GENESIS II 71440471Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556034798), received between Mar 29, 2021 and Oct 15, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (2 reports).

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.

• MalfunctionOct 15, 2022Degraded; Material Fragmentation; Degraded; Material Fragmentation

  IT WAS REPORTED THAT, DURING THE SET UP AND INSPECTION FOR A TKA SURGERY, THE ANTERIOR PORTION OF A GII SPC CONS INS TRL S 1-2 9MM WAS NOTICED TO BE CHIPPED AND WORN AWAY, MAKING IT DIFFICULT TO REMOVE POLY AFTER TRIALING.THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. SINCE INCIDENT WAS NOTICED BEFORE PROCEDURE, PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15612582 ↗
• MalfunctionAug 22, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A PIECE OF THE GII SPC CONS INS TRL S 1-2 9MM HAS BEEN CHIPPED OFF ON THE UNDERSIDE OF THE TRIAL. AS THIS WAS NOTICED IN A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15266919 ↗
• MalfunctionMar 29, 2021Break; Break

  IT WAS REPORTED THAT, DURING INSPECTION IT WAS NOTICED THAT THE LEGION INSPECTION TRIALS AND IMPACTOR ARE BUSTED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11586418 ↗