GENESIS II 71421116Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010469304), received between Sep 16, 2019 and Nov 22, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 other recall cover devices cleared under the same FDA submission (K022010, K962557); 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 16, 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.

• InjuryNov 22, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2019, THE PATIENT EXPERIENCED A FALL THAT CAUSED ASEPTIC LOOSENING OF THE COMPONENTS. AS A RESULT OF THIS ADVERSE EVENT, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, IN WHICH A LGN PS HIGH FLEX XLPE SZ 3-4 9MM, GII OXIN P/S FEM RIGHT SZ 6, GNS II CMT TIB SIZE 4 {} RIGHT AND A GNS II RESURF PAT 32MM WERE EXCHANGED. THE SURGEON DOES NOT BLAME THE IMPLANTS. CURRENT HEALTH STATUS OF PATIENT REMAINS UNKNOWN.

  Patient problems: Failure of Implant; Fall; Inadequate Osseointegration

  MAUDE report 18191049 ↗
• InjuryJan 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A KNEE SURGERY PERFORMED ON (B)(6) 2010, THE PATIENT HAD A FALL, SO THE DOCTOR PERFORMED A REVISION SURGERY ON (B)(6) 2022 TO REVISE THE GII OXIN P/S FEM RIGHT SZ 6 FOR BONE FRACTURE. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 16092904 ↗
• InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT; THE GII OXIN P/S FEM RIGHT SZ 6, GNS II CMT TIB SIZE 5 RIGHT, LGN PS HIGH FLEX XLPE SZ 5-6 11MM AND GNS II RESURF PAT 35MM WERE EXPLANTED. SURGEON STATED THAT THERE APPEARS TO BE NO ISSUE RELATED TO THE IMPLANTS, AS X-RAYS EXAMINATION SHOWED PROPER FIXATION. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Implant Pain; Insufficient Information

  MAUDE report 12474827 ↗
• InjuryJul 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO UN DIAGNOSED PAIN. IMPLANTS WERE ALL WELL CEMENTED SCAN WAS SHOWING SOME SIGN OF LOOSENING IN THE TIBIA AND PATELLA, HOWEVER INTRAOPERATIVELY EVERYTHING WELL FIXED.

  Patient problems: Injury; Pain

  MAUDE report 10261764 ↗
• InjuryApr 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT HAD A BILATERAL TKR PERFORMED. RECENTLY PATIENT PRESENTED WITH PAIN AND INFECTION ON HIS RIGHT SIDE TKR. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO CORRECT THE ISSUE. ALL THE IMPLANTS WERE REMOVED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9991960 ↗
• InjuryDec 15, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT HAS COMPONENTS IN PLACE SINCE (B)(6) 2015 AND WAS EXPERIENCING STIFFNESS, A REVISION SURGERY WAS PERFORMED AND EVERYTHING WAS REMOVED EXCEPT THE PATELLA.

  Patient problems: Injury

  MAUDE report 9471049 ↗
• InjurySep 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PATIENT REQUEST, NOTHING WAS FOUND TO BE WRONG WITH THE IMPLANTS. NO LOOSENING DUE TO CEMENT DEGRADATION. NO INFECTION, SKIN WAS NOT HOT TO THE TOUCH.

  Patient problems: Injury

  MAUDE report 9070338 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022010, K962557. One submission often covers many models, so check the product and lot details in each record.

• Z-0281-2025 · Oct 2, 2024 · Open, Classified
  smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic