  MAUDE report 23072651 ↗
• InjurySep 15, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY 11 MONTHS POST IMPLANTATION DUE TO THE TIBIA IMPLANT SUBSIDING. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 23057564 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 1 MONTH POST IMPLANTATION OF A RIGHT TOTAL KNEE ARTHROPLASTY THE PATIENT UNDERWENT A REVISION FOR FRACTURE OF THE TIBIAL PLATEAU THAT WAS CAUSED BY A FALL. THE CAUSE OF THE FALL IS UNKNOWN. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 22921514 ↗
• InjuryJul 7, 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: Joint Laxity

  MAUDE report 22416918 ↗
• InjuryMay 14, 2025Peeled/Delaminated; Loosening of Implant Not Related to Bone-Ingrowth; Peeled/Delaminated; 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 22021249 ↗
• InjuryMay 5, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 1.5 YEARS POST-OP, THE PATIENT UNDERWENT A REVISION DUE TO INSTABILITY, TIBIAL LOOSENING, AND PAIN. THE TIBIAL COMPONENT AND ARTICULAR SURFACE WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Joint Laxity; Pain

  MAUDE report 21961616 ↗
• InjuryOct 30, 2024Adverse 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: Discomfort

  MAUDE report 20567151 ↗
• InjuryApr 24, 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 SURGERY. APPROXIMATELY ONE YEAR LATER, THE PATIENT WAS REVISED DUE TO LOOSENING, PAIN, AND INSTABILITY. DURING THE SURGERY, THE SURGEON ALSO NOTED THAT THE FEMORAL COMPONENT WAS INTERNALLY ROTATED AND OVERSIZED. ONLY THE TIBIAL COMPONENT AND POLY WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 19172682 ↗
• InjuryApr 18, 2024Adverse 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: Abscess; Bacterial Infection; Erosion; Hematoma; Joint effusion; Pain

  MAUDE report 19133136 ↗
• InjuryApr 18, 2024Adverse 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: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 19133117 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A KNEE REVISION SURGERY ELEVEN MONTHS POST IMPLANTATION DUE TO METAL ALLERGY. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 19031181 ↗
• InjuryMar 29, 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 FOUR MONTHS POST-IMPLANTATION DUE TO TIBIAL TRAY LOOSENING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

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

  MAUDE report 19003949 ↗
• InjuryJan 3, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Failure of Implant; Insufficient Information; Pain

  MAUDE report 18437451 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT PRESENTED TO HCP OFFICE WITH INSTABILITY ISSUES APPROXIMATELY 6 MONTHS POST IMPLANTATION. THE TIBIAL IMPLANT AND ARTICULATING SURFACE WERE REVISED

  Patient problems: Failure of Implant

  MAUDE report 17548332 ↗
• InjuryAug 3, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT KNEE SURGERY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 8 MONTHS LATER DUE TO TIBIAL LOOSENING. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 17450503 ↗
• InjuryOct 4, 2022Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY THIRTEEN MONTHS POST IMPLANTATION DUE TO TIBIAL LOOSENING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 15536696 ↗
• InjuryJun 10, 2022Loosening 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 TIBIAL COMPONENT SUBSIDENCE APPROXIMATELY EIGHT (8) MONTHS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 14654422 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s)

  MAUDE report 12488130 ↗
• InjuryJul 6, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 1 MONTH LATER DUE TO TIBIAL SUBSIDENCE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 12121368 ↗
• InjuryJun 22, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN, MEDIAL TIBIA FRACTURE AND TIBIAL COMPONENT LOOSENING NINE (9) DAYS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 10178987 ↗

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