NexGen® Legacy® Prolong® 5962-32-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024211155), received between Feb 28, 2022 and Apr 15, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TKA. SUBSEQUENTLY, THEY HAD A REVISION APPROXIMATELY 7 YEARS AND 2 MONTHS POST-IMPLANTATION DUE TO PROGRESSIVELY INCREASING INSTABILITY. THE SURGICAL TECHNIQUE WAS UTILIZED; THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity

  MAUDE report 24888246 ↗
• MalfunctionJul 7, 2025Positioning Failure; Positioning Failure

  NO ADDITIONAL INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22415156 ↗
• InjuryFeb 1, 2023Unstable; Unstable

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Joint Laxity

  MAUDE report 16279070 ↗
• InjuryJun 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION ARTICULAR SURFACE EXCHANGE SURGERY DUE TO A MIGRATED POLYETHYLENE BEARING. APPROXIMATELY ONE MONTH POST-IMPLANTATION, THE PATIENT AGAIN EXPERIENCED A SHIFTED ARTICULAR SURFACE AND REQUIRED REVISION SURGERY FOR A SECOND TIME. ALL COMPONENTS WERE EXCHANGED FOR A DIFFERENT PROSTHESIS SYSTEM WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 14800696 ↗
• InjuryJun 24, 2022Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION ARTICULAR SURFACE EXCHANGE SURGERY DUE TO A MIGRATED POLYETHYLENE BEARING. APPROXIMATELY ONE MONTH POST-IMPLANTATION, THE PATIENT AGAIN EXPERIENCED A SHIFTED ARTICULAR SURFACE AND REQUIRED REVISION SURGERY FOR A SECOND TIME. ALL COMPONENTS WERE EXCHANGED FOR A DIFFERENT PROSTHESIS SYSTEM WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 14800670 ↗
• InjuryFeb 28, 2022Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY SIX YEARS POST-IMPLANTATION FOR AN UNKNOWN REASON. THE TIBIAL INSERT WAS REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13620753 ↗

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.