GENESIS II 71420026Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010205568), received between Jun 12, 2018 and Aug 6, 2018 — classified as 3 injuries, 2 malfunctions.

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

• MalfunctionAug 6, 2018Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT BOX STATES 6 RIGHT, ACTUAL SIZE INSIDE BOX 4 LEFT.

  Patient problems: No Information

  MAUDE report 7753502 ↗
• InjuryJul 20, 2018Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT, AFTER OPENING THE PACKAGING MARKED AS FEMORAL COMPONENT SIZE 6 RIGHT SIDE IT WAS FOUND THAT THE FEMORAL COMPONENTS IS SIZE 4 AND THE LEFT SIDE NOT AS SHOWN IN THE PACKAGING AND LABELS. THE TIBIA ITSELF WAS CEMENTED, UNFORTUNATELY ANOTHER FEMORAL COMPONENT WAS NOT AVAILABLE IN THE SECOND LINE OF CONSIGNMENT (NO REPLENISHMENT), RE-SIZING AND RE-CUTTING OF POSTERIOR/ ANTERIOR/CHAMFERS WAS DONE AND THE SMALLER SIZE WAS IMPLANTED, (RIGHT "5") BUT A INDENTATION IN THE COCHLEA SHOULD BE NOTED WHICH MAY RESULT IN WEAKENING OF THE STRUCTURE FEMUR AND AFFECT THE INCREASED RISK OF FRACTURE OF FEMUR.

  Patient problems: Injury

  MAUDE report 7705810 ↗
• InjuryJul 18, 2018Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT, ON (B)(6) 2018, TOTAL KNEE REPLACEMENT PROCEDURE WAS PERFORMED WITH THE GENESIS II SYSTEM. DURING THE PROCEDURE, STANDARD CUTTING AND SIZING TECHNIQUES WERE USED. AT THE STAGE OF SIZING OF THE COMPONENTS FEMORAL COMPONENTS SIZE 6 RIGHT SIDE, RIGHT TIBIA SIZE 4 AND THE INSERT CR 3-4 9 MM WERE SELECTED. THE COMPONENT ASSEMBLY STAGE WAS COMPLETED WITH THE SELECTION OF THE CORRECT COMPONENTS AND CONFIRMATION OF THEIR PARAMETERS BY THE SCRUB NURSE AND THE MAIN OPERATOR. AFTER OPENING THE PACKAGING MARKED REF: 71420026 AND BATCH NO 16CMB0066A, CEMENTATION IMPLANTS WERE PREPARED. AT THE COMPONENTS CEMENTING STAGE, IT WAS FOUND THAT THE FEMORAL COMPONENTS IS SIZE 4 AND THE LEFT SIDE (REF 71420006 BATCH 14CM08606) NOT AS SHOWN IN THE PACKAGING AND LABELS. THE TIBIA ITSELF WAS CEMENTED BUT FEMORAL COMPONENTS HAD TO BE OPENED WITH THE NEW RIGHT ONE IN WHICH THE IMPLANT WAS PROPERLY PACKED.

  Patient problems: Injury

  MAUDE report 7697381 ↗
• MalfunctionJul 10, 2018Patient-Device Incompatibility

  IT WAS REPORTED THAT DURING PROCEDURE, SURGEON ASKED FOR A RIGHT SIZE 6 IMPLANT. THE CORRECT IMPLANT BOX WAS OPENED AND INSIDE WAS A LEFT SIZE 4 IMPLANT.

  Patient problems: No Information

  MAUDE report 7674651 ↗
• InjuryJun 12, 2018Packaging Problem; Packaging Problem

  AT THE MOMENT OF OPENING THE IMPLANTS, INSIDE THE FEMUR BOX, WHICH HAD A DESCRIPTION OF SIZE 6 R, C-R, OF CHROMIUM COBALT GENESIS II, WE FOUND AN IMPLANT OF SIZE 4 LEFT C-R OF CHROMIUM COBALT GENESIS II, EVEN WITH A 6R C-R STICKER. AFTER THE FRUSTRATION OF THE SURGEON AND THE INCOMPREHENSION OF THE MEDICAL TEAM, AND NOT HAVING HOW TO SOLVE THE PROBLEM QUICKLY DUE TO THE DISTANCE WITH THE WAREHOUSE AND THE ANESTHETIZED PATIENT, IT WAS DECIDED TO OPEN OTHER FEMUR IMPLANT SIZE 5 R, CHROMIUM COBALT GENESIS II, AND AFTER, IT WAS PHYSICALLY CHECKED DUE TO THE PREVIOUS ISSUE. THE FEMUR WAS WORKED WITH BLOCKS OF SIZE 5, AND FINALLY IT WAS PLACED AN IMPLANT 5 R, CR, CRCO GENESIS II, MODIFYING THE SIZE OF THE PATIENT'S FEMUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7590262 ↗

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