NexGen® Legacy® Prolong® 5962-22-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024210905), received between Apr 22, 2020 and Jun 19, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, FIVE (5) YEARS AND SIX (6) MONTHS POST-IMPLANTATION, THE POST OF THE ARTICULAR SURFACE FRACTURED. A REVISION SURGERY WAS PERFORMED TO REPLACE THE AFFECTED BEARING WITHOUT REPORTED COMPLICATION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 19567270 ↗
• MalfunctionApr 9, 2024Positioning Failure; Positioning Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19070797 ↗
• InjuryDec 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18419665 ↗
• InjuryMar 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, EIGHT (8) DAYS POST-IMPLANTATION, THE PATIENT PRESENTED WITH PAIN AND IT WAS REVEALED THAT THE ARTICULAR SURFACE HAD DISLOCATED. THE PATIENT UNDERWENT REVISION SURGERY THE NEXT DAY TO REPLACE THE BEARING COMPONENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Joint Dislocation; Pain

  MAUDE report 16477416 ↗
• MalfunctionApr 22, 2020Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

  IT WAS REPORTED THAT THE DEVICE INSERT HAD A MANUFACTURING DEFECT. THIS OCCURRED DURING A CASE, BUT THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9987977 ↗

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.