GENESIS II 71420174Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 03596010206305), received between Jun 27, 2017 and Nov 13, 2023 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2014, THE PATIENT EXPERIENCED TIBIAL LOOSENING ISSUES WITH THE BONE CEMENT BONE INTEGRATION. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2023, IN WHICH THE GNS II CMT TIB SIZE 8 {} LT AND THE LGN PS HIGH FLEX XLPE SZ 7-8 11MM WERE EXPLANTED, FEMUR AND PATELLA COMPONENTS WERE LEFT INSIDE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18119918 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED PAIN APPROXIMATELY 6 MONTHS AFTER TOTAL KNEE REPLACEMENT. THIS ADVERSE EVENT WAS SOLVED BY TKA REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12919876 ↗
• MalfunctionMay 20, 2020Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A TOTAL KNEE REVISION SURGERY WAS PERFORMED BECAUSE THE POLY AND PATELLA IMPLANT FAILED FROM A PREVIOUS TOTAL KNEE SURGERY. MEDWATCH USER REPORT MW5093972.

  Patient problems: Injury

  MAUDE report 10077408 ↗
• InjuryDec 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT POLYETHYLENE INSERT WAS REMOVED AND AN ANTIBIOTIC SPACER WAS IMPLANTED DUE TO INFECTION THAT WAS CAUSING PAIN WITH SWELLING AND INABILITY TO WALK. ALSO, IRRIGATION AND DEBRIDEMENT WERE DONE IN THE SAME SURGERY.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8161463 ↗
• MalfunctionDec 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A MEDIAL INTERVENTION WAS PERFORMED. COMPLETE BILATERAL LOWER EXTREMITY ULTRASOUND EXAMINATION DUE TO PAIN AND EDEMA WAS PERFORMED. NO EVIDENCE OF CHRONIC OR DEEP VENOUS THROMBOSIS.

  Patient problems: Aspiration/Inhalation

  MAUDE report 8146793 ↗
• InjuryDec 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A MEDICAL INTERVENTION WAS PERFORMED, LEFT KNEE IRRIGATION AND DEBRIDEMENT WITH HEMATOMA EVACUATION WERE PERFORMED DUE TO CONTINUE IRRIGATION.

  Patient problems: Aspiration/Inhalation

  MAUDE report 8146295 ↗
• InjuryDec 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED IN THE PATIENT DUE TO PAIN AND SWELLING. NO DELAY REPORTED. IMPLANTS REPLACED WITH COMPETITOR DEVICES.

  Patient problems: Injury

  MAUDE report 8138192 ↗
• InjuryOct 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED ACUTE SEPSIS ON THE KNEE. REVISION SURGERY WAS PERFORMED TO REMOVE FEMORAL, TIBIAL AND PATELLAR COMPONENTS AS WELL AS ASSOCIATED CEMENT. ANTIBIOTIC BEADS WERE IMPLANTED.

  Patient problems: Injury; Sepsis

  MAUDE report 7921494 ↗
• InjurySep 25, 2018Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING THE TKR PROCEDURE THE FIRST LAYER OF THE STERILE PACKAGING HAS A CHIP OUT OF THE SIDE. THERE WAS NO SIGN OF THE CHIP IN THE PACKAGING. THE SURGEON CAREFULLY EXAMINED THE SECOND LAYER OF STERILE PACKAGING AND FOUND IT TO BE INTACT. HE PROCEEDED TO USE THE ITEM. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Information

  MAUDE report 7908172 ↗
• InjuryJun 7, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PATIENT HAD A LEGION/GENESIS KNEE IMPLANT ON (B)(6) 2015 AND UNDERWENT A REVISION SURGERY ON (B)(6) 2017 DUE TO INSTABILITY AND LEFT KNEE GIVING AWAY, PAIN, SWELLING, ACCOMPANIED BY WARMTH, ERYTHEMA AND FEVERS.

  Patient problems: Injury

  MAUDE report 7576902 ↗
• InjuryJan 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION SURGERY DUE TO ON GOING PAIN, SURGEON SUGGESTED TIBIA APPEARED INTERNALLY ROTATED. NO SIGNS OF INFECTION.

  Patient problems: Pain

  MAUDE report 7224072 ↗
• InjuryJun 27, 2017Unstable; Unstable

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED TO REMOVE THE TIBIAL BASEPLATE DUE TO LOOSENING AND TO RESURFACE THE PATELLA DUE TO KNEE PAIN.

  Patient problems: Pain

  MAUDE report 6669950 ↗

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