NexGen® Legacy® Prolong® 5962-32-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024211148), received between Jan 7, 2020 and Dec 4, 2024 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2024Difficult to Insert; Difficult to Insert

  AFTER IMPLANTATION OF THE TIBIAL COMPONENT AND THE FEMORAL COMPONENT THE TRIALING WENT SMOOTHLY USING THE CORRESPONDING TRIAL MOLDS, BUT THE PROSTHESIS COULD NOT BE DRIVEN IN PROPERLY. A SECOND POLY WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT IMPACT OR HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20845833 ↗
• InjuryMar 29, 2024Unstable; Unstable

  IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT WAS REVISED DUE TO PAIN AND PROGRESSIVE INSTABILITY. THE TIBIAL INSERT AND PATELLA PROSTHESIS WERE REMOVED AND REPLACED.

  Patient problems: Pain

  MAUDE report 19005816 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Joint Laxity; Pain

  MAUDE report 16652325 ↗
• MalfunctionSep 28, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THE ARTICULAR SURFACE WOULD NOT LOCK ONTO THE TIBIAL IMPLANT. A SECOND ARTICULAR SURFACE WAS USED TO COMPLETE THE PROCEDURE. DELAY OF LESS THAN 15 MINUTES. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15498720 ↗
• InjuryJun 24, 2022Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. APPROXIMATELY TWO MONTHS POST IMPLANTATION, THE PATIENT EXPERIENCED LIMITED RANGE OF MOTION IN THE KNEE. EXAMINATION REVEALED THAT THE POLYETHYLENE BEARING COMPONENT HAD SHIFTED. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY TO EXCHANGE THE ARTICULAR SURFACE WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Loss of Range of Motion

  MAUDE report 14799979 ↗
• InjuryDec 16, 2021Unstable; Unstable

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY THREE YEARS AND THREE MONTHS POST IMPLANTATION DUE TO INSTABILITY. THE SURGEON REMOVED THE ARTICULAR SURFACE AND REPLACED IT WITH ANOTHER ONE THAT IS ONE SIZE BIGGER. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13017787 ↗
• MalfunctionJan 7, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN INITIAL TKA, THE SURGEON HAD DIFFICULTY IMPLANTING THE ARTICULAR SURFACE AND THUS, A NEW ONE HAD TO BE OPENED AND IMPLANTED. THE SECOND ARTICULAR SURFACE WAS IMPLANTED WITHOUT ANY ISSUES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Information

  MAUDE report 9557348 ↗

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.