Persona® Partial Knee System 42-5182-004-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304818071), received between Sep 11, 2020 and Sep 11, 2020 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT UNILATERAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED A FALL THREE WEEKS POST OP. APPROXIMATELY 2 MONTHS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO DIFFICULTY AMBULATING, DECREASE IN ACTIVITY OF DAILY LIVING, PAIN, SWELLING, RADIOLUCENCY, A PERIPROSTHETIC FRACTURE, LOOSENING, SUBSIDENCE, AND POOR BONE QUALITY.

  Patient problems: Limited Mobility Of The Implanted Joint; Osteopenia/ Osteoporosis; Pain; Swelling

  MAUDE report 10524461 ↗

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