Persona® 42-5420-083-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024562820), received between Feb 18, 2022 and Dec 14, 2022 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY WITH UNKNOWN PRODUCT. THE PATIENT WAS REVISED APPROXIMATELY 1.5 YEARS LATER DUE TO IMPLANT LOOSENING. AT THE 1 YEAR FOLLOW UP, THE PATIENT PRESENTED WITH LEFT LATERAL KNEE PAIN THAT RADIATES TO LOWER LEG. NARCOTICS WERE PRESCRIBED. AT THE 2 YEAR FOLLOW UP APPOINTMENT. A LARGE LEFT KNEE EFFUSION WAS PRESENT. LEFT KNEE ASPIRATION WAS COMPLETED IN THE OFFICE. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 15978596 ↗
• InjuryFeb 18, 2022Adverse 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 A REVISION PROCEDURE TWO YEARS POST IMPLANTATION DUE TO INSTABILITY. SUBSEQUENTLY, AT EIGHT MONTHS POST OP, THE PATIENT EXPERIENCED A SEVERE EFFUSION. ONE YEAR AND FIVE MONTHS LATER, THE PATIENT REPORTED SEVERE STIFFNESS AND PAIN. THE FINAL OUTCOME HAS BEEN REPORTED AS TOLERATED WITH NO MEDICAL INTERVENTION. THE PRODUCTS REMAIN IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Bacterial Infection; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 13559929 ↗

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: