GENESIS II 71421512Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010492944), received between Nov 24, 2017 and Dec 21, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K032295); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED SOME TIME AGO, THE PATIENT PRESENTED UNSTABILITY, POSSIBLE TO VMO (VASTUS MEDIALIS OBLIQUE) TEAR. A REVISION SURGERY WAS PERFORMED SO THE 3-4 18MM GII PS HI FLEX INSERT WAS TAKEN OUT AND REPLACED WITH A 3-4 25MM GENESIS LL CONSTRAINED INSERT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11052171 ↗
• InjuryJul 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED INFECTION IN KNEE, BLOOD CLOTS AND ENDED UP IN ICU WITH FEVER. ASPIRATION OF KNEE DID NOT SHOW INFECTION, HOWEVER CONTINUED TO BE FEBRILE. ORTHOPEDIC TEAM DECIDED TO UNDERGO COMPREHENSIVE WASHOUT AND POLY EXCHANGE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 10299185 ↗
• InjuryMar 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY HAS BEEN PERFORMED. LEFT FEMORAL COMPONENT WAS EXPLANTED.

  Patient problems: Injury

  MAUDE report 8434476 ↗
• InjuryNov 24, 2017Migration or Expulsion of Device; Failure to Osseointegrate; Migration or Expulsion of Device; Failure to Osseointegrate

  IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION OF LEFT LEGION REVISION DUE TO PAIN, WHICH RESULTED FROM TIBIAL TRAY INTERNALLY ROTATION.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7057634 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032295. One submission often covers many models, so check the product and lot details in each record.

• Z-0447-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), REF 71421515, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0448-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0449-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), REF 71621509, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0445-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), REF 71420820, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0444-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1), REF 71420806, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0446-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic