GENESIS II 71421017Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010469236), received between Jul 6, 2018 and Sep 15, 2024 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON AN UNSPECIFIED DATE, A FIRST STAGE REVISION SURGERY DUE TO INFECTION WAS PERFORMED ON (B)(6) 2024, IN WHICH A GII OXIN P/S FEM LT SZ 7, A GNS II CMT TIB SIZE 7 {} LEFT, AND A GII PS HI FLEX ISRT SZ 5-6 11 WERE REMOVED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 20220953 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA ON (B)(6) 2023, A REVISION SURGERY WAS PERFORMED ON DUE TO INFECTION. ALL GNS II IMPLANTS WERE REMOVED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 20151503 ↗
• InjuryApr 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA REVISION SURGERY HAD BEEN PERFORMED ON (B)(6) 2015, THE PATIENT EXPERIENCED PAIN. THE PHYSICIAN MENTIONED THAT THE LGN REV TIBIA BASE SZ 5 LT WAS SHOWING RED ON THE BONE SCAN REPORT AND THAT THE TKR REPLACEMENT WAS MOST LIKELY INFECTED; THEREFORE, AN ANTIBIOTIC SPACER WAS NEEDED. THIS ADVERSE EVENT WAS SOLVED BY A THIRD REVISION SURGERY ON (B)(6) 2022, IN WHICH THE GII OXIN P/S FEM LT SZ 7 WAS EXPLANTED, AND GII IMPLANTS WERE IMPLANTED WITH ANTIBIOTICS. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Implant Pain; Unspecified Infection

  MAUDE report 13996231 ↗
• InjuryAug 28, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING AND POSSIBLE INFECTION.

  Patient problems: Injury

  MAUDE report 8940116 ↗
• InjuryJul 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO CORRECT PATIENTS DISCOMFORTS. SURGEON DETERMINED THIS PATIENT HAD A "LACK OF FLEXION" IN HIS KNEE.

  Patient problems: Injury

  MAUDE report 7667884 ↗

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