GENESIS II 71420492Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010207906), received between Jul 3, 2019 and Jul 21, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT, DURING A TKA SURGERY SETUP, A GENESIS II CRUCIATE/RETAINING ARTICULAR INSERT SIZE 3-4 11M STERILE PACKAGING WAS NOTICED TO BE COMPROMISED. THE INNER BAG WAS NOT SEALED AND THE INSERT WAS OUTSIDE OF THE BAG, THOUGH IN THE BOX. SURGERY WAS COMPLETED WITH A BACKUP DEVICE INSTEAD, WITHOUT ANY DELAY. PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12201272 ↗
• InjuryJul 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A REVISION SURGERY PERFORMED DUE TO DISLOCATION OF THE INSERT. X-RAYS SHOWED THE INSERT WAS FULLY DISLOCATED FROM THE JOINT AND SITTING FLAT AGAINST THE ANTERIOR PROXIMAL TIBIA WHICH WAS CAUSING PAIN TO THE PATIENT. AS PER INFORMATION PROVIDED, PATIENT HAD FALLEN DOWNSTAIRS WHEN DISLOCATION OCCURRED. PATIENT WAS REPORTED TO HAVE FULL MOBILITY AFTER SURGERY.

  Patient problems: Joint Dislocation

  MAUDE report 8756534 ↗

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