NexGen® Complete Knee Solution 5962-30-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024665866), received between Aug 21, 2025 and Aug 21, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Positioning Failure” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THE TIBIAL LINER WOULD NOT MATE INTO THE TIBIAL TRAY. ANOTHER LINER WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22868118 ↗

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.