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GENESIS II 71422072Recalls & reported problems

Smith & Nephew, Inc. · GENESIS II HYDROXYAPATITE POROUS TIBIAL BASEPLATE SIZE 7 RIGHT · Class 2 · Implant

All models of GENESIS II (462)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010496386), received between Oct 15, 2021 and Jul 28, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (1 report).

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Loss of Osseointegration1
  • Migration1

Patient problems

  • Deformity/ Disfigurement1
  • Failure of Implant1
  • Inadequate Osseointegration1
  • Joint Laxity1
  • Osteolysis1
  • Unspecified Infection1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 28, 2022Loss of Osseointegration; Migration; Loss of Osseointegration; Migration

    BILATERAL PATIENT. IT WAS REPORTED THAT, AFTER AN INITIAL RIGHT TKA HAD BEEN PERFORMED ON (B)(6) 2012 DUE TO DEGENERATIVE JOINT DISEASE AND GENU VARUM MALALIGNMENT WITH MILD FLEXION CONTRACTURE OF THE RIGHT KNEE, THE PATIENT EXPERIENCED MECHANICAL LOOSENING OF THE JOINT. X-RAYS SHOWED THE TIBIAL COMPONENT HAD AN AUGMENT MEDIAL AND LATERAL AND AN EXTENDED STEM. PLAINTIFF UNDERWENT A RIGHT KNEE REVISION SURGERY ON (B)(6) 2019, WHERE A GROSS LOOSENING AND SUBSIDENCE OF TIBIAL COMPONENT INTO EXTREME VARUS WAS FOUND. THE PATELLA COMPONENT WAS RETAINED. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

    Patient problems: Deformity/ Disfigurement; Failure of Implant; Inadequate Osseointegration; Joint Laxity; Osteolysis

    MAUDE report 15123237 ↗
  • InjuryOct 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED RIGHT KNEE INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON AN UNKNOWN DATE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 12639659 ↗

Other PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices →

Sources and updates

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