GENESIS II 71420042Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010205643), received between Jun 7, 2022 and Jan 11, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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.

• InjuryJan 11, 2024Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT, AFTER A TKA REVISION SURGERY WAS PERFORMED ON 2002, THE PATIENT EXPERIENCED SEVERE PAIN WHEN STANDING. THE PATIENT WENT TO EMERGENCY AND WAS ADMITTED TO HOSPITAL. AN MRI SCAN REVEALED A LARGE CYST ON THE LATERAL FEMORAL CONDYLE, AND IT WAS NOTICED THAT THE FEMORAL COMPONENT STARTED TO COLLAPSE. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A SECOND REVISION SURGERY ON (B)(6) 2023, IN WHICH THE GNS II POR FEM SIZE 6 LEFT WAS CONFIRMED TO BE LOOSE. A NEW LEGION FEMORAL COMPONENT WAS PLACED, ALONG WITH A NEW TKA SYSTEM. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Cyst(s); Failure of Implant; Implant Pain; Inadequate Osseointegration; Pain

  MAUDE report 18499407 ↗
• InjuryJun 7, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED IN 2018, THE PATIENT EXPERIENCED PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 IN ORDER TO SOLVE THIS ADVERSE EVENT. DURING THE SURGERY, IT WAS DISCOVERED THAT THE GNS II POR FEM SIZE 6 LEFT HAD NO BONE ON/IN-GROWTH, WHILE THE GNS II CMT TIB SIZE 5 {} LEFT WAS FOUND TO BE WELL FIXED AND IT WAS REMOVED PER USUAL. BOTH GNS II POR FEM SIZE 6 LEFT AND GNS II CMT TIB SIZE 5 {} LEFT WERE REVISED WITH SIMILAR SIZED LEGION REVISION WITH 220 STEMS, AND THE PATELLA WAS RETAINED. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 14627729 ↗

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