Persona® 42-5181-007-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00880304809963), received between Aug 3, 2021 and Jul 12, 2023 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17305369 ↗
• MalfunctionApr 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE INSTRUMENT BROKE INTO THREE PIECES DURING AN INITIAL SURGERY. THERE WAS NO SURGICAL DELAY. NO FOREIGN BODIES WERE RETAINED. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16775338 ↗
• MalfunctionMar 10, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16521472 ↗
• MalfunctionDec 5, 2022Fracture; Fracture

  IT WAS REPORTED THE PROVISIONAL FRACTURED DURING REMOVAL FROM THE JOINT SPACE FOLLOWING TRIALING AS PART OF A KNEE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15921863 ↗
• MalfunctionJun 17, 2022Fracture; Fracture

  IT WAS REPORTED THAT A FRACTURED PROVISIONAL WAS DISCOVERED IN STERILE PROCESSING. THERE WAS NO KNOWN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14734275 ↗
• MalfunctionMar 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE G 8MM BEARING TRIAL PLASTIC IS BROKEN. IMAGE PROVIDED IS UNCLEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13714557 ↗
• MalfunctionDec 14, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13000448 ↗
• MalfunctionSep 29, 2021Fracture; Fracture

  IT WAS REPORTED THAT A PROVISIONAL ARTICULAR SURFACE FRACTURED DURING THE TRAILING PROCESS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12548063 ↗
• InjuryAug 5, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE G 8MM BEARING TRIAL PLASTIC IS BROKEN. IMAGE PROVIDED IS UNCLEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12284412 ↗
• MalfunctionAug 3, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12266478 ↗

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