GENESIS II 71420838Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010209689), received between Sep 2, 2020 and Oct 1, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• InjuryOct 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A BROKEN POST OF ONE (1) GII PS INSERT SZ 5-6 18MM. THIS ADVERSE EVENT WAS SOLVED BY TKA REVISION SURGERY ON (B)(6) 2024, IN WHICH THE INSERT WAS EXCHANGED FOR AN 18 MM PS CONSTRAINED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 20345164 ↗
• InjuryJul 9, 2021Break; Break

  IT WAS REPORTED THAT, AFTER TOTAL KNEE REPLACEMENT SURGERY HAD BEEN PERFORMED ON 2009, THE PATIENT EXPERIENCED KNEE PAIN AND SOME INSTABILITY. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2021. IT WAS OBSERVED THAT THE GENESIS II POSTERIOR STABILIZED INSERT SIZE 5-6 18MM WAS BROKEN, FOR WHICH IT WAS CHANGED AND PATELLA WAS PLACED. PATIENT IS CURRENTLY HEALTHY.

  Patient problems: Arthralgia; Joint Laxity

  MAUDE report 12144737 ↗
• MalfunctionSep 2, 2020Unstable; Defective Device; Unstable; Defective Device

  IT WAS REPORTED THAT DURING TKA PROCEDURE, AFTER TIBIA AND FEMUR IMPLANTATION, THE GII PS INSERT SZ 5-6 18MM WAS ATTEMPTED TO BE INSERTED. IT WAS PUT IN THE TIBIAL COMPONENT AND WASN'T STILL LOCKED. THE LINER WAS UNSTABLE. NO DELAY. A S&N BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO INJURIES REPORTED AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10482167 ↗

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