Persona® 42-5181-004-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304809789), received between Apr 8, 2020 and Mar 8, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INITIAL PARTIAL KNEE PROCEDURE, THE PROVISIONAL FRACTURED DURING EXTRACTION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13695565 ↗
• MalfunctionJan 10, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INITIAL PARTIAL KNEE PROCEDURE, THE PROVISIONAL FRACTURED DURING EXTRACTION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13203710 ↗
• MalfunctionJul 14, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE REP NOTICED A CRACK IN THE TRIAL AFTER THE DISINFECTING PROCESS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10270377 ↗
• MalfunctionApr 8, 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 Patient Involvement

  MAUDE report 9938344 ↗

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