Persona® Partial Knee System 42-5282-007-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304818484), received between Sep 9, 2021 and May 26, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Degraded” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REQUIRED AN IN-OFFICE ASPIRATION TO TREAT A LARGE EFFUSION SIXTEEN (16) DAYS FOLLOWING A RIGHT PARTIAL KNEE ARTHROPLASTY. 90CC OF BLOODY FLUID WAS ASPIRATED WITH NO SIGNS OF INFECTION. THE PATIENT PROGRESSED WITH NO FURTHER COMPLICATIONS AND WAS SATISFIED WITH JOINT FUNCTION AND PAIN MANAGEMENT.

  Patient problems: Joint effusion; Pain

  MAUDE report 17010129 ↗
• InjuryMay 25, 2023Naturally Worn; Naturally Worn

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

  Patient problems: Insufficient Information

  MAUDE report 17004254 ↗
• InjurySep 9, 2021Degraded; Unstable; Degraded; Unstable

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN, INSTABILITY, POLYETHYLENE DEGRADATION AND FEMORAL COMPONENT DISPLACEMENT APPROXIMATELY THREE (3) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis; Pain

  MAUDE report 12446408 ↗

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