NexGen® Complete Knee Solution 5962-22-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024665750), received between Jun 20, 2024 and Jul 9, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K042271, 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.

• MalfunctionJul 9, 2026Difficult to Insert

  IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT A POLYETHYLENE INSERT DID NOT LOCK INTO THE TIBIAL BASEPLATE. A SECOND INSERT OF THE SAME SIZE WAS OPENED INTRA-OPERATIVELY AND LOCKED PROPERLY. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25762090 ↗
• MalfunctionJun 20, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING SURGERY, THE POLY WAS NOT GETTING LOCKED ON THE TIBIAL BASE PLATE DESPITE REPEATED ATTEMPTS BY THE SURGEON. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19573936 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042271, K173057. One submission often covers many models, so check the product and lot details in each record.

• Z-1433-2025 · Feb 27, 2025 · Open, Classified
  NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10
• 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-0609-2011 · Apr 16, 2010 · Terminated
  NexGen Complete Knee Solution Stemmed tibial broach impactor, Catalog # 00-5977-011-00, Zimmer Inc., Warsaw, IN.