GENESIS II 71420512Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010208002), received between Jan 10, 2019 and Jan 10, 2019 — classified as 1 malfunction.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING SURGERY THE SURGEON WAS READY TO IMPLANT THE FINAL PROSTHESES BUT THEN REALISED THE POLY INSERT IMPLANTS WERE NOT PRESENT WITH THE LOAN KID. THE PATIENT WAS KEPT UNDER GENERAL ANAESTHETIC WHILE THE REQUIRED POLY INSERT WAS BROUGHT URGENTLY FROM SOUTHMEAD HOSPITAL, WHICH HAS CONSIGNMENT STOCK. THE PROCEDURE WAS COMPLETED ONCE THE IMPLANT ARRIVED, APPROXIMATELY 1 HOUR AFTER THE ERROR WAS DISCOVERED. NO HARM TO PATIENT WAS REPORTED. BACKUP DEVICE WAS AVAILABLE BUT IN OTHER HOSPITAL. 1 HOUR DELAY DUE TO THE DISTANCE BETWEEN HOSPITALS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8237642 ↗

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