Persona® Natural Tibia® Trabecular Metal® 42-5300-067-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00889024510531), received between Sep 28, 2020 and Dec 15, 2025 — classified as 22 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (8 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.

• InjuryDec 15, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY THREE YEARS POST IMPLANTATION DUE TO PAIN AND TIBIAL LOOSENING. TIBIAL BASEPLATE AND BEARING WERE REVISED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 23801665 ↗
• InjurySep 11, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY. APPROXIMATELY 5 MONTHS POST-OP, THE PATIENT WAS REVISED DUE TO MEDIAL COLLAPSE AND LOOSENING. THE POLY AND TIBIAL COMPONENT WERE REVISED. THE SURGEON NOTED THAT PRIOR TO INITIAL IMPLANTATION, THE PATIENT PRESENTED WITH A VALGUS DEFORMITY AND THEY MAY HAVE OVERCORRECTED THE PATIENT TOO MUCH INTO VARUS CAUSING AN INCREASED LOAD ON THE MEDIAL TIBIA WITH LIKELY SOFT BONE DUE TO A PRE-OP DEFORMITY. THE SURGEON NOTED THAT THIS LIKELY CAUSED THE COLLAPSE AND IMPLANT TO LOOSEN. IN ADDITION, THE SURGEON THINKS THEY MAY HAVE UNDERSIZED THE TIBIAL COMPONENT.

  Patient problems: Aseptic loosening

  MAUDE report 23027976 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED. THIS EVENT WAS PREVIOUSLY REPORTED ON MFR # 0001822565-2025-00169.

  Patient problems: Pain

  MAUDE report 21596919 ↗
• InjuryFeb 19, 2025Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY SIX (6) WEEKS POST-IMPLANTATION, THE PATIENT FELL WHICH RESULTED IN LOOSENING OF THE TIBIAL COMPONENT. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY TO REPLACE THE AFFECTED COMPONENT WITHOUT COMPLICATION.

  Patient problems: Failure of Implant

  MAUDE report 21415120 ↗
• InjuryFeb 4, 2025Loss 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

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

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 21306803 ↗
• InjuryJan 23, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT HAS PAIN THAT HAS BEEN GETTING WORSE TO THE POINT SHE CAN ONLY WALK FOR THREE TO FIVE MINUTES. XX-RAYS SHOW OVERHANG OF THE TIBIA BASE PLATE MEDIALLY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Pain

  MAUDE report 21219829 ↗
• InjurySep 3, 2024Migration; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY ONE MONTH POST-IMPLANTATION DUE TO PERIPROSTHETIC FRACTURE AND SUBSIDENCE. THE TIBIAL TRAY WAS REMOVED AND REPLACED.

  Patient problems: Bone Fracture(s)

  MAUDE report 20131098 ↗
• InjuryJul 8, 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: Insufficient Information; Pain; Radiolucent Lines

  MAUDE report 19693902 ↗
• InjuryMay 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 KNEE SURGERY. APPROXIMATELY 3.5 YEARS POST-OP, THE PATIENT WAS REVISED DUE TO TIBIAL LOOSENING. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 19390525 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STUDY SUBJECT UNDERWENT A LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY FOUR MONTHS POST-IMPLANTATION, AN ADVERSE EVENT WAS ENTERED INTO THE STUDY FOR THE PATIENT FALLING AND SUBSEQUENT PAIN. DURING AN OFFICE VISIT, PATIENT REPORTED MILD PAIN WITH NO INSTABILITY. PATIENT WAS ASSIGNED A PRESCRIPTION TO HELP WITH THE PAIN. THE PATIENT COMPLETED THE STUDY ACCORDING TO PROTOCOL.

  Patient problems: Fall

  MAUDE report 18875424 ↗
• InjuryMar 5, 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: Insufficient Information

  MAUDE report 18835731 ↗
• InjuryJan 3, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY 15 MONTHS POST IMPLANTATION DUE TO MOBILITY OF THE POSTERIOR TIBIAL COMPONENT. THE SURGEON ALLEGED THAT THE EXPLANTED ARTICULAR SURFACE WAS WORN. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Synovitis

  MAUDE report 18438441 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION OF THE TIBIAL TRAY TO ADDRESS PAIN APPROXIMATELY SIXTEEN (16) MONTHS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 18425634 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY FOUR YEARS POST-IMPLANTATION DUE TO PAIN. THE TIBIAL INSERT AND TRAY WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Pain

  MAUDE report 18306519 ↗
• InjuryNov 8, 2023Migration; Migration

  IT WAS REPORTED THE PATIENT WAS REVISED FOR TIBIAL SUBSIDENCE AND PAIN APPROXIMATELY 4 MONTHS POST IMPLANTATION.

  Patient problems: Failure of Implant; Pain

  MAUDE report 18093455 ↗
• InjuryJun 19, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY 8 MONTHS POST IMPLANTATION. IT WAS NOTED THAT THE TIBIAL BASE PLATE WAS LOOSE DUE TO EXTREME POSTERIOR SLOPE. THE REVISING SURGEON STATED THE POSTERIOR SLOPE WAS AROUND 15 DEGREES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 17153644 ↗
• InjuryMar 28, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION TO ADDRESS TIBIAL PLATE SUBSIDENCE AFTER A FALL AND PAIN APPROXIMATELY ONE (1) MONTH POST-OPERATIVELY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Failure of Implant; Fall; Pain

  MAUDE report 16627118 ↗
• InjuryJan 10, 2022Migration; Migration

  IT WAS REPORTED THE PATIENT A UNDERWENT LEFT KNEE REVISION APPROXIMATELY ONE MONTH POST IMPLANTATION DUE TO TIBIAL TRAY SUBSIDENCE AND BONE FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 13210259 ↗
• InjuryAug 30, 2021Unstable; Unstable

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

  Patient problems: Failure of Implant

  MAUDE report 12385893 ↗
• InjuryJul 9, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY THREE MONTHS POST-IMPLANTATION DUE TO TIBIAL TRAY LOOSENING, SUBLUXATION, AND A TORN PATELLAR TENDON.

  Patient problems: Muscle/Tendon Damage; Pain

  MAUDE report 12144323 ↗
• InjuryFeb 9, 2021Osseointegration Problem; Migration; Osseointegration Problem; Migration

  REVISION OPERATIVE NOTES NOTE THAT A REVISION WAS PERFORMED FOR TIBIAL SUBSIDENCE. THE IMPLANTS WERE REMOVED AND NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED." MMI FINAL REPORT RECEIVED AND ATTACHED TO XRAYS WITHIN COMPLAINT. TIBIAL SUBSIDENCE AND RADIOLUCENCY CONFIRMED WITH QUESTIONABLE LOOSENING.

  Patient problems: Inadequate Osseointegration; Pain; Unequal Limb Length

  MAUDE report 11301570 ↗
• InjurySep 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED AN ALLERGIC REACTION AND BLISTERS ON THE SURGICAL SITE SUBSEQUENT TO BILATERAL TOTAL KNEE ARTHROPLASTY. TOPICAL MEDICATIONS WERE PRESCRIBED. OUTCOME HAS SINCE RESOLVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Reaction; Tissue Damage

  MAUDE report 10592486 ↗

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