Persona® 42-5181-006-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00880304809901), received between Sep 4, 2020 and Apr 20, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2023Fracture; Fracture

  IT WAS REPORTED A PROVISIONAL FRACTURED DURING 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 16776205 ↗
• MalfunctionDec 21, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE INSTRUMENT FRACTURED WHEN TRIALING. THIS RESULTED IN A SURGICAL DELAY OF 5 MINUTES OR LESS. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16025529 ↗
• MalfunctionDec 7, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE INSTRUMENT FRACTURED WHEN TRIALING. THIS RESULTED IN A SURGICAL DELAY OF 5 MINUTES OR LESS. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15931767 ↗
• MalfunctionMar 30, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING KIT INSPECTION AT THE DISTRIBUTION WAREHOUSE, THE ARTICULAR SURFACE PROVISIONAL WAS IDENTIFIED TO BE FRACTURED. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11590143 ↗
• MalfunctionFeb 25, 2021Fracture; Fracture

  IT WAS REPORTED THE TIBIAL TRIAL FOR THE PPK CRACKED DURING THE CEMENTING PROCESS. THE LEG WAS IN FULL EXTENSION WITH THE AMBER THICKNESS GAUGE INSERTED BETWEEN THE FEMORAL IMPLANT AND THE TRIAL SURFACE TO CREATE MORE COMPRESSION FORCES ON THE CEMENT. UPON RETRIEVAL OF THE TRIAL, IT HAD CRACKED DURING THE CEMENTING PROCESS. NO PARTICLES FROM THE INSTRUMENT ENTERED NOR NEEDED TO BE RETRIEVED FROM THE PATIENT. THE DEVICE WAS CRACKED BUT REMAINED INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11380761 ↗
• MalfunctionDec 28, 2020Fracture; 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 1825034.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11083403 ↗
• MalfunctionSep 24, 2020Fracture; Fracture

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

  Patient problems: No Patient Involvement

  MAUDE report 10579908 ↗
• MalfunctionSep 4, 2020Fracture; Fracture

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

  Patient problems: No Patient Involvement

  MAUDE report 10494459 ↗

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