Persona® Partial Knee System 42-5182-008-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304818545), received between May 28, 2021 and Mar 20, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Naturally Worn” (1 report).

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.

• InjuryMar 20, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Fall; Pain

  MAUDE report 16572459 ↗
• InjuryMay 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRIMARY LEFT PARTIAL KNEE WAS PERFORMED. SUBSEQUENTLY AT THE 1 YEAR CLINICAL VISIT PATIENT REPORTS MODERATE PAIN, DECLINE IN ADLS, DECLINE IN AMBULATING AND DISSATISFIED. PATIENT REMAINS IMPLANTED.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 11900827 ↗

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