GENESIS II 71421547Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010512505), received between May 20, 2018 and Sep 13, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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.

• InjurySep 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD IMPINGING SCAR TISSUE AND EFFUSION WITH SOME SYNOVITIS. IT WAS RESOLVED THROUGH AN ARTHROSCOPY OF LEFT KNEE REPLACEMENT WITH DEBRIDEMENT OF A SYNOVIAL FOLD AND SCAR TISSUE IN THE MEDIAL GUTTER.

  Patient problems: Injury

  MAUDE report 9050708 ↗
• InjuryAug 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AND WAS TREATED WITH AN UNSPECIFIED MEDICATION/ORTHOTICS DUE TO A WOUND INFECTION ON THE RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 8931564 ↗
• InjuryMay 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A WASHOUT WAS PERFORMED DUE TO INFECTION, THE INSERT WAS CHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 7528651 ↗