GENESIS II 71420538Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010208118), received between Feb 2, 2020 and Apr 21, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 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.

• InjuryApr 21, 2025Material Deformation; Loosening of Implant Not Related to Bone-Ingrowth; Material Deformation; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON 26-MAR-2025, TO REPLACE A DAMAGED AND LOOSE TIBIAL COMPONENT. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 21875747 ↗
• MalfunctionApr 5, 2022Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, IT WAS FOUND THAT A GENESIS II INSERT SIZE 5-6 11MM FAILED TO BE LOCKED AND FIXED WITH THE TIBIAL BASEPLATE. SURGERY WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A SMITH & NEPHEW BACK-UP INSERT. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14018423 ↗
• InjuryNov 24, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2021, THE GENESIS II CONSTRAINED ART INSERT SIZE 5-6 11MM ((B)(4)) BECAME LOOSE BECAUSE IT MAY NOT HAD BEEN LOCKED WHEN IMPLANTED, AND NEEDED TO BE REVISED ON 08-NOV-2021, ALONG WITH THE LEGION POSTERIOR STABILIZED NONPOROUS FEMORAL SIZE 4 LEFT ((B)(4)), THE GENESIS II NON-POROUS TIBIAL BASEPLATE SIZE 5 LEFT ((B)(4)) AND THE GEN II 7.5MM RESUR PAT 32MM ((B)(4)). CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12869343 ↗
• MalfunctionMar 10, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING TKA REVISION SURGERY THE SURGEON COULD NOT GET THE GENESIS II CON INS SIZE 5-6 11MM TO GO IN. THERE WAS NO HARM REPORTED. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE WITH NO SIGNIFICANT DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11457164 ↗
• InjuryFeb 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INFECTION. ANTIBIOTIC SPACERS WERE ALSO IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 9656960 ↗

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