GENESIS II 71421511Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010492937), received between Mar 7, 2018 and Dec 6, 2024 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2024Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging

  IT WAS REPORTED THAT, DURING THE SET UP FOR A KNEE SURGERY, IT WAS NOTICED THAT THE OUTER PACKAGING ON ONE (1) GII PS HI FLEX ISRT SZ 3-4 15 WAS INTACT, AND THE INNER PACKAGING HAS BEEN OPENED. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860680 ↗
• InjuryJul 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED ON AN (B)(6) 2022, DURING WHICH A GENESIS II BASEPLATE, A LEGION PS FEMUR, AND A GII PS HI FLEX ISRT SZ 3-4 15 WERE PLACED, THE PATIENT EXPERIENCED POLY DISSOCIATION. THE SURGEON STATED THAT THE LOCKING MECHANISM OF THE GENESIS II BASEPLATE IS VERY ROBUST; HOWEVER, HE ENSURED DURING THE SURGERY THAT THE POLY WAS PROPERLY LOCKED IN. IT IS UNKNOWN HOW THIS ADVERSE EVENT WAS TREATED. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 19741491 ↗
• InjuryJan 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A SURGERY HAD BEEN PERFORMED ON (B)(6) 2010, PATIENT REPORTED DISCOMFORT. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON (B)(6) 2021 TO REPLACE THE GII PS HI FLEX ISRT SZ 3-4 15. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Discomfort

  MAUDE report 13159755 ↗
• InjuryNov 5, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO MEDIAL LAXITY/GAPPING. DURING THE REVISION SURGERY THE SURGEON SWAPPED THE 15 MM HIFELX INSERT FOR A 21 MM.

  Patient problems: Joint Disorder

  MAUDE report 10797203 ↗
• InjuryJan 14, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO POLY DISLOCATION. POLY WAS EXCHANGED AND REPLACED. PRIMARY SURGERY PERFORMED ON (B)(6) 2018.

  Patient problems: Injury

  MAUDE report 9586489 ↗
• InjuryDec 31, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE RIGHT TIBIAL BASEPLATE AND THE PS TIBIAL INSERT WERE REVISED DUE TO PAIN.

  Patient problems: Injury; Pain

  MAUDE report 8206209 ↗
• InjuryMar 7, 2018Material Fragmentation; Material Fragmentation

  IT WAS REPORTED A REVISION SURGERY FOR POLY REPLACEMENT SINCE PATIENT WAS LOOSE IN FLEXION. WHEN SURGEON OPENED THE KNEE, HE FOUND A PIECE OF CHIPPED POLY ON POSTERIOR SIDE.

  Patient problems: Failure of Implant; Limited Mobility Of The Implanted Joint

  MAUDE report 7320479 ↗

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-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-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-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
• 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-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