Persona® 42-5181-006-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304809918), received between Oct 1, 2021 and May 10, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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.

• MalfunctionMay 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE INSTRUMENT WAS DISCOVERED FRACTURED AS IT WAS REMOVED FROM THE TRAY. NO HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19284875 ↗
• MalfunctionAug 31, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A PARTIAL KNEE ARTHROPLASTY, THE ARTICULAR SURFACE PROVISIONAL FRACTURED UPON INSERTION. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATION. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17661048 ↗
• MalfunctionOct 1, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE WAS FRACTURED DURING SURGERY. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12562050 ↗

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