NexGen® 5950-15-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024207004), received between Feb 17, 2023 and Dec 3, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. APPROXIMATELY 8.5 YEARS POST-OP, THE PATIENT WAS REVISED DUE TO LOOSENING. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening

  MAUDE report 23705562 ↗
• InjuryOct 15, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS POST IMPLANTATION OF A PRIMARY RIGHT TOTAL KNEE ARTHROPLASTY THE PATIENT WAS REVISED DUE TO LOOSENING. NO ADDITIONAL INFORMATION IS AVAILABLE FROM THE REPORTER.

  Patient problems: Aseptic loosening

  MAUDE report 23291664 ↗
• MalfunctionFeb 17, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16396355 ↗

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-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-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-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-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-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