NexGen® 5972-16-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024215078), received between May 26, 2023 and May 26, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Wrong Label” (1 report).

105 other recalls cover devices cleared under the same FDA submission (K031061, K173057, K911572, K933785); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THAT DURING AN INITIAL TOTAL KNEE ARTHROPLASTY, THE SIZE OF THE FEMORAL COMPONENT DID NOT CORRESPOND TO THE SIZE ON THE PACKAGING. THE SURGEON PREPARED THE KNEE FOR A CERTAIN SIZE AND THE IMPLANT THAT WAS OPENED WAS ONE SIZE TOO LARGE, DESPITE INDICATING IT WAS THE CORRECT SIZE ON THE PACKAGE. NO PATIENT IMPACT OR ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION AND THE SURGERY WAS COMPLETED WITH A DIFFERENT IMPLANT OF THE CORRECT SIZE. DUE DILIGENCE IS IN PROCESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17011045 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031061, K173057, K911572, K933785. One submission often covers many models, so check the product and lot details in each record.

• Z-1608-2024 · Mar 28, 2024 · Open, Classified
  NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
• 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-1038-2018 · Nov 29, 2017 · Terminated
  LPS POROUS FEM IMPLANT SZ G-L LPS PRECOAT FEM IMPLANT SZ G-L This device is indicated for patients with severe knee pain and disability
• Z-1039-2018 · Nov 29, 2017 · Terminated
  LPS PRECOAT SRF HDN FEM SZ D-L LPS PRECOAT SRF HDN FEM SZ D-R LPS PRECOAT SRF HDN FEM SZ E-L LPS POROUS SRF HDN FEM SZ D-LT LPS POROUS SRF HDN FEM SZ E-LT This device is indicated
• Z-1040-2018 · Nov 29, 2017 · Terminated
  LPS PRECOAT FEM SIZE D-RT LPS PRECOAT FEM SIZE E-RT LPS POROUS FEM SIZE F-RT This device is indicated for patients with severe knee pain and disability
• Z-1041-2018 · Nov 29, 2017 · Terminated
  CR PRECOAT FEM COMP SIZE BMR CR PRECOAT FEM COMP SIZE C/R CR PRECOAT FEM COMP SIZE D/R CR PRECOAT FEM COMP SIZE E/R CR PRECOAT FEM COMP SIZE F/R CR PRECOAT FEM COMP SIZE G/L CR PRE
• Z-1030-2018 · Nov 29, 2017 · Terminated
  CR POR FEM HATCP SIZE E/L SIZE F/L Knee Prosthesis
• 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-1042-2018 · Nov 29, 2017 · Terminated
  CR OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM COMP SIZE D/L CR OPTION FEM COMP SIZE D/R CR OPTION FEM COMP SIZE E/L CR OPTION FEM COMP SIZE E/R CR OPTION FE
• Z-2115-2017 · Apr 28, 2017 · Terminated
  NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
• Z-1147-2016 · Jan 11, 2016 · Terminated
  Product 49 consists of all product under product code: JWH and same usage: Item no: 597206529 NEXGEN ALL-POLY PATELLA, 597206532 NEXGEN ALL-POLY PATELLA, 597206535 NEXGEN ALL-POL
• Z-1159-2016 · Jan 11, 2016 · Terminated
  Product 61 consists of all product under product code: JWH and same usage: Item no: 598003712 STD PRECOAT TIBIA PLATE S for use in total knee arthroplasty
• Z-1151-2016 · Jan 11, 2016 · Terminated
  Product 53 consists of all product under: product code: JWH and same usage: Item no: 597002501 NEXGEN PRECOAT PEG TIB PL 597002502 NEXGEN PRECOAT PEG TIB PL 597003501 NEXGEN PR
• Z-0835-2016 · Jan 11, 2016 · Terminated
  NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat Fem NexGen Knee LPS Porous Fem NexGen Knee LPS Precoat Fem prosthesis, knee, patellofemorotibial, semi-co

…and 90 more.