GENESIS II 71421525Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010493002), received between May 31, 2022 and Feb 18, 2026 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA THAT HAD BEEN PERFORMED ON UNKNOWN DATE, THE PATIENT WAS GETTING UP FROM THEIR CHAIR AND FELT A POP. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY IN WHICH THE GII PS HI FLEX ISRT SZ 7-8 15 WAS EXCHANGED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Discomfort; Fall; Insufficient Information

  MAUDE report 24383784 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A GENESIS II PS TKA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT'S KNEE, THE PATIENT REQUIRED A REVISION SURGERY DUE TO UNSPECIFIED REASONS/SYMPTOMS. DURING THIS PROCEDURE, THE GII PS HI FLEX ISRT SZ 7-8 15 WAS EXPLANTED. THE IDENTITY OF THE PROSTHESIS IMPLANTED IN EXCHANGE IS UNKNOWN AT THIS TIME. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 14570898 ↗
• InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A GENESIS II PS TKA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT'S KNEE, THE PATIENT REQUIRED A REVISION SURGERY DUE TO UNSPECIFIED REASONS/SYMPTOMS. DURING THIS PROCEDURE, THE GII PS HI FLEX ISRT SZ 7-8 15 WAS EXPLANTED. THE IDENTITY OF THE PROSTHESIS IMPLANTED IN EXCHANGE IS UNKNOWN AT THIS TIME. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 14555949 ↗

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-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
• 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-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