GENESIS II 71420834Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010209665), received between Aug 7, 2020 and Jun 11, 2025 — classified as 5 injuries.

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

• InjuryJun 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED IN 2005, THE PATIENT EXPERIENCED KNEE PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025, IN WHICH IT WAS FOUND THAT THE GII PS INSERT SZ 5-6 13MM HAD A BROKEN POST. THE INSERT WAS REPLACED WITH A LGN XLPE PS INSERT SZ 5-6 13MM. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 22185482 ↗
• InjuryJan 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED IN 2008, THE PATIENT HAD PAIN AT PATELLA AND THE PATELLA BUTTON WAS REMOVED. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, IN WHICH IT WAS FOUND THAT THE GII PS INSERT SZ 5-6 13MM HAD THE PS POST BROKEN. THE POST AND POLY WERE REMOVED AND REPLACED WITH A 5-6 15MM INSERT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 21060197 ↗
• InjuryNov 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2010, THE PATIENT EXPERIENCED A BROKEN POSTERIOR STABILIZED POST. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2024 IN WHICH THE GII PS INSERT SZ 5-6 13MM WAS EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 20757144 ↗
• InjuryJan 8, 2021Break; Break

  IT WAS REPORTED THAT 10 YEARS AFTER PRIMARY TKR, PATIENT PRESENTED A CLUNK. A REVISION SURGERY WAS PERFORMED TO INVESTIGATE THE CLUNK, IT WAS FOUND THAT THE POST OF THE POLY HAD SNAPPED OFF COMPLETELY. DEVICE WAS EXPLANTED AND THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 11141667 ↗
• InjuryAug 7, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GENESIS II PS INSERT SIZE 5-6 13MM COULD NOT BE IMPLANTED. THE PROCEDURE WAS FINISHED WITH A CHANGE IN SURGICAL TECHNIQUE BY USING A DIFFERENT THICKNESS INSERT: AN 11MM WAS USED INSTEAD OF THE 13MM ONE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10379640 ↗

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