GENESIS II 71420502Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010207951), received between May 5, 2021 and Jan 21, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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.

• MalfunctionJan 21, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING A TKA SURGERY THE TYVEK WRAP HAD SEPARATED; LEAVING ONE (1) GII C/R ART INS SZ5-6 11MM UNSTERILE. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACK-UP DEVICE. IT IS UNKNOWN IF THIS ISSUE CAUSED ANY DELAY; HOWEVER, NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24130722 ↗
• InjuryFeb 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2008, THE PATIENT EXPERIENCED JOINT INSTABILITY. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6)2022 TO EXCHANGE THE GII C/R ART INS SZ5-6 11MM. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF THE PATIENT.

  Patient problems: Joint Laxity

  MAUDE report 13407658 ↗
• InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A GENESIS II SYSTEM HAD BEEN IMPLANTED 20 YEARS AGO, THE PATIENT NOW IS EXPERIENCING JOINT LAXITY. A REVISION SURGERY WAS BOOKED TO EXPLANT THE GII C/R ARTICULAR INSERT SZ5-6 11MM. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 11777520 ↗

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