GENESIS II 71420768Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010209337), received between Jul 27, 2017 and Apr 27, 2023 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Degraded” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2023Positioning Failure; Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16825712 ↗
• MalfunctionMay 21, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING A TKA, THE STERILIZED PACKING OF A GENESIS II DISHED ARTICULAR INSERT SIZE 3-4 11MM WAS FOUND OPEN. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACKUP DEVICE. THE PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14466795 ↗
• InjuryApr 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKR HAD BEEN PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED ANTERIOR KNEE PAIN AND SLIGHT LIGAMENT LAXITY. A REVISION SURGERY WAS PERFORMED TO ADDRESS THE ADVERSE EVENT; A PATELLA RESURFACING AND POLY EXCHANGE WAS MADE. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11644144 ↗
• InjuryMar 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A REGISTER REPORT FROM EPRD (ENDOPROTHESENREGISTER DEUTSCHLAND) THAT THERE WERE SIX REVISION SURGERIES 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478946 ↗
• InjurySep 16, 2020Degraded; Naturally Worn; Degraded; Naturally Worn

  IT WAS REPORTED THAT, 16 YEARS AFTER A TKA SURGERY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED PAIN IN THE KNEE POSTERIOR SECTION. ON REVISION SURGERY, IT WAS NOTICED THAT THERE WAS MINIMAL WEAR ON THE INSERT, MOSTLY POSTERIOR, WHICH CAUSED PAIN, SO THE SURGEON DECIDED TO EXCHANGE IT SINCE EVERYTHING ELSE WAS VERY WELL IN PLACE AND STABLE. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant; Injury; Pain

  MAUDE report 10540892 ↗
• InjuryJul 27, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT KNEE REVISION WAS PERFORMED DUE TO INFECTIONS. KNEE WAS ASPIRATED AND CULTURES GROWN. KNEE JOIN EXPOSED DEBRIDED SPECIMENS TAKEN ANE WASHED OUT WITH 8 LITERS OF SALINE. POLY REMOVED AND NEW POLY REPLACED. THE DOCTOR DOESN'T FAULT THE PRODUCT.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 6747778 ↗

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