Persona® Partial Knee System 42-5182-004-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304818057), received between Sep 8, 2020 and Aug 19, 2026 — classified as 3 injuries, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  It was reported from a clinical study that the patient experienced moderate to severe knee pain and stiffness following an initial left partial knee arthroplasty. This was mentioned at follow-up visits through approximately five years post-implantation, symptoms were managed with acetaminophen and nonsteroidal anti-inflammatory drugs. The implants remained in place without further intervention. Attempts have been made and no further information has been provided.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 50332421 ↗
• MalfunctionApr 2, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PARTIAL ARTICULAR SURFACE WOULD NOT SEAT IN THE TIBIAL TRAY AS PART OF AN INITIAL PARTIAL KNEE ARTHROPLASTY. THE PROCEDURE WAS COMPLETED USING ANOTHER ARTICULAR SURFACE THAT WAS AVAILABLE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19028871 ↗
• InjuryFeb 5, 2021Unstable; Noise, Audible; Unstable; Noise, Audible

  IT WAS REPORTED THAT PATIENT UNDERWENT LEFT UNILATERAL KNEE ARTHROPLASTY. AT THE ONE & TWO YEAR VISITS, THE PATIENT REPORTS MODERATE PAIN, NOISE, AND FEELING OF INSTABILITY. THE PATIENT WAS DIAGNOSED WITH PES ANSERINE BURSITIS WITHOUT REPORTED TREATMENT OR INTERVENTION AND A NEUROMA FOR WHICH THE PATIENT RECEIVED ORAL MEDICATION FOR NERVE PAIN. AT THE TWO YEAR VISIT, THE PATIENT REPORTED PERSISTENT PAIN WITH NO CLINICAL INDICATION OF DEVICE COMPLICATIONS. THE PATIENT WAS INSTRUCTED TO RETURN IN 5 YEARS.

  Patient problems: Pain; Swelling

  MAUDE report 11285852 ↗
• InjurySep 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 10501529 ↗

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