Persona® Partial Knee System 42-5580-005-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304808560), received between Dec 10, 2020 and Nov 24, 2024 — classified as 4 injuries.

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.

• InjuryNov 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY. SUBSEQUENTLY 2.5 YEARS POST-OP, THE PATIENT WAS REVISED DUE TO PAIN. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 20768394 ↗
• InjuryJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY. SUBSEQUENTLY 2.5 YEARS POST-OP, THE PATIENT WAS REVISED DUE TO PAIN. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 19529252 ↗
• 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 17010141 ↗
• InjuryDec 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT A PATIENT EXPERIENCED SIGNIFICANT DISCOMFORT AND NUMBNESS IN THE MEDIAL ASPECT OF THE KNEE NINETEEN (19) MONTHS FOLLOWING RIGHT KNEE ARTHROPLASTY. A THE PATIENT WAS ADVISED TO CONTINUE REDUCING WEIGHT AND NO MEDICAL INTERVENTION WAS PERFORMED. ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Numbness; Pain

  MAUDE report 10987604 ↗

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