Persona® Partial Knee System 42-5182-006-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304818293), received between May 1, 2025 and Nov 20, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K161592); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THE POLY WOULD NOT FIT INTO THE TIBIAL TRAY. NO DELAY OR PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION AVAILABLE FROM HCP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610187 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD A LEFT UNICOMPARTMENTAL KNEE ARTHROPLASTY. APPROXIMATELY 2 YEARS AND 8 MONTHS POST IMPLANTATION, BILATERAL KNEE PAIN WAS REPORTED, AND A CORTISONE INJECTION WAS ADMINISTERED TO THE STUDY KNEE. ALL PRODUCTS REMAIN IMPLANTED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 22374982 ↗
• MalfunctionMay 1, 2025Difficult to Insert; Difficult to Insert

  UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER: 1825034

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21945303 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161592. One submission often covers many models, so check the product and lot details in each record.

• Z-1238-2018 · Nov 29, 2017 · Terminated
  Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm block, Model Number:42-5399-035-09; (3) 10mm block, Model Number: 42-5399-035-10
• Z-0349-2018 · Jul 5, 2017 · Terminated
  Persona Partial Knee System, Size 8, Finishing Guide