Persona® Natural Tibia® Trabecular Metal® 42-5300-067-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00889024510548), received between Feb 7, 2020 and Sep 30, 2026 — classified as 18 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Difficult to Open or Remove Packaging Material

  It was reported that the internal sterile packet of a tibial implant was deformed and could not be removed from the outer package, and the device¿s sterility was considered compromised. There was no patient involvement. Attempts have been made and no further information has been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947521 ↗
• InjuryAug 6, 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 22726204 ↗
• InjuryJun 30, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 2.5 YEARS POST-OP, THE PATIENT WAS REVISED DUE TO TIBIAL LOOSENING AND PAIN. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 22357888 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT REPORTED PAIN AND SWELLING AND A RADIOGRAPHY INDICATED PERIPROSTHETIC FRACTURE OF THE TIBIAL BONE. PATIENT WAS REVISED APPROXIMATELY THREE WEEKS POST-IMPLANTATION DUE TO TIBIA BONE FRACTURE. THE TIBIAL TRAY AND INSERT WERE REMOVED AND REPLACED.

  Patient problems: Bone Fracture(s)

  MAUDE report 20682927 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN AND SWELLING POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Osteopenia/ Osteoporosis; Pain; Swelling/ Edema

  MAUDE report 18924927 ↗
• InjurySep 13, 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 ARTHROPLASTY REVISION TO ADDRESS PAIN AND TIBIAL LOOSENING APPROXIMATELY THIRTY-ONE (31) MONTHS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 17740285 ↗
• InjuryAug 9, 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 ONE YEAR POST IMPLANTATION DUE TO IMPLANT FRACTURE AND LOOSENING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Failure of Implant

  MAUDE report 17490818 ↗
• InjuryJul 13, 2023Unstable; Failure to Osseointegrate; Unstable; Failure to Osseointegrate

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY. APPROXIMATELY 8 MONTHS POST OP, THE PATIENT CONTINUED TO COMPLAIN OF PAIN AND INSTABILITY WITH HER KNEE 'GIVING OUT' AT TIMES. A BONE SCAN WAS COMPLETED WHICH REVEALED MICROMOTION IN THE TIBIAL COMPONENT WHICH APPEARS TO MEAN THAT THE PRESS-FIT PROSTHESIS DID NOT BOND TO THE BONE AS EXPECT. APPROXIMATELY 1 YEAR POST IMPLANTATION, THE PATIENT WAS REVISED. NO FURTHER INFORMATION OR DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Pain

  MAUDE report 17316717 ↗
• InjuryFeb 23, 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: Pain

  MAUDE report 16428909 ↗
• InjuryJul 13, 2022Unstable; Unstable

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. APPROXIMATELY FIFTEEN DAYS POST-IMPLANTATION, THE PATIENT FELT THEIR KNEE TWIST AND GIVE WAY. THE PATIENT UNDERWENT REVISION SURGERY OF THE TIBIAL COMPONENT ONE WEEK LATER WITHOUT COMPLICATION.

  Patient problems: Joint Laxity

  MAUDE report 15005018 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY HAD A MANIPULATION UNDER ANESTHESIA TWO MONTHS POST PROCEDURE DUE TO STIFFNESS. COMPONENTS REMAIN IMPLANTED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Loss of Range of Motion

  MAUDE report 14073731 ↗
• InjuryMar 23, 2022Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE TOTAL ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT BEGAN EXPERIENCING ONGOING HAMSTRING SPASMS AND CONTRACTURES. TEN DAYS POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY AND THE ANTERIOR ASPECT OF THE TIBIA WAS FOUND TO BE PROGRESSIVELY SUBSIDING. ALL COMPONENTS WERE EXCHANGED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: Cramp(s) /Muscle Spasm(s); Failure of Implant; Muscle/Tendon Damage; Osteopenia/ Osteoporosis

  MAUDE report 13861837 ↗
• InjuryFeb 24, 2022Migration or Expulsion of Device; Loosening of Implant Not Related to Bone-Ingrowth; Migration or Expulsion of Device; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 10 MONTHS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO PAIN, LOOSENING, AND SUBSIDENCE OF THE TIBIAL COMPONENT. ALL OF THE COMPONENTS WERE EXCHANGED WITHOUT COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH COMPETITOR PRODUCTS.

  Patient problems: Pain

  MAUDE report 13594693 ↗
• InjuryOct 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE SEVEN MONTHS POST IMPLANTATION DUE TO PAIN AND SWELLING. DURING REVISION PROCEDURE, SURGEON NOTED CLEAR SYNOVIAL FLUID, BUT THAT SYNOVIUM WAS INFLAMED AND SENT TISSUE BIOPSY¿S FOR EVALUATION. HE ALSO NOTED THAT THERE WAS VERY LITTLE BONE IN GROWTH IN THE TIBIAL BASE PLATE AND FEMUR PROSTHESIS. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 12561531 ↗
• InjuryJun 10, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE TIBIA COMPONENT REVISED FOR PAIN AND POSSIBLE LOOSENING. ARTICULAR SURFACE WAS ALSO REVISED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 11974577 ↗
• InjuryJun 3, 2021Migration; Migration

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT

  Patient problems: Pain

  MAUDE report 11929179 ↗
• InjuryApr 2, 2021Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY NINE MONTHS POST IMPLANTATION DUE TO TIBIAL TRAY SUBSIDENCE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 11608068 ↗
• InjurySep 25, 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 10586945 ↗
• InjuryFeb 7, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 2 MONTHS POST IMPLANTATION, THE PATIENT WAS EXPERIENCING STIFFNESS AND CONSEQUENTLY UNDERWENT A MANIPULATION UNDER ANESTHESIA WITH INJECTION OF THE RIGHT KNEE. APPROXIMATELY 2 WEEKS POST MANIPULATION, THE PATIENT'S SWELLING HAD REPORTEDLY RESOLVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 9681153 ↗

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