GENESIS II 71420572Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010208286), received between May 5, 2018 and Sep 5, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2023Migration; Migration

  IT WAS REPORTED THAT, AFTER A TKA THAT TOOK PLACE ON (B)(6) 2008. A REVISION SURGERY HAD TO BE PERFORMED ON (B)(6) 2023 DUE TO THE GNS II BICONVEX PAT 32MM BECOMING DISLODGED, RESULTING IN IT FREELY MOVING IN THE KNEE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 17687700 ↗
• InjuryOct 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  US LEGAL. IT WAS REPORTED THAT, AFTER AN TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2008, THE POST OF A GII PS HI FLEX ISRT SZ 5-6 11 BROKE, MAKING THE KNEE UNSTABLE. ON (B)(6) 2020, AN ARTHROSCOPY WAS PERFORMED TO CONFIRM POST BREAKAGE. THE INSERT WAS EXCHANGED DURING A REVISION SURGERY ON (B)(6) 2020. DURING SURGERY, THE PATELLA SHOWED MINIMAL WEAR AND A PATELLAR TIBIAL TUBERCULE PIN WAS PLACED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS THEN TRANSPORTED TO THE RECOVERY ROOM IN GOOD CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 12602211 ↗
• InjuryJul 24, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATELLA WAS REVISED DUE TO LOOSENING AND POSSIBLE VASCULAR NECROSIS OF THE NATIVE PATELLA. DR. STATED THAT THE PEGS ON THE ORIGINAL 35 MM RESURFACING GEN II PATELLA REF 71420578 WERE NOT IN THE SAME PLACE AS THE CEMENT PLUGS, SO THE COMPONENT SEEMS TO HAVE MOVED INSIDE THE BONE. THE PATELLA WAS REMOVED AND REPLACED WITH A 32 MM BICONVEX PATELLA (PICTURED). NO OTHER COMPONENTS WERE TOUCHED. NO MORE INFORMATION PROVIDED YET.

  Patient problems: Injury

  MAUDE report 8821442 ↗
• InjuryJul 22, 2019Unstable; Unstable

  IT WAS REPORTED THAT A SECOND STAGE REVISION WAS PERFORMED DUE TO INFECTION AND LOOSENING.

  Patient problems: Unspecified Infection

  MAUDE report 8813871 ↗
• InjuryMay 5, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT PRESENTED 4 YEARS POST TKR WITH PATELLA IMPLANT BROKEN OFF AND LODGED BEHIND FEMORAL PROSTHESIS BETWEEN POSTERIOR CONDYLES. REVISION SURGERY REQUIRED TO REMOVE BROKEN/LOOSE PATELLA, AND TIBIAL INSERT MAY NEED TO BE REMOVED (EXCHANGED) TO FACILITATE REMOVAL.

  Patient problems: Joint Dislocation

  MAUDE report 7489385 ↗

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