GENESIS II 71430230Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010211880), received between May 20, 2019 and Sep 16, 2024 — classified as 1 injury, 8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2024Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

  IT WAS REPORTED THAT DURING A TKA SURGERY, IT WAS NOTICED THAT ONE (1) G2 INS SPAC TR SZ7-8 13MM NO LONGER CLICKED INTO THE HIGH-FLEX INSERT. 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 20226222 ↗
• MalfunctionJan 17, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, THE G2 INS SPAC TR SZ7-8 13MM BROKE IN HALF. NO PIECES FELL INTO PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18527023 ↗
• MalfunctionMay 14, 2022Break; Break

  IT WAS REPORTED THAT, A GII PS HI FLEX ISRT TR S1-2 11 AND G2 INS SPAC TR SZ7-8 18MM WERE DISCOLORED. A JRNY II BCS ART ISRT TRL SZ 3-4 9MM RT IS SCRATCHED AND BROKEN. IN ADDITION, THE FOLLOWING DEVICES HAVE SCRATCHED: G2 DISH ART TR SZ3-4 9MM, GII PS HI FLEX ISRT TR S3-4 9, GII PS HI FLEX ISRT TR S5-6 9, GII PS HI FLEX ISRT TR S3-4 11, GII PS HI FLEX ISRT TR S5-6 11 AND G2 INS SPAC TR SZ5-6 13MM. AND THE FOLLOWING DEVICES WERE BROKEN: G2 INS SPAC TR SZ7-8 13MM, TWO (2) LID FOR OUTER CASES AND A SMALL OUTER CASE - 2.4. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14403169 ↗
• MalfunctionMar 22, 2021Flaked; Naturally Worn; Flaked; Naturally Worn

  IT WAS REPORTED THAT, DURING SETUP THE STAFF WERE PREPARING FOR A GENESISII PROCEDURE AND NOTICED THAT THE G2 INS SPAC TR SZ7-8 13MM WAS DAMAGED DUE TO WEAR AND TEAR. THIS RAISED CONCERN SOMETHING MAY FLAKE INTO THE PATIENT. INCIDENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11541250 ↗
• MalfunctionJan 26, 2021Break; Break

  IT WAS REPORTED THAT, DURING INSPECTION, GENESIS II ARTICULAR INSERT SPACER TRIAL SIZE 7-8 13MM WAS NOTICED TO BE BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11229749 ↗
• MalfunctionNov 26, 2020Break; Break

  IT WAS REPORTED THAT UPON INSPECTION THE DEVICE BRIDGE AT THE TOP OF THE SPACER WAS FOUND COMPLETELY RIPPED OFF. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10909445 ↗
• MalfunctionJul 18, 2020Break; Break

  IT WAS REPORTED THAT DURING TKA SURGERY THE G2 INS SPAC TR SZ7-8 13MM BROKE OFF. A DELAY OF LESS THAN 30 MIN WAS REPORTED. A S&N BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10293457 ↗
• InjuryJun 8, 2020Break; Break

  IT WAS REPORTED THAT THE INSERT TRIAL BROKE DURING REMOVAL. SMITH&NEPHEW BACKUP DEVICE WAS AVAILABLE TO COMPLETED THE PROCEDURE. DELAY LESS OR EQUAL THAN 30 MINUTES REPORTED. IT IS UNKNOWN IF ALL PIECES WERE RETRIEVED.

  Patient problems: Injury

  MAUDE report 10127544 ↗
• MalfunctionMay 20, 2019Break; Break

  IT WAS REPORTED THAT THE SPACER BROKE DURING SURGERY. USED AN IDENTICAL BACKUP DEVICE TO COMPLETE SURGERY. SURGERY TIME WAS NOT EXTENDED MORE THAN 30 MIN. THE SURGEON DOES NOT FAULT THE DEVICE. THE PATIENT OR SURGICAL PROCEDURE WAS NOT AFFECTED IN ANY WAY DUE TO THE PROBLEM. ABSOLUTELY NO BROKEN PIECES FELL INTO THE PATIENT¿S WOUND AT ALL. TRACKING NUMBER IS NOT AVAILABLE AT THIS TIME, BUT, ITEM WILL BE RETURNED TO THE APPROPRIATE ADDRESS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8624131 ↗