GENESIS II 71433444Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556480021), received between Sep 1, 2020 and Sep 9, 2020 — classified as 1 injury, 1 malfunction.

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

• InjurySep 9, 2020Break; Break

  IT WAS REPORTED THAT THE LEGION TKA TIBIAL INSERT TRIAL BROKE DURING USE. ALL PARTS WERE REMOVED FROM THE PATIENT. THE TREATMENT FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED AT THIS TIME. NO DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10511175 ↗
• MalfunctionSep 1, 2020Break; Break

  IT WAS REPORTED THAT THE GII CR DEEP FLX ISR TR S3-4 12 WAS FOUND TO BE BROKEN DURING A ROUTINE EFIP INSPECTION. NO CASE RELATED THEREFORE NO PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10480072 ↗