GENESIS II 71420790Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010209443), received between Mar 14, 2021 and Nov 25, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K951987); 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.

• InjuryNov 25, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED THE GNS II RESURF PAT 35MM PATELLA COMPONENT HAD LOOSENED FROM THE CEMENT IMPLANT INTERFACE AND THE GII DISHED INS SZ 7-8 9MM POLY WAS SLIGHTLY DEFORMED ON THE ANTERIOR EDGE, BUT NO SIGNIFICANT SIGNS OF WEAR. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE GII DISHED INS SZ 7-8 9MM AND THE GNS II RESURF PAT 35MM WERE EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Aseptic loosening; Failure of Implant

  MAUDE report 20774289 ↗
• MalfunctionJul 27, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING A TKA SURGERY, BOTH SURGEONS AND SALES REPRESENTATIVES REALIZED THE GII DISHED INS SZ 7-8 9MM WAS NOT REMAINING IN THE RECOMMENDED AND PROPER POSITION. THE SURGEON TRIED MULTIPLE TIMES FOR APPROXIMATELY 30 MINUTES UNTIL IT WAS TROUBLESHOOTED THAT THE COMPONENT MIGHT BE FAULTY. THEY TRIED THE XLPE COMPONENT OF 7-8 (9MM) AS THE TOURNIQUET TIME WAS RUNNING OUT AND THE SIZE 7 FEMUR AND SIZE 7 TIBIAL BASEPLATE WERE ALREADY SEATED. WITHIN 2 MINUTES, IT WORKED PERFECTLY. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17410970 ↗
• InjuryMar 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A REGISTER REPORT FROM ((B)(6)) THAT THERE WERE THIRTEEN REVISION SURGERIES PERFORMED TO REPLACE THE INSERT IMPLANT GENESIS II DISHED INS SIZE 7-8 9MM. THERE IS NO ADDITIONAL INFORMATION ABOUT THE HOSPITAL, PATIENT AND SURGERY DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478945 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K951987. One submission often covers many models, so check the product and lot details in each record.

• Z-1418-2022 · Jun 27, 2022 · Terminated
  (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.
• Z-2774-2020 · Jul 16, 2020 · Open, Classified
  Tibial knee prosthesis
• Z-2883-2018 · Aug 1, 2017 · Terminated
  GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
• Z-0573-2016 · Nov 9, 2015 · Terminated
  Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490 kn
• Z-0130-2014 · Oct 7, 2013 · Terminated
  GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic
• Z-0131-2014 · Oct 7, 2013 · Terminated
  GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic