NexGen® Legacy® Prolong® 5962-40-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024211247), received between Jul 21, 2020 and Dec 9, 2024 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY FORTY-SIX MONTHS POST-IMPLANTATION DUE TO LIMITED FLEXION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Loss of Range of Motion

  MAUDE report 20878679 ↗
• InjuryApr 16, 2024Unstable; Unstable

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

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 19117687 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY 4 YEARS POST IMPLANTATION DUE TO INSTABILITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity

  MAUDE report 17653025 ↗
• MalfunctionAug 4, 2022Positioning Failure; Migration; Positioning Failure; Migration

  IT WAS REPORTED THAT A PATIENT WAS REVISED DUE TO THE LOCKING PIN OF THE ARTICULAR SURFACE BACKING OUT. DURING THE PRIMARY CASE, PROPER SEATING OF THE ARTICULAR SURFACE WAS ASCERTAINED. AFTER SURGERY THE PATIENT WAS FEELING PRICKING PAIN OVER MEDIAL ASPECT OF LEFT KNEE AND A POST OPERATIVE X-RAY SHOWED THAT THE LOCKING PIN OF ARTICULAR SURFACE WAS BACKING OUT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 15164364 ↗
• MalfunctionFeb 3, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE INSERT WOULD NOT LOCK AND FIT PROPERLY WHEN INSTALLED DURING THE PROCEDURE FOLLOWING THE PROPER SURGICAL TECHNIQUE AND TOOLS. THERE WAS NO SURGICAL DELAY. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13444117 ↗
• MalfunctionDec 6, 2021Positioning Failure; Positioning Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12933552 ↗
• InjurySep 21, 2021Adverse 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: Pain

  MAUDE report 12505314 ↗
• InjuryJun 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS IDENTIFIED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THIS COMPLAINT HAS BEEN REPORTED UNDER 0002648920-2021-00160.

  Patient problems: Damage to Ligament(s)

  MAUDE report 12024632 ↗
• MalfunctionJul 21, 2020Difficult to Insert; Device Damaged Prior to Use; Difficult to Insert; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE BEARING DID NOT LOCKING PROPERLY. UPON FURTHER INSPECTION, IT WAS NOTED THAT THE LOCKING MECHANISM OF THE BEARING WAS DEFORMED. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10302799 ↗

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.