GENESIS II 71420106Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010205971), received between Jan 13, 2020 and Dec 16, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKJR SURGERY HAD BEEN PERFORMED ON (B)(6) 2012, THE PATIENT REPORTED AN UNKNOWN PROBLEM. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON (B)(6) 2021 TO REPLACE THE TIBIAL BASEPLATE, FEMORAL COMPONENT AND THE INSERT. ADDITIONALLY WAS OBSERVED THAT THERE WAS NO CEMENT ON THE BACK OF THE IMPLANT, INDICATING THAT THE PRODUCT HAD FAILED HAD THE CEMENT/IMPLANT INTERFACE. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Laceration(s); Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 13022580 ↗
• InjuryJan 13, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FEMORAL LOOSENING AND POST PERIPROSTHETIC FRACTURE. INTRAMEDULLARY NAILING OF LEFT FRACTURED DISTAL FEMUR WAS PERFORMED BY DR (B)(6) AT (B)(6) ON (B)(6)2019. THE POST OF THE POLY HAD BEEN INTENTIONALLY DAMAGED DURING THE FEMORAL NAILING, AS TO GAIN ACCESS TO THE IM CANAL WITHOUT REMOVING THE INSERT.

  Patient problems: Injury

  MAUDE report 9580052 ↗

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