GENESIS II 71420528Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010208064), received between Jun 12, 2018 and Mar 31, 2023 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (2 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2023, THE GNS II CON INS SZ 3-4 15MM HAD TO BE REMOVED ON (B)(6) 2023 DUE TO INFECTION. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 16656201 ↗
• MalfunctionMar 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED WITH A GENESIS II SYSTEM, THE PATIENT SUFFERED A RUPTURED OF THE MEDIAL LATERAL LIGAMENT AND WAS UNSTABLE; THEREFORE A REVISION SURGERY WAS PERFORMED AND THE 15MM POLY WAS REPLACED BY A 21MM POLY. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Damage to Ligament(s); Joint Laxity

  MAUDE report 11547472 ↗
• MalfunctionJan 17, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, THE LATERAL SIDE OF THE 15MM INSERT COULDN¿T SIT PROPERLY INTO THE TIBIA PLATE AFTER SEVERAL ATTEMPTS. HOWEVER, WE HAD ONLY ONE PIECE OF SUCH INSERT IN THE IMPLANT BOX. HENCE, DOCTOR USED 13MM INSERT INSTEAD. NO INJURY OR PATIENT HARM REPORTED. DELAY OF 15 MINUTES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9601538 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9565521 ↗
• InjuryDec 9, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019, DUE TO INFECTION. WASHOUT PERFORMED, EXCHANGE OF INSERT FOR ONE OF THE SAME SIZE.

  Patient problems: Unspecified Infection

  MAUDE report 9440583 ↗
• InjuryJun 13, 2018Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A POLY EXCHANGE/WASHOUT YESTERDAY, DOCTOR WAS UNABLE TO GET BOTH SIZE 3-4 15MM CONSTRAINED INSERTS TO LOCK INTO THE REVISION BASEPLATE. ONE SEEMED TO BE DAMAGED WHILE IMPACTING. SURGERY WAS DELAYED MORE THAN 2 HOURS.

  Patient problems: Injury

  MAUDE report 7597616 ↗
• InjuryJun 12, 2018Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A POLY EXCHANGE/WASHOUT YESTERDAY, DOCTOR WAS UNABLE TO GET BOTH SIZE 3-4 15 MM CONSTRAINED INSERTS TO LOCK INTO THE REVISION BASEPLATE. ONE SEEMED TO BE DAMAGED WHILE IMPACTING. SURGERY WAS DELAYED MORE THAN 2 HOURS.

  Patient problems: Injury

  MAUDE report 7590249 ↗

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