GENESIS II 71420124Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010206060), received between Apr 25, 2018 and Oct 1, 2020 — classified as 4 injuries, 1 malfunction.

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

• InjuryOct 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS SCHEDULED FOR A PATELLA AND AN INSERT EXCHANGE, HOWEVER DURING PROCEDURE THE FEMORAL IMPLANT CAME OFF BY HAND. PROCEDURE WAS CONCLUDED BY REMOVING ALL COMPONENTS AND INSERTING A CEMENT SPACER AS PART OF A 2 STAGE REVISION.

  Patient problems: Injury

  MAUDE report 10617455 ↗
• MalfunctionJul 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING PROCEDURE, THERE WAS A DENT IN THE SIDE OF THE FEMUR. IT WAS NOT POSSIBLE TO FIX THE IMPLANT IMPACTOR DUE TO THE DENT. BECAUSE OF LOW STOCK (BACK ORDERS) IT WAS NOT POSSIBLE TO RETURN THE IMPLANT. THE SURGEON IMPLANTED THE DEVICE FREE HAND. NO INJURIES REPORTED. A DELAY NO LONGER THAN 30 MIN WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8787550 ↗
• InjuryJun 3, 2019Fracture; Fracture

  IT WAS REPORTED THAT PATIENT HAS A TIBIAL FRACTURE AND AN INFECTION WAS ALSO CONFIRMED. THEREFORE A REVISION SURGERY WAS PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 8663101 ↗
• InjuryJun 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER EVALUATION, THE PATIENT WAS REFERRED TO A JOINT NEEDLE ASPIRATION DEPARTMENT, WHICH CONFIRMED THE SEPTIC STATE AND LED TO THE ISOLATION OF THE SAME BACTERIAL STRAIN. ON (B)(6) 2018 THE PATIENT WAS THEREFORE SUBJECTED TO COMPLETE PROSTHETIC REMOVAL SURGERY AND REPLACEMENT WITH AN ANTIBIOTIC CEMENT SPACER - SURGICAL PROCEDURE - DURATION 1 HOUR AND 48 MINUTES.

  Patient problems: Unspecified Infection

  MAUDE report 7644667 ↗
• InjuryApr 25, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED AND THE DOCTOR NOTICED THAT THE IMPLANTS BEING REMOVED WERE NOT ADHERING TO THE ADHESIVE ON THE TIBIAL BASE. CEMENT ADHESION WAS PRESENT ON THE FEMORAL COMPONENTS BUT NOT ON THE TIBIAL.

  Patient problems: Injury

  MAUDE report 7462732 ↗

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