Persona® Partial Knee System 42-5580-007-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304808584), received between Jan 18, 2022 and May 22, 2024 — classified as 2 injuries.

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

• InjuryMay 22, 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

  MAUDE report 19376746 ↗
• InjuryJan 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 AN INITIAL PARTIAL RIGHT KNEE PROCEDURE. DURING THE TRIAL REDUCTION, THE PATIENT SUSTAINED AN ANTERIOR CRUCIATE LIGAMENT INJURY. THE PATIENT REMAINED IN THE HOSPITAL FOR THREE DAYS. AT THE TIME OF THIS REPORT, NO ADDITIONAL MEDICAL INTERVENTION HAS BEEN REPORTED AND THE FINAL OUTCOME IS UNKNOWN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Damage to Ligament(s); Inflammation; Pain; Swelling/ Edema

  MAUDE report 13283100 ↗

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