GENESIS II 71420820Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010209597), received between Nov 14, 2017 and Oct 25, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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.

• MalfunctionOct 25, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT, DURING A TKA, THE CORRECT EXPOSURE OF THE TIBIA WAS PERFORMED IN ORDER TO PLACE THE GII PS INSERT SZ 3-4 13MM. THE POSITIONING OF THE INSERT WAS PERFORMED AND THEN WITH THE DEFINITIVE IMPACTOR TO PERFORM THE PROPER BLOCK IN THE DEFINITIVE TIBIA, IT WAS VISUALIZED THAT THERE IS A LIGHT BETWEEN THE INSERT AND THE TIBIA. THEN, IT WAS IMPACTED WITHOUT OBTAINING THE PROPER INSERTION. THIS PROCESS WAS PERFORMED THREE TIMES WITHOUT ANY SUCCESS. SURGERY WAS PERFORMED AFTER A DELAY GREATER THAN 30 MIN, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18008245 ↗
• InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER 13 YEARS FROM THE PRIMARY PROCEDURE, A REVISION SURGERY TO REPLACED A POLY WAS PERFORMED DUE TO A POST-BROKE IN THE PATIENT. THE GII PS INSERT SZ 3-4 13MM WAS EXPLANTED. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 11593552 ↗
• InjuryNov 14, 2017Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A SURGERY THE INSERT DID NOT LOCK INTO THE LEFT TIBIAL BASEPLATE. IT WAS FOUND THAT THE TRAILING EDGE OF THE INSERT AND THE JOINT OF TIBIAL BASEPLATE DID NOT MATCH. THE TOTAL DELAY OF THE SURGERY WAS 70 MINUTES AND ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 7028069 ↗

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