NexGen® Legacy® Prolong® 5962-40-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024211254), received between Sep 6, 2022 and Jan 28, 2026 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS PATIENT WAS REVISED APPROXIMATELY SIX YEARS POST IMPLANTATION DUE TO ARTHROLYSIS AROUND THE NATIVE PATELLA. THE SURGEON REVISED THE ARTICULAR SURFACE WHILE REMOVING SCAR TISSUE PREDOMINANTLY AROUND THE PATELLA TO IMPROVE PATELLA TRACKING AND INCREASE RANGE OF MOTION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 24199845 ↗
• MalfunctionJun 6, 2023Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

  IT WAS REPORTED THAT THE POLYETHYLENE IMPLANT DID NOT FIT INTO THE METALLIC TIBIAL BASE. SEVERAL ATTEMPTS WERE MADE WITH NO SUCCESS. ANOTHER ARTICULAR SURFACE WAS USED TO COMPLETE THE SURGERY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE, HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17073375 ↗
• InjurySep 6, 2022Unstable; Unstable

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE EIGHT YEARS POST IMPLANTATION DUE TO PAIN, INSTABILITY AND IMPLANT FRACTURE. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 15364231 ↗

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.