Natural-Knee® 6420-00-210Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024259355), received between Jun 6, 2022 and Jan 27, 2023 — classified as 2 injuries.

7 other recalls cover devices cleared under the same FDA submission (K023528, K173057); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Pulmonary Embolism

  MAUDE report 16254699 ↗
• InjuryJun 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY AND PRESCRIBED MEDICATION TWO DAYS POST-OP. SUBSEQUENTLY, APPROXIMATELY A WEEK LATER, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH ATRIAL FIBRILLATION AND A PULMONARY EMBOLISM. THE ISSUES WERE RESOLVED BY THE FOLLOWING DAY WITH NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Atrial Fibrillation; Pulmonary Embolism

  MAUDE report 14601407 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023528, K173057. One submission often covers many models, so check the product and lot details in each record.

• Z-2092-2023 · May 19, 2023 · Terminated
  NexGen Precoat Stemmed Tibial Plate Size 5
• Z-0321-2020 · Oct 10, 2019 · Terminated
  Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100 00522000200 00522000300 00522000400 00522006304 00522006504 00522006600 00522006800
• Z-1485-2009 · Mar 18, 2009 · Terminated
  Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 0, TIB B/PL, for cemented use only, sterile, Zimmer, Warsaw, IN; Model Number: 6420-01-200. The Natura
• Z-1484-2009 · Mar 18, 2009 · Terminated
  Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Left, Size 0, TIB B/PL, for cemented use only, sterile, Zimmer, Warsaw, IN; Model Number: 6420-00-200. The Natural
• Z-1483-2009 · Mar 18, 2009 · Terminated
  Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 00, for cemented use only, sterile, Zimmer, Warsaw, IN; Model Number: 6420-01-002. The Natural-Knee II
• Z-1482-2009 · Mar 18, 2009 · Terminated
  Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Left, Size 00, for cemented use only, sterile, Zimmer, Warsaw, IN; Model Number: 6420-00-002. The Natural-Knee II
• Z-0871-2009 · Nov 25, 2008 · Terminated
  Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 3, For cemented use only, sterile, Zimmer, Warsaw, IN; REF 6420-01-230. The modular cemented tibial ba