GENESIS 71210003Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010185747), received between May 5, 2018 and Apr 11, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2024Fracture; Difficult or Delayed Separation; Fracture; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A CORI-ASSISTED TKA, WHILE INSERTING THE GNS TROCAR PIN 1/8 IN. X {} 5IN INTO THE TWIN PEG BLOCK, DID NOT MAKE IT FAR ENOUGH THROUGH THE TWIN PEG BLOCK TO MAKE A BONE HOLE BEFORE IT WAS COLD WELDED AND BROKE OFF. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19088723 ↗
• InjuryMay 5, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  BOX OF PINS WAS OPENED TO REVEAL ONE PIN HAD PIERCED PLASTIC PROTECTIVE END AND THROUGH PLASTIC PACKAGE AS WELL. SCRUB NURSE WAS PRICKED BY EXPOSED SHARP END.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7489384 ↗