GENESIS II 71420480Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010207845), received between Nov 29, 2018 and Apr 22, 2025 — classified as 4 injuries.

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

• InjuryApr 22, 2025Material Erosion; Material Erosion

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH IT WAS FOUND THAT THE (1) GII C/R ART INS SZ 1-2 9MM WAS WORN THROUGH COMPLETELY ON MEDIAL SIDE. THIS RESULTED IN THE COCR FEMORAL COMPONENT ARTICULATING AGAINST THE BASE PLATE. ALL IMPLANTS WERE REMOVED. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Impingement; Subluxation

  MAUDE report 21884706 ↗
• InjuryFeb 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A RIGHT TKA HAD BEEN PERFORMED ON (B)(6) 2009 WITH OSTEOARTHRITIS AS PRIMARY DIAGNOSIS, THE PATIENT REQUIRED A REVISION SURGERY ON (B)(6) 2019 DUE TO THE FOLLOWING DIAGNOSIS/COMPLICATION(S): COMPONENT DISSOCIATION, STIFFNESS AND IMPLANT FRACTURE. DURING THIS PROCEDURE, ALL THE KNEE PROSTHESIS COMPONENTS WERE EXPLANTED AND REPLACED WITH A SMITH+NEPHEW KNEE REVISION SYSTEM, AND THE PATELLA WAS RESURFACED. PER THE REGISTRY REPORT CONTENTS, IT IS NOT SPECIFIED WHICH OF THE EXPLANTED KNEE PROSTHESIS COMPONENTS FRACTURED. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A PRIMARY TKR SURGERY WITH A KNEE PROSTHESIS CONSTRUCT THAT INCLUDED A GENESIS II OXINIUM FEMORAL COMPONENTS AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Failure of Implant; Loss of Range of Motion

  MAUDE report 16396203 ↗
• InjuryJul 10, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED, THE SURGEON SUSPECTS METALLOSIS ON THE NATIVE PATELLA. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2022 TO EXPLANT AND REPLACED THE GII C/R ART INS SZ 1-2 9MM. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Metal Related Pathology

  MAUDE report 14973827 ↗
• InjuryNov 29, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO BONE FRACTURE. ONLY INSERT WAS REPLACED.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 8114676 ↗

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