GENESIS II 71430332Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010481283), received between Jan 10, 2020 and Sep 9, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GII ART INS SPCR TRL 1-2 15MM CRACKED. THE SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. IT IS UNKNOWN IF ANY PIECE OF THE BROKEN DEVICE FELL INSIDE THE PATIENT. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396617 ↗
• MalfunctionJun 29, 2021Break; Break

  IT WAS REPORTED THAT DURING A CONSIGNMENT INSPECTION THE DEVICE WAS FOUND WITH BURRS/NICKS/SCRATCHES/GOUGES. NO PATIENT WAS INVOLVED. THE INVESTIGATION FOUND THAT THE TRIAL WAS CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12088663 ↗
• MalfunctionApr 9, 2021Break; Break

  IT WAS REPORTED THAT DURING A CONSIGNMENT INSPECTION THE DEVICE WAS FOUND WITH CORROSION/DISCOLORATION. THE DEVICE WILL BE RETURNED. THE INVESTIGATION FOUND THAT THERE WERE LITTLE PIECES BREAKING OFF IN CERTAIN AREAS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11642702 ↗
• MalfunctionNov 11, 2020Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE GII ART INS SPCR TRL 1-2 15MM WAS FOUND WITH A HOLE. THIS WAS DISCOVERED WHILE RESETTING THE TRAYS. NO CASE RELATED THEREFORE NO PATIENT INVOLVED. RESULTS OF INVESTIGATION CONCLUDED THAT THE DEVICE HAS A FRACTURED PIECE. 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 10825247 ↗
• MalfunctionJan 10, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE INSERT TRIAL BROKE WHEN IMPACTING. NO DELAY WAS REPORTED AND A BACKUP DEVICE WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9578275 ↗