Persona® 42-5181-007-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00880304809987), received between Mar 22, 2021 and Apr 14, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16742886 ↗
• MalfunctionJan 25, 2023Fracture; Fracture

  IT WAS REPORTED THE ARTICULAR SURFACE TRIAL CHIPPED WHILE THE HCP WAS TRYING TO TAKE IT OUT AFTER TRIAL REDUCTION WAS COMPLETED. NO PATIENT IMPACT. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16239774 ↗
• MalfunctionNov 21, 2022Fracture; Fracture

  THE ARTICULAR SURFACE TRIAL CHIPPED WHILE THE SURGEON WAS TRYING TO TAKE IT OUT AFTER TRIAL REDUCTION WAS COMPLETED. NO PATIENT HARM. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15838227 ↗
• MalfunctionApr 5, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11613261 ↗
• MalfunctionMar 22, 2021Fracture; Fracture

  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 0001825034.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11543302 ↗

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