Persona® Partial Knee System 42-5282-006-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304818378), received between Sep 15, 2022 and May 20, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT UNILATERAL KNEE ARTHROPLASTY. SUBSEQUENTLY 5 MONTHS POST-OP, THE PATIENT RECEIVED A STEROID INJECTION TO THE RIGHT KNEE FOR PES BURSITIS FOLLOWING AN INCIDENT OF PAIN AFTER BENDING DOWN TO GET INTO A PLANK POSITION. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bursitis; Pain

  MAUDE report 19351212 ↗
• MalfunctionSep 15, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN INITIAL PARTIAL KNEE ARTHROPLASTY, THE ARTICULAR SURFACE WOULD NOT SEAT WITH THE TIBIAL TRAY. A SECOND BEARING WAS USED AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATION. THERE WAS NO SURGICAL DELAY NOR PATIENT IMPACT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432387 ↗

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