GENESIS II 71420846Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010209726), received between Oct 2, 2020 and Jul 24, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Fracture” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON UNKNOWN DATE, THE PATIENT EXPERIENCED A FRACTURED OF THE INSERT. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH A GII PS INSERT SZ 7-8 11MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22602393 ↗
• InjuryApr 24, 2024Fracture; Fracture

  IT WAS REPORTED THAT AFTER A TKA HAD BEEN PERFORMED IN 2007, PATIENT EXPERIENCED PS INSERT POST BREAKAGE. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE GII PS INSERT SZ 7-8 11MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 19176914 ↗
• InjuryApr 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER SURGERY HAD BEEN PERFORMED ONE (1) GII PS INSERT SZ 7-8 11MM HAD A BROKEN POST. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2024. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 19053171 ↗
• InjuryApr 25, 2022Break; Break

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2011, THE PATIENT EXPERIENCED INSTABILITY IN THEIR KNEE. IN ADDITION, SURGEON DISCOVERED THAT POST HAD BROKEN. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2011 TO EXCHANGE THE GII PS INSERT SZ 7-8 11MM. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 14192190 ↗
• InjuryNov 30, 2021Break; Break

  IT WAS REPORTED THAT, AFTER TKR SURGERY HAD BEEN PERFORMED ON (B)(6) 2007, THE PATIENT EXPERIENCED INSTABILITY IN THE KNEE. IT WAS FOUND THAT THE DEVICE SNAPPED OFF. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 12899347 ↗
• InjuryOct 2, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, ELEVEN YEARS AFTER A KNEE ARTHROPLASTY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED INSTABILITY. A REVISION SURGERY WAS PERFORMED TO ADDRESS THE ISSUE: THE GENESIS II PS INSERT POST WAS FOUND TO BE WORN. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 10623294 ↗

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