GENESIS II 71421518Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010492968), received between Sep 30, 2020 and Nov 26, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2024Break; Break

  IT WAS REPORTED THAT, AFTER A TKA PERFORMED ON 2009, THE POST OF ONE (1) GII PS HI FLEX ISRT SZ 5-6 15 BROKE. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2024 IN WHICH THE GII PS HI FLEX ISRT SZ 5-6 15 WAS EXPLANTED, AND A 8 MM PS INSERT WAS IMPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 20778277 ↗
• InjuryMar 29, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A LEFT TKA HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A BROKEN POST OF THE GII PS HI FLEX ISRT SZ 5-6 15. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO ADDRESS THIS ADVERSE EVENT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 19007939 ↗
• InjuryApr 12, 2021Break; Break

  IT WAS REPORTED THAT, A (B)(6) YEAR OLD MALE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROSCOPY AND A LEFT TOTAL KNEE ARTHROSCOPY (RTKA/LTKA) POLY EXCHANGE. FEMORAL IMPLANT SIZE 7 ON A TIBAL BASEPLATE SIZE 6 (7/6/15/35) WAS POSSIBLE BROKEN POST AFTER A FALL. A REVISION SURGERY HAD TO BE PERFORMED ON (B)(6) 2021 AS GENESIS II PS HI FLEX INSERT SIZE 5-6 15 BROKE. AS PER REPORT, PATIENT TWISTED WRONG AND FELT UNSTABLE, AND UPON A REVIEW OF X-RAYS, IT WAS NOTICED THAT THE DEVICE POST BROKE OFF. THERE WERE NO IMPLANT RECORDS OF EXACT DATE OF ORIGINAL SURGERY, THE RESIDENT JUST KNEW THAT IT WAS IN 2008. IT IS UNCLEAR WHICH TIBIAL INSERT WAS EXCHANGED OR IF BOTH WERE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 11648440 ↗
• InjurySep 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO EXCHANGE GENESIS II PS HI FLEX INSERT SIZE 5-6 18. THE REASON FOR THE REVISION SURGERY IS UNKNOWN.

  Patient problems: Injury; No Information

  MAUDE report 10604405 ↗

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-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
• 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-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-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