Persona® 42-5420-067-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024562875), received between Feb 4, 2021 and Jul 10, 2024 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 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; Radiolucent Lines

  MAUDE report 19709197 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY FOLLOWED BY A REVISION 7 YEARS LATER DUE TO ASEPTIC LOOSENING. SUBSEQUENTLY, THE PATIENT BEGAN TO EXPERIENCE PAIN OVER THE PES BURSA AND WAS INITIAL PRESCRIBED NSAIDS AND PHYSICAL THERAPY FOR PES ANSERINUS BURSITIS. THE PATIENT RECEIVED A CORTISONE INJECTION SIXTEEN MONTHS POST REVISION. ALL IMPLANTS REMAIN IN PLACE AND AT THE TWO-YEAR FOLLOW-UP, REPORTS NO PAIN.

  Patient problems: Bursitis; Pain

  MAUDE report 19139790 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT RIGHT KNEE A TWO STAGE REVISION FOR INFECTION. SUBSEQUENTLY, APPROXIMATELY 7 MONTHS LATER THE PATIENT BEGAN TO HAVE INTERMITTENT PAIN AND SWELLING AND 2 YEARS FIVE MONTHS REPORTED AN INCREASE IN PAIN AND WAS PRESCRIBED PHYSICAL THERAPY. ALL IMPLANTS REMAIN IN PLACE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 19139735 ↗
• InjuryApr 13, 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: Bursitis; Pain

  MAUDE report 16732400 ↗
• InjuryMay 26, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY. SUBSEQUENTLY, THE PATIENT FELL AND REPORTS ONGOING PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Fall; Pain

  MAUDE report 14516294 ↗
• InjuryMar 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT REPORTED COUGH, SHORTNESS OF BREATH, RIB PAIN, BACK PAIN, NAUSEA/VOMITING, AND DIARRHEA WHICH PROGRESSED TO DIFFICULTY BREATHING AND THE PATIENT WAS HOSPITALIZED APPROXIMATELY THREE WEEKS POST IMPLANTATION WITH PULMONARY EMBOLISM AND PNEUMONIA. THESE ISSUES WERE RESOLVED APPROXIMATELY SEVEN MONTHS LATER WITH MEDICAL TREATMENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Embolism/Embolus; Pneumonia

  MAUDE report 13942608 ↗
• MalfunctionFeb 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11282956 ↗

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: