NexGen® Legacy® Prolong® 5962-32-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00889024211131), received between Jun 9, 2021 and Jan 8, 2026 — classified as 11 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Joint Laxity; Pain

  MAUDE report 24006589 ↗
• InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 5 YEARS POST IMPLANTATION OF A RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS EXPERIENCING PAIN AND UNDERWENT A REVISION OF THE ARTICULAR SURFACE COMPONENT. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE AND NONE IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 22994430 ↗
• MalfunctionOct 16, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED DURING KNEE ARTHROPLASTY THAT THE ARTICULAR SURFACE COULD NOT BE ASSEMBLED WITH THE TIBIAL TRAY. ANOTHER ARTICULAR SURFACE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20465398 ↗
• MalfunctionMar 19, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE TIBIAL INSERT WOULD NOT SEAT IN THE TIBIAL TRAY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18937185 ↗
• InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE REPLACEMENT PERFORMED ON AN UNKNOWN DATE WITH UNKNOWN PRODUCT. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE LOOSENING AT THIS TIME ZIMMER BIOMET PRODUCT WAS IMPLANTED. APPROXIMATELY ONE YEAR, THREE MONTHS POST IMPLANTATION THE PATIENT HAD AN MRI THAT SHOWED A COLLECTION OF FLUID OVER THE MEDIAL ASPECT OF THE LEFT THE GASTROCNEMIUS MUSCLE SECONDARY TO A HEMATOMA. EDEMA WAS ALSO NOTED. THE PATIENT CONTINUED TO REPORT PAIN AND SWELLING. DIAGNOSTIC IMAGING COMPLETED ONE YEAR SIX MONTHS AFTER THE MRI SCAN SHOWED ¿EVIDENCE OF LOOSENING ABOUT THE CEMENT MANTLE OF THE TIBIAL COMPONENT¿. THE PATIENT HAS REPORTED SHE NOW HAS A LIFELONG INFECTION THAT HAS EATEN SOME OF THE BONE IN HER LEFT LEG AND IS REQUIRED STRONG ANTIBIOTICS FOR THE REST OF HER LIFE. PATIENT ALSO REPORTS ANTIBIOTICS HAVE IMPACTED HER RA CAUSING PERSISTENT PAIN AND DISCOMFORT AS WELL AS INSTABILITY AND NOW MUST USE A BRACE AND A CANE TO HELP SUPPORT HER GAIT. NO FURTHER DETAILS OR OUTCOMES HAVE BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Erosion; Hemothorax; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 18021862 ↗
• InjuryJul 24, 2023Unstable; Unstable

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

  Patient problems: Failure of Implant

  MAUDE report 17383723 ↗
• InjuryMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN, SWELLING AND SUSPECTED INFECTION APPROXIMATELY FIVE (5) WEEKS POST-OPERATIVELY. THE ARTICULAR SURFACE WAS REMOVED, HOWEVER, THE NEW ARTICULAR SURFACE WAS UNABLE TO BE SEATED, SO THE SURGEON OPTED TO REUSE THE ORIGINAL ARTICULAR SURFACE AFTER IT WAS STERILIZED. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. REVISION OPERATIVE NOTES NOTED THAT POOR HEALING, NECROSIS AND EFFUSION WERE FOUND. THE ORIGINAL ARTICULAR SURFACE WAS SOAKED SEVERAL TIMES IN HYDROGEN PEROXIDE AND IODOPHOR AND RINSED WITH SALINE BEFORE IT WAS RE-INSERTED. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Impaired Healing; Joint effusion; Necrosis; Pain; Swelling/ Edema

  MAUDE report 16896649 ↗
• MalfunctionApr 18, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A KNEE ARTHROPLASTY REVISION, THE ARTICULAR SURFACE COULD NOT BE ASSEMBLED WITH THE MATING IMPLANT. AFTER ATTEMPTING TO IMPLANT THE ARTICULAR SURFACE, THE IMPLANT WAS IDENTIFIED TO BE DAMAGED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16762830 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS REVISED DUE TO UNKNOWN REASONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16378013 ↗
• MalfunctionJul 26, 2022Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

  IT WAS REPORTED THAT AN ARTICULAR SURFACE WOULD NOT SEAT PROPERLY, AND THE SURGEON DECIDED TO REPLACE IT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15106111 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT'S ARTICULAR SURFACE WAS REVISED DUE TO SWELLING IN THE KNEE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Swelling/ Edema

  MAUDE report 14830925 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A LEFT KNEE MANIPULATION UNDER ANESTHESIA APPROXIMATELY THREE MONTHS POST-IMPLANTATION TO INCREASE RANGE OF MOTION. THE PATIENT REPORTS STILL EXPERIENCING PAIN, SWELLING, AND INSUFFICIENT RANGE OF MOTION, NECESSITATING CONTINUED TRIPS TO PHYSICAL THERAPY. NO REVISION PROCEDURE HAS BEEN REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 14205695 ↗
• InjurySep 7, 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 12432845 ↗
• InjuryJul 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Fall; Joint Dislocation

  MAUDE report 12216705 ↗
• InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FROM ADDITIONAL INFORMATION RECEIVED, THE PATELLA RESURFACING SURGERY WAS PERFORMED DUE TO PATELLA PAIN FROM PRESSURE ON A PREVIOUSLY UN-RESURFACED PATELLA.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 11968781 ↗

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.