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GENESIS 726203Recalls & reported problems

Smith & Nephew, Inc. · GENISIS UNI LEFT MEDIAL/RIGHT LATERAL LARGE TIBIA BASE · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010256904), received between Jan 3, 2019 and Jan 3, 2019 — classified as 1 injury.

2 other recalls cover devices cleared under the same FDA submission (K912735); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Injury1

Recent adverse event reports

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

  • InjuryJan 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO UNSPECIFIED REASONS. IT WAS REPORTED THAT WHEN ATTACHING THE CHISEL BLADE TO REMOVE A SINGLE-CONDYLAR PROSTHESIS G-II FROM 1ST IMPLANTATION ON (B)(6) 2015, THE FEMORAL COMPONENT IMMEDIATELY BECOMES TORN AND BREAKS OFF DIRECTLY AT THE PROXIMAL SHIELD. SURGEON STATES THAT THERE WERE A DISTINCTIVE PE WEAR DUE TO THE VARICOSE JOINT AXIS OF AN IMPLANTED MEDIAL G-II SINGLE-CONDYLAR PROSTHESIS. THE LATERAL FEMORAL CONDYLE ALSO SHOWED CONSIDERABLE CYSTIC DEFECTS DUE TO METAL AND PE ABRASION - SO THAT AFTER EXPLANTATION OF THE MEDIAL SLIDE A LEGION REVISION PROSTHESIS WITH BAR EXTENSION TIBIALLY AND FEMORALLY, POSTIOR LAT. WEDGE 5 MM FEMORAL AND MEDIAL TIBIAL WEDGE 5 MM AND CC INLAY 11 MM WERE IMPLANTED. ALSO, WAS REPORTED THAT THE FEMORAL AND TIBIAL COMPONENTS THEMSELVES WERE WELL CEMENTED AND NOT LOOSENED.

    Patient problems: Injury

    MAUDE report 8212349 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K912735. One submission often covers many models, so check the product and lot details in each record.

  • Z-0305-05 · Jun 21, 2004 · Terminated
    Tibial Base Plates
  • Z-0304-05 · Jun 21, 2004 · Terminated
    Genesis Uni Articular Inserts

Other PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices

All PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.