NexGen® Legacy® Prolong® 5962-30-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024211025), received between Dec 17, 2019 and Sep 29, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 reports).

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.

• MalfunctionSep 29, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE DEVICE DID NOT FIT TO MATING COMPONENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15508837 ↗
• MalfunctionDec 17, 2019Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

  IT WAS REPORTED THAT AN ARTICULAR SURFACE WOULD NOT SEAT WITH THE TIBIAL COMPONENT DURING AN INITIAL KNEE PROCEDURE. WHEN THE ARTICULAR SURFACE WAS SEATED INTO THE TIBIAL COMPONENT, THERE WAS AN ABSENCE OF THE TYPICAL CLICK (NEITHER AUDIBLE NOR BASED ON PHYSICAL SENSATION) THAT USUALLY RESULTS FROM A SUCCESSFUL ARTICULAR SURFACE INSERTION. THE ARTICULAR SURFACE WAS THEN REMOVED AND, BASED ON VISUAL ASSESSMENT, A REPLACEMENT WAS REQUIRED. THERE WERE NO OBSERVED PROBLEMS WITH THE AS APPLICATION AND INSERTION TECHNIQUE DEPLOYED BY THE SURGEONS. A NEW ARTICULAR SURFACE WAS OPENED, AND WAS ABLE TO BE IMPLANTED INTO THE PATIENT WITHOUT ANY OF THE ABOVE MENTIONED PROBLEMS THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9480312 ↗

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.