GENESIS II 71440468Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010215642), received between Aug 12, 2019 and May 7, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K123598); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 7, 2021Break; Break

  IT WAS REPORTED THAT, DURING OFFICE INSPECTION, IT WAS FOUND THAT THE TENSIONER FLANGE ON THE GENESIS II FEMORAL TRIAL IMPACTOR HAS BROKEN OFF. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794938 ↗
• MalfunctionFeb 15, 2021Break; Break

  IT WAS REPORTED THAT DURING INSPECTION THE GNS II FEMORAL TRIAL IMPACTOR WAS FOUND BROKEN. UNKNOWN WHEN THIS EVENT HAPPENED AND IF THERE IS A PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326351 ↗
• MalfunctionAug 2, 2020Break; Break

  IT WAS REPORTED THAT DURING TKA PROCEDURE THE GNS II FEMORAL TRIAL IMPACTOR BROKE. THIS HAPPENED DURING USE OUTSIDE THE PATIENT. NO DELAY. PROCEDURE COULD BE FINISHED USING THE SAME DEVICE. PATIENT INJURIES WERE NOT REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10354407 ↗
• MalfunctionAug 12, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE IMPACTOR BROKE DURING INSERTION OF IMPLANT. DELAY OF ALMOST AN HOUR. BACKUP DEVICE FROM SMITH AND NEPHEW AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8884098 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123598. One submission often covers many models, so check the product and lot details in each record.

• Z-0730-2019 · Jan 7, 2019 · Terminated
  SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
• Z-1008-2017 · Nov 16, 2016 · Terminated
  REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116