NexGen® 5950-15-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024206977), received between Jul 20, 2022 and Feb 2, 2026 — classified as 2 injuries.

8 other recalls cover devices cleared under the same FDA submission (K023211, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT TOTAL KNEE REPLACEMENT AND SUBSEQUENTLY EXPERIENCED PAIN AND RESTRICTED MOBILITY IN HIS KNEE WHICH IS BECOMING WORSE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 24234040 ↗
• InjuryJul 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY. APPROXIMATELY 2.5 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS. THE PATIENT EXPRESSES EXTREME SATISFACTION WITHOUT FURTHER COMPLICATIONS.

  Patient problems: Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 15065902 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023211, K173057. One submission often covers many models, so check the product and lot details in each record.

• 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-1048-2018 · Nov 29, 2017 · Terminated
  CR-FLEX POR FEM F-L CR-FLEX POR FEM F-R MINUS CR-FLEX POR FEM G-L This device is indicated for patients with severe knee pain and disability
• Z-1046-2018 · Nov 29, 2017 · Terminated
  CR-FLEX OPT FEM C-R MINUS CR-FLEX OPT FEM D-L MINUS CR-FLEX OPT FEM D-R MINUS CR-FLEX OPT FEM E-L MINUS CR-FLEX OPT FEM E-R MINUS CR-FLEX OPT FEM F-L MINUS CR-FLEX OPT FEM F-R MINU
• Z-1047-2018 · Nov 29, 2017 · Terminated
  CR-FLEX OPT FEM C-L CR-FLEX OPT FEM C-R CR-FLEX OPT FEM D-L CR-FLEX OPT FEM D-R CR-FLEX OPT FEM E-L CR-FLEX OPT FEM E-R CR-FLEX OPT FEM F-L CR-FLEX OPT FEM F-R CR-FLEX OPT FEM G-L
• Z-1049-2018 · Nov 29, 2017 · Terminated
  CR-FLEX PCT FEM C-R MINUS CR-FLEX PCT FEM D-L MINUS CR-FLEX PCT FEM D-R MINUS CR-FLEX PCT FEM E-L MINUS CR-FLEX PCT FEM E-R MINUS CR-FLEX PCT FEM F-L MINUS CR-FLEX PCT FEM F-R MINU
• Z-1050-2018 · Nov 29, 2017 · Terminated
  CR-FLEX PCT FEM B-R CR-FLEX PCT FEM C-L CR-FLEX PCT FEM C-R CR-FLEX PCT FEM D-L CR-FLEX PCT FEM D-R CR-FLEX PCT FEM E-L CR-FLEX PCT FEM E-R CR-FLEX PCT FEM F-L CR-FLEX PCT FEM F-R
• Z-0831-2016 · Jan 11, 2016 · Terminated
  NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various size