GENESIS II 71420122Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010206053), received between Jan 28, 2019 and Dec 10, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.

• InjuryDec 10, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SYSTEM HAD BEEN IMPLANTED ON (B)(6) 2015 WITH A GENESIS II SYSTEM, THE PATIENT STARTED EXPERIENCING SYMPTOMS IN THE MIDDLE OF 2016, WHICH INCREASED OVER TIME. ON (B)(6) 2020, LOOSENING OF FEMORAL AND TIBIAL COMPONENTS WAS DIAGNOSED VIA X-RAYS. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2020 TO CONVERT FROM THE PS GENESIS II CONSTRUCT TO A LEGION HK SYSTEM. PATIENT WAS DISCHARGED WITH REHAB.

  Patient problems: Deformity/ Disfigurement; Inadequate Osseointegration

  MAUDE report 18298545 ↗
• InjuryJun 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A MULTI FRAGMENTARY PERIPROSTHETIC FRACTURE OF THE RIGHT DISTAL FEMUR, THE PATIENT UNDERWENT A SURGERY ON (B)(6) 2022, IN WHICH A REDUCTION AND AN OSTEOSYNTHESIS WITH A PLATE (COMPETITOR'S DEVICE), SCREWS (COMPETITOR'S DEVICE) AND WAD WITH BONE GRAFTS WERE PERFORMED. AFTER THIS INTERVENTION, THE PATIENT PRESENTED LOSS OF FRACTURE REDUCTION, DEHISCENCE OF THE SURGICAL WOUND, LOOSENING OF ONE SCREW, PARTIAL LOOSENING OF TWO OTHER SCREWS AND SIGNS OF LOCAL SEPTIC INFLAMMATION. THEREFORE, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022 FOR THE REMOVAL OF SYNTHESIS AND KNEE PROSTHESIS INCLUDING THE GII NONPOROUS PS FEM SZ 6 RT, THE GII PS HI FLEX ISRT SZ 5 6 9 AND THE GNS II CMT TIB SIZE 5 RIGHT, IN ORDER TO PERFORM A RESECTION OF THE DISTAL FEMUR AND KNEE ARTHRODESIS WITH CEMENTED ARTHRODESIZING NAIL. THE PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Inflammation

  MAUDE report 14638378 ↗
• InjuryJan 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY OF SMITH AND NEPHEW DEVICES WAS PERFORMED DUE TO A CHRONIC UNTREATABLE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8283180 ↗

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-0131-2014 · Oct 7, 2013 · Terminated
  GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic
• Z-0130-2014 · Oct 7, 2013 · Terminated
  GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic