GENESIS II 71420770Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010209344), received between Apr 25, 2019 and Apr 28, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER LEFT TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED A LATERAL RELEASE. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2026, IN WHICH THE GII DISHED INS SZ 3-4 13MM WAS EXCHANGE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 25024094 ↗
• MalfunctionJul 13, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, THE GII DISHED INS SZ 3-4 13MM COULD NOT LOCKED INTO BASEPLATE. A 15 MM INSERT WAS USED INSTEAD WITHOUT PROBLEM. SURGERY WAS RESUMED, WITH A GREATER THAN 30 MINUTES DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15008921 ↗
• InjuryMar 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A REGISTER REPORT FROM ((B)(4)) THAT THERE WAS ONE REVISION SURGERY PERFORMED TO REPLACE THE INSERT IMPLANT GENESIS II DISHED INS SIZE 3-4 11MM. THERE IS NO ADDITIONAL INFORMATION ABOUT THE HOSPITAL, PATIENT AND SURGERY DATA. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Insufficient Information

  MAUDE report 11479177 ↗
• InjuryOct 7, 2020Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS CONDUCTED TO REPLACE A BROKEN INSERT, ALL BROKEN PARTS WERE EXTRACTED, THE PATIENT OUTCOME IS UNKNOWN. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10644906 ↗
• InjuryApr 25, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DR. WAS PERFORMING A PRIMARY TKR YESTERDAY, (B)(6), WHEN ATTEMPTING TO IMPLANT THE TIBIAL INSERT REALIZED THAT THERE WAS A DEFECT AT THE ANTERIOR LIP SUPERIORLY. THIS LOOKS LIKE A GAUGE INTO THE POLY, DEPICTED IN THE FOURTH IMAGE. HE SUBSEQUENTLY REQUESTED AND IMPLANTED ANOTHER INSERT. NO INJURIES OR DELAYS REPORTED. NO MORE INFORMATION AVAILABLE.

  Patient problems: Injury

  MAUDE report 8552928 ↗

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