GENESIS II 71430449Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010512581), received between Apr 12, 2021 and Jan 3, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 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.

• MalfunctionJan 3, 2022Break; Break

  IT WAS REPORTED THAT AFTER A TKA, THE GENESIS II CR DEEP FLX ISR TR S7-8 11 BROKE DURING WASH. NO PATIENT INVOLVEMENT AT THE TIME OF THE BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13146248 ↗
• MalfunctionNov 25, 2021Break; Material Deformation; Naturally Worn; Break; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT A GENESIS II CRUCIATE RETAINING DEEP FLEXION INSERT TRIAL SIZE 5-6 9MM (CASE: (B)(4)), A GENESIS II CRUCIATE RETAINING DEEP FLEXION INSERT TRIAL SIZE 5-6 11M (CASE:(B)(4)) AND A GENESIS II CRUCIATE RETAINING DEEP FLEXION INSERT TRIAL SIZE 7-8 11M (CASE: (B)(4)) NEED REPLACING DUE TO WEAR AND TEAR, PLASTIC BURS, GOUGES, CRACKED ENDS, AMONG OTHERS. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12874425 ↗
• MalfunctionApr 12, 2021Break; Crack; Break; Crack

  IT WAS REPORTED THAT DURING INSPECTION PROCESS, THE GENESIS II CR DEEP FLX INSERT TRIAL S7-8 11 WAS NOTICED TO BE CRACKED AND CHIPPED. THERE WAS NO CASE INVOLVED. 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 11654190 ↗