Persona® 42-5603-175-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887868250163), received between Dec 15, 2022 and Dec 15, 2022 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE SURGERY. SUBSEQUENTLY, THE PATIENT HAD SWELLING IN THE LEFT KNEE RESULTING IN A LEFT KNEE ASPIRATION APPROXIMATELY 2.5 YEARS LATER. NO FURTHER COMPLICATIONS OR RESULTS WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 15988299 ↗

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: