Persona® Partial Knee System 42-5182-005-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304818170), received between Nov 6, 2023 and Jan 3, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (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.

• MalfunctionJan 3, 2025Unsealed Device Packaging; Difficult to Open or Remove Packaging Material; Unsealed Device Packaging; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE BLISTER LID WAS DIFFICULT FOR THE SURGEON TO OPEN, SO HE OPENED IT FORCEFULLY RESULTING IN THE IMPLANT FALLING OUT OF THE BLISTER AND DROPPING ONTO THE FLOOR, COMPROMISING IT'S STERILITY. IT WAS ALSO NOTED THAT THE BLISTER LID WAS NOT PROPERLY POSITION AS THE HEAT SEAL WAS NOT PROPERLY SEALED IN ONE OF THE CORNERS OF THE PACKAGING. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067079 ↗
• InjuryNov 6, 2023Adverse 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: Adhesion(s); Pain

  MAUDE report 18075091 ↗

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