Persona® Partial Knee System 42-5580-006-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00880304808492), received between May 28, 2020 and Sep 30, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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 5 most recent of 5 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 50946334 ↗
• InjuryMay 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRIMARY LEFT PARTIAL KNEE WAS PERFORMED. SUBSEQUENTLY AT THE 1 YEAR CLINICAL VISIT PATIENT REPORTS MODERATE PAIN, DECLINE IN ADLS, DECLINE IN AMBULATING AND DISSATISFIED. PATIENT REMAINS IMPLANTED.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 11901070 ↗
• MalfunctionApr 13, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PPK FEMORAL COMPONENT PREPARED FOR A UKA HAD DAMAGED POUCHES INSIDE OF THE STERILE TRAY. THIS WAS FOUND WHEN THE PACKAGE WAS OPENED. SUBSEQUENTLY, ANOTHER PPK FEMORAL COMPONENT WAS USED TO COMPLETE THE PROCEDURE. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11657775 ↗
• InjuryJul 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THE PATIENT HAD AN INITIAL LEFT PARTIAL TKR, AND SUBSEQUENTLY WAS REVISED APPROXIMATELY 20 MONTHS LATER DUE TO PAIN, SWELLING, AND METAL ALLERGY.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Pain; Reaction; Swelling; Swelling/ Edema

  MAUDE report 10232789 ↗
• InjuryMay 28, 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: Inflammation; Pain; Reaction; Swelling

  MAUDE report 10096157 ↗

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