GENESIS II 71430768Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010213211), received between Dec 16, 2020 and Jul 26, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Crack” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 26, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A TKA SURGERY, AFTER TRIALING WITH A G2 DISH ART TR SZ3-4 11MM, IT MUST HAVE CAUGHT ON THE EDGE OF THE IMPLANT, AS A SERIES OF CHIPS WERE DISCOVERED ON THE REMOVAL AND HAD TO BE RETRIEVED FROM THE SURGICAL FIELD. SURGERY WAS FINISHED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108886 ↗
• MalfunctionDec 16, 2020Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT THE G2 DISH ART TR SZ3-4 11MM IS PRESENTING WEAR AND TEAR. IT HAS CHIPS AND CRACKS. NO CASE RELATED. 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 11017191 ↗