Persona® 42-5420-071-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00889024562882), received between Sep 23, 2020 and Sep 16, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 other recall cover devices cleared under the same FDA submission (K181947, K191625); 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Loosening of Implant Not Related to Bone-Ingrowth

  No further event information available at the time of this report.

  Patient problems: Aseptic loosening; Pain; Swelling/ Edema

  MAUDE report 50794030 ↗
• InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD A HEMATOMA EVACUATED APPROXIMATELY TWO WEEKS POST PROCEDURE. A SIGNIFICANT HEMATOMA WAS NOTED, EVACUATED, AND A DRAIN PLACED. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED.

  Patient problems: Hematoma

  MAUDE report 21720037 ↗
• InjurySep 27, 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: Pain; Swelling/ Edema

  MAUDE report 20321364 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED TWO (2) FALLS APPROXIMATELY SEVENTEEN (17) MONTHS AND FORTY (40) MONTHS FOLLOWING A RIGHT KNEE ARTHROPLASTY. THE PATIENT WAS PRESCRIBED ANTI-INFLAMMATORIES AND REHABILITATION WAS RECOMMENDED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS.

  Patient problems: Fall; Pain

  MAUDE report 19721746 ↗
• InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A KNEE ARTHROPLASTY. APPROXIMATELY 2 MONTHS POST-IMPLANTATION, THE PATIENT SUFFERED A MEDIAL TIBIAL FRACTURE. THE CAUSE OF THE FRACTURE IS UNKNOWN. SUBSEQUENTLY, THE PATIENT WAS REVISED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 19468545 ↗
• InjuryApr 23, 2024Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, ONE (1) YEAR AND SIX (6) MONTHS POST-IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE PAIN AND STIFFNESS. IMAGING SHOWED SUBSIDENCE OF THE TIBIAL COMPONENT AND A REVISION SURGERY WAS PERFORMED TO REPLACE THE AFFECTED COMPONENTS. ALL AVAILABLE INFORMATION HAS BEEN REPORTED.

  Patient problems: Failure of Implant; Insufficient Information; Pain

  MAUDE report 19168785 ↗
• InjuryMar 13, 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: Fall; Inflammation; Muscle/Tendon Damage; Pain; Swelling/ Edema

  MAUDE report 18895490 ↗
• InjuryJan 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY SEVEN WEEKS POST-IMPLANTATION DUE TO INFECTION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 18617187 ↗
• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN AND TENDERNESS OF THE PES ANSERINUS AND ILIOTIBIAL TRACT REQUIRING A CORTISONE INJECTION TWO YEARS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Bursitis; Loss of Range of Motion; Pain

  MAUDE report 14582584 ↗
• InjuryFeb 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE DAYS POST IMPLANTATION, THE PATIENT HAD PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF PAIN. DURING EVALUATION, THE SURGEON NOTED HEMARTHROSIS OF THE REPLACED JOINT. PATIENT WAS TREATED WITH PHYSICAL THERAPY AND A NARCOTIC PAIN MEDICATION. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 13568865 ↗
• InjuryFeb 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 11 WEEKS POST IMPLANTATION, THE PATIENT DEVELOPED SWELLING, INFLAMMATION, AND PES BURSITIS OF THE RIGHT KNEE. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH A CORTISONE INJECTION AND THE ISSUES RESOLVED. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Inflammation; Swelling/ Edema

  MAUDE report 13568784 ↗
• InjurySep 23, 2020Adverse 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: Bacterial Infection; Hematoma; Necrosis; Tissue Damage; Wound Dehiscence

  MAUDE report 10573006 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181947, K191625. One submission often covers many models, so check the product and lot details in each record.

• Z-2578-2026 · May 11, 2026 · Open, Classified
  Brand Name: Persona Revision Product Name: Persona Revision Trabecular Metal Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: