GENESIS II 71430423Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010494481), received between Feb 28, 2021 and Jun 13, 2022 — classified as 7 malfunctions.

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

• MalfunctionJun 13, 2022Flaked; Flaked

  IT WAS REPORTED THAT GII PS HI FLEX ISRT TR S7-8 11 IS FLAKING AND CHIPPING. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT 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 14675290 ↗
• MalfunctionJun 12, 2022Flaked; Flaked

  IT WAS REPORTED THAT THEGII PS HI FLEX ISRT TR S7-8 11 IS FLAKING AND CHIPPING. IT IS UNKNOWN WHEN THIS WAS NOTICED AND IF THERE WAS A PATIENT 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 14672434 ↗
• MalfunctionJun 12, 2022Flaked; Flaked

  IT WAS REPORTED THAT GII PS HI FLEX ISRT TR S7-8 11 IS FLAKING. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT 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 14672383 ↗
• MalfunctionJun 12, 2022Flaked; Flaked

  IT WAS REPORTED THAT GII PS HI FLEX ISRT TR S7-8 11 IS FLAKING AND CHIPPING. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT 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 14672329 ↗
• MalfunctionAug 12, 2021Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT ONE (1) GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIAL SIZE 1-2 9MM, ONE (1) ECHELON 260MM POROUS BOWED FEMORAL COMPONENT STANDARD COLLAR SIZE 16 LEFT, ONE (1) GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIAL SIZE 7-8 9MM, ONE (1) GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIAL SIZE 7-8 11MM, ONE (1) GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIAL SIZE 5-6 9MM AND ONE (1) GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIAL SIZE 3-4 11MM ARE CRACKED AND WORN. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12314249 ↗
• MalfunctionJun 9, 2021Crack; Scratched Material; Crack; Scratched Material

  IT WAS REPORTED THAT 4 CONSTRAINED INSERT TRIALS, 4 ARTICULAR INSERT SPACER TRIALS, 4 POSTERIOR STABILIZED HIGH FLEXION INSET TRIALS AND 3 POSTERIOR STABILIZING ARTICULAR TRIALS FROM GENESIS II SYSTEM ARE BEING RETURNED FOR REPLACEMENT BECAUSE THEY'RE COVERED IN SCRATCHES, CHIPS AND CRACKS. NO CASE RELATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11967782 ↗
• MalfunctionFeb 28, 2021Break; Break

  IT WAS REPORTED THAT AFTER A PROCEDURE, THE GENESIS II INSERT TRIAL WAS NOTICED TO BE CHIPPED AND SCRATCHED. THIS WAS NOTICED AFTER SURGERY; THEREFORE, THE PATIENT WAS NO LONGER INVOLVED AT THAT MOMENT. 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 11391031 ↗