Persona® Natural Tibia® Trabecular Metal® 42-5300-071-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00889024510555), received between Mar 16, 2021 and Aug 24, 2026 — 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.

• InjuryAug 24, 2026Loosening of Implant Not Related to Bone-Ingrowth

  It was reported that a patient underwent a knee arthroplasty approximately 3.5 months post implantation due to tibial pain and loosening. It was reported that no further information is available.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 50411673 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s)

  MAUDE report 23393178 ↗
• InjuryOct 16, 2025Implant subsidence; Implant subsidence

  NO ADDITIONAL INFORMATION TO REPORT.

  Patient problems: Insufficient Information; Pain

  MAUDE report 23316562 ↗
• InjuryApr 28, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NO ADDITIONAL INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Failure of Implant; Pain; Radiolucent Lines; Swelling/ Edema

  MAUDE report 21923469 ↗
• InjuryApr 22, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN AND TIBIAL LOOSENING APPROXIMATELY THREE (3) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 21885040 ↗
• InjuryMar 5, 2025Migration; Migration

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

  Patient problems: Failure of Implant

  MAUDE report 21525768 ↗
• InjuryJan 31, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS PERIPROSTHETIC FRACTURE OF THE PATELLA AND TIBIAL COMPONENT SUBSIDENCE APPROXIMATELY THREE (3) WEEKS POST-OPERATIVELY. ALL COMPONENTS WERE REMOVED AND THE PATELLA WAS SECURED WITH A PLATE AND SCREWS. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 21284943 ↗
• InjuryJun 25, 2024Adverse 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 ONE YEAR POST-IMPLANTATION DUE TO TIBIAL PAIN. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Pain

  MAUDE report 19605679 ↗
• InjuryNov 16, 2023Migration; Migration

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

  Patient problems: Pain

  MAUDE report 18154714 ↗
• InjuryOct 10, 2023Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM PAIN, TIBIAL IMPLANT LOOSENING, ANTERIOR AND POSTERIOR TIBIAL RADIOLUCENCY, AND ANTERIOR SUBSIDENCE. PATIENT ALSO EXPERIENCED MODERATE PAIN AT 6 MONTHS POSTOP. NO FURTHER DETAILS OR OUTCOMES HAVE BEEN PROVIDED.

  Patient problems: Failure of Implant; Pain; Radiolucent Lines

  MAUDE report 17903858 ↗
• InjuryJun 28, 2023Loss 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 17220506 ↗
• InjuryMay 3, 2023Fracture; Osseointegration Problem; Fracture; Osseointegration Problem

  IT WAS REPORTED A PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY. AT 3 MONTHS POST OP, THE PATIENT WAS PAIN FREE WITH 120 DEGREES FLEXION. APPROXIMATELY 4 MONTHS POST IMPLANTATION, THE PATIENT PRESENTED WITH KNEE PAIN. THE ORIGINAL REASON FOR REVISION WAS FOR SUSPECTED INFECTION, HOWEVER, THE SURGEON MENTIONED THE KNEE DID NOT LOOK INFECTED WHEN REMOVING THE PROSTHESIS. THE SURGEON TOOK 6 SWABS, 3 ON DISTAL FEMUR AND 3 ON PROXIMAL TIBIA. WHEN REMOVING THE TIBIA, IT WAS NOTED THAT THE MEDIAL TM PEG HAD SNAPPED PRIOR TO ATTEMPTS TO REMOVE. THE BONE INGROWTH ON THE UNDERSIDE OF TM TIBIA WAS SMALL. THE PEG THAT WAS LEFT IN PATIENT HAD BONE INGROWTH. IT WAS NOTED THAT THE MEDIAL TM PEG IS NOT PERPENDICULAR TO THE BASEPLATE IN X-RAYS. ADDITIONALLY, METAL DEBRIS SEEN IN X-RAYS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Pain; Unspecified Infection

  MAUDE report 16860487 ↗
• InjuryMar 16, 2023Migration; Migration

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

  Patient problems: Bacterial Infection; Failure of Implant; Joint effusion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 16553274 ↗
• InjuryMar 13, 2023Adverse 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

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 16528628 ↗
• InjuryOct 24, 2022Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY 1 MOTH POST IMPLANTATION DUE TO PAIN AND TIBIAL SUBSIDENCE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 15659294 ↗
• InjuryNov 12, 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: Failure of Implant

  MAUDE report 12802837 ↗
• InjuryOct 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A CLINICAL STUDY THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. ONE WEEK POST IMPLANTATION, THE PATIENT DEVELOPED WOUND DRAINAGE COMPLICATIONS REQUIRING APPLICATION OF A KNEE IMMOBILIZER. TWO MONTHS POST IMPLANTATION THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO STIFFNESS AND LIMITED FLEXION. THE PATIENT CONTINUED TO REPORT STIFFNESS AND WAS PLACED IN A SPLINT. ONE MONTH AFTER THE MANIPULATION UNDER ANESTHESIA, THE PATIENT UNDERWENT AN OPEN RESECTION FOR SCAR TISSUE DUE TO ARTHROFIBROSIS. THE PATIENT WAS ULTIMATELY REVISED APPROXIMATELY TEN MONTHS POST IMPLANTATION DUE TO ONGOING PAIN, DIFFICULTY AMBULATING, AND ARTHROFIBROSIS. DURING THE REVISION, EXTENSIVE SCAR TISSUE WAS NOTED AS WELL AS A PSEUDO MENISCUS FORMATION CIRCUMFERENTIALLY AROUND THE JOINT. THE FEMORAL COMPONENT AND ARTICULAR SURFACE WERE EXCHANGED AND THE PATELLA WAS RESURFACED WITHOUT COMPLICATION. THE TIBIAL COMPONENT REMAINS IMPLANTED.

  Patient problems: Impaired Healing; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 12576662 ↗
• InjuryAug 6, 2021Migration; Migration

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

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

  MAUDE report 12287906 ↗
• InjuryJun 23, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY 16 MONTHS POST IMPLANTATION DUE TO PAIN AND LOOSENING. FEMUR AND PATELLA REMAINED IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis; Pain

  MAUDE report 12048682 ↗
• InjuryJun 7, 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: Pain

  MAUDE report 11947953 ↗
• InjuryMay 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY APPROXIMATELY 1.5 YEARS AGO. SUBSEQUENTLY, THE PATIENT HAS BEEN EXPERIENCING PAIN AND SWELLING SINCE HER PROCEDURE. SHE HAS UNDERWENT TWO MANIPULATIONS ON UNKNOWN DATES, REMOVING SCAR TISSUE WITH NO RELIEF. PATIENT HAD METAL ALLERGY TESTING AND IS HIGHLY REACTIVE TO NICKEL. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 11768808 ↗
• InjuryMar 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA APPROXIMATELY TWO MONTHS AND ONE-WEEK POST IMPLANTATION DUE TO ARTHROFIBROSIS. THE PATIENT COMPLETED THE STUDY SATISFIED APPROXIMATELY ONE YEAR AND FIVE MONTHS LATER WITHOUT FURTHER COMPLICATIONS REQUIRING INTERVENTION. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 11495868 ↗

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