Persona® 42-5558-071-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024557208), received between Feb 22, 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 15978594 ↗
• InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS EXPERIENCING MILD SWELLING, STIFFNESS AND PES ANSERINE TENDERNESS APPROXIMATELY 3 MONTHS POST IMPLANTATION. MILD BLOODY DRAINAGE AND PREINCISIONAL DRAINAGE WAS ALSO NOTED. PATIENT WAS TREATED WITH VOLTAREN TOPICAL GEL AND PHYSICAL THERAPY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Inflammation; Pain; Swelling/ Edema

  MAUDE report 13576747 ↗

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: