GENESIS II 71430448Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010512574), received between Feb 6, 2019 and Mar 14, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2026Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) GII CR DEEP FLX ISR TR S7-8 9 FRACTURED IN TWO PIECES DURING TRIALING, AND NO PIECES FELL INSIDE THE INCISION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24600289 ↗
• MalfunctionJun 18, 2022Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT, GENESIS II CRUCIATE RETAINING DEEP FLEXION INSERT TRIAL SIZE 7-8 9MM IS CHIPPED AND BURRED. AS THIS WAS NOTICE IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14740080 ↗
• MalfunctionJun 6, 2022Break; Break

  IT WAS REPORTED THAT A GENESIS II CRUCIATE RETAINING DEEP FLEXION INSERT TRIAL SIZE7-8 9MM WAS FOUND TO BE BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14611024 ↗
• MalfunctionFeb 18, 2022Break; Break

  IT WAS REPORTED THAT A GII CR DEEP FLX ISR TR S7-8 9 BROKE IN HALF. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559355 ↗
• MalfunctionJul 22, 2020Break; Break

  IT WAS REPORTED THAT DURING A ROUTINE EFIP INSPECTION, THE GENESIS II CRUCIATE RETAINING DEEP FLEXION INSERT TRIAL WAS BROKEN IN HALF AND THE FEMORAL IMPLANT IMPACTOR HAD A PLASTIC TIP BROKEN OFF. NO PATIENT WAS INVOLVED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10308072 ↗
• MalfunctionJul 19, 2020Break; Break

  IT WAS REPORTED THAT DURING STANDARD OFFICE EFIP INSPECTION GENESIS II CRUCIATE RETAINING DEEP FLEXION INSERT TRIAL SIZE 8-9 MM (71430448) WAS FOUND WITH THE PLASTIC CRACKED AN CHIPPED. NO CASE INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10293848 ↗
• MalfunctionFeb 6, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE LOCKING DETAIL BROKE OFF OF TRIAL DURING RANGE OF MOTION. THE PROCEDURE WAS COMPLETED WITH NO DELAY. IT IS UNKNOWN IF THERE WAS AFFECTATION TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8312143 ↗