Persona® Partial Knee System 42-5182-006-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304818330), received between Sep 30, 2026 and Sep 30, 2026 — 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 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient had an initial left partial knee arthroplasty performed. Approximately 6-8 weeks postop, the patient underwent an open reduction internal fixation. The initial partial knee implants remained intact. About 2 years later, the patient swung his club while golfing and felt a pop in his knee which gave out. The surgeon told the patient at follow-up that he will need to be converted to a total knee. Further follow up with the patient indicates that a revision to a total knee arthroplasty was performed approximately a month after that. During the revision, bone filler was applied to a periprosthetic fracture. No intraop or further complications have been reported. The patient currently has no complaints with the new knee. No further information has been provided.

  Patient problems: Joint Laxity; Periprosthetic fracture

  MAUDE report 50946491 ↗

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