Persona® 42-5568-062-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024556928), received between Feb 21, 2022 and Sep 16, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

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 9 most recent of 9 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 50793935 ↗
• 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 21719922 ↗
• InjurySep 17, 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: Bone Fracture(s); Fall; Pain; Swelling/ Edema

  MAUDE report 20238809 ↗
• InjurySep 17, 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: Bone Fracture(s); Fall; Pain; Swelling/ Edema

  MAUDE report 20238794 ↗
• 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 19721957 ↗
• 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 19721704 ↗
• InjuryMay 17, 2023Loosening 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; Pain; Radiolucent Lines

  MAUDE report 16948503 ↗
• InjuryAug 24, 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.

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

  MAUDE report 15286391 ↗
• 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 13568863 ↗

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: