GENESIS II 71430446Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010512550), received between Nov 5, 2020 and Nov 6, 2023 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) GII CR DEEP FLX ISR TR S5-6 9 BROKE IN HALF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18075114 ↗
• MalfunctionJun 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A CHUNK OF THE PLASTIC OF ONE (1) GII CR DEEP FLX ISR TR S5-6 9, BROKE OFF WHILE TRYING TO REMOVE IT FROM THE PATIENT. THE PROCEDURE HAD BEEN COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17242628 ↗
• MalfunctionOct 12, 2022Break; Break

  IT WAS REPORTED THAT, ONE (1) GII CR DEEP FLX ISR TR S5-6 9 IS BROKEN. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15592095 ↗
• 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 5-6 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 14740075 ↗
• MalfunctionMar 17, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GII CR DEEP FLX ISR TR S5-6 9 BROKE. NO PIECES FELL INTO PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS ISSUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13791943 ↗
• MalfunctionDec 3, 2021Crack; Crack

  IT WAS REPORTED THAT THE GII CR DEEP FLX ISR TR S5-6 9 IS CRACKED. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12924864 ↗
• 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 (B)(4). A GENESIS II CRUCIATE RETAINING DEEP FLEXION INSERT TRIAL SIZE 5-6 11M (B)(4) AND A GENESIS II CRUCIATE RETAINING DEEP FLEXION INSERT TRIAL SIZE7-8 11M (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 12874400 ↗
• MalfunctionSep 14, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GENESIS II CRUCIATE RETAINING DEEP FLEXION INSERT TRIAL SIZE 5-6 9MM BROKE OFF. INSTRUMENTS WERE OUTSIDE THE PATIENT. SURGERY WAS COMPLETED WITH A BACK UP DEVICE INSTEAD, WITHOUT ANY DELAY. NO HARM TO THE PATIENT OR ANY FURTHER COMPLICATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12472086 ↗
• MalfunctionMar 23, 2021Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT IT WAS NOTICED DURING INSPECTION THAT THE TRIAL INSERT IS SCRATCHED AND CHIPPED. NO CASE OR PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11552443 ↗
• MalfunctionNov 5, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE TRIAL SNAPPED IN HALF. NOTHING FELL INTO PATIENT AND ALL PIECES WERE RECOVERED. NO HARM OR INJURY REPORTED ON PATIENT. PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10791079 ↗