GENESIS II 71430409Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 03596010493040), received between Jul 12, 2020 and Sep 2, 2022 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Crack” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2022Degraded; Fracture; Degraded; Fracture

  IT WAS REPORTED THAT A GII PS HI FLEX ISRT TR S3-4 11 IS NOT SUITABLE FOR USE AS THE PLASTIC HAS CHIPPED OFF. AS THIS WAS NOTED IN A NON-SURGICAL SETTING, THERE WERE NO PATIENTS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15351084 ↗
• MalfunctionSep 2, 2022Fracture; Fracture

  IT WAS REPORTED THAT GII PS HI FLEX ISRT TR S3-4 11 IS CHIPPED AND HAVE CRACK. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15350404 ↗
• MalfunctionJun 12, 2022Flaked; Flaked

  IT WAS REPORTED THAT THE GII PS HI FLEX ISRT TR S3-4 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 14672392 ↗
• MalfunctionJun 12, 2022Flaked; Flaked

  IT WAS REPORTED THAT GII PS HI FLEX ISRT TR S3-4 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 14672333 ↗
• MalfunctionJun 11, 2022Flaked; Flaked

  IT WAS REPORTED THAT GII PS HI FLEX ISRT TR S3-4 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 14671754 ↗
• MalfunctionJun 11, 2022Flaked; Flaked

  IT WAS REPORTED THAT GII PS HI FLEX ISRT TR S3-4 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 14671541 ↗
• MalfunctionJun 8, 2022Crack; Material Fragmentation; Crack; Material Fragmentation

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, SEVEN (7) GII PS HI FLEX ISRT TR S3-4 11 WERE CHIPPED AND CRACKED INSIDE THE PATIENT. SURGERY WAS RESUMED BY CHANGING THE SURGICAL TECHNIQUE. IT IS UNKNOWN IF ANY DELAY OCCURRED AS A CONSEQUENCE OF THIS ISSUE. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14629564 ↗
• MalfunctionDec 6, 2021Crack; Crack

  IT WAS REPORTED THAT THE GII PS HI FLEX ISRT TR S3-4 11 WAS 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 12941106 ↗
• MalfunctionSep 14, 2021Flaked; Naturally Worn; Flaked; Naturally Worn

  IT WAS REPORTED THAT A GENESIS II PS HI FLEX INSERT TRIAL SIZE 3-4 11MM IS CHIPPED AND WORN OUT. AS THIS WAS NOTICED IN A WAREHOUSE UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12469242 ↗
• 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 12314295 ↗
• MalfunctionJun 24, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING A TKA, SEVEN (7) GENESIS II PS HI FLEX INSERT TRIALS ARE CHIPPED AND CRACKED INSIDE THE PATIENT. SURGERY WAS RESUMED, WITH A DELAY LESS THAN OR EQUAL TO 30MIN, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12059686 ↗
• 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 11967680 ↗
• MalfunctionJun 8, 2021Break; Break

  IT WAS REPORTED THAT AFTER SURGERY THE GII PS HI FLEX ISRT TR S3-4 9 WAS DISCOVERED TO BE WORN. NO PATIENT HARM OR SURGICAL DELAY WAS REPORTED. AFTER VISUAL INSPECTION OF THE DEVICE IT WAS FOUND THAT ONE OF THE LATCHES OF THE GII PS HI FLEX ISRT TR S3-4 11 (CASE: (B)(6)) FRACTURED OFF THE DEVICE, RENDERING IT INOPERABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11962415 ↗
• MalfunctionMar 2, 2021Break; Break

  IT WAS REPORTED THAT GENESIS II PS HI FLEX INSERT TRIAL WAS CHIPPED, WITH PLASTIC LAYERS COMING OFF. THIS WAS NOTICED AFTER SURGERY; THEREFORE, THE PATIENT WAS NO LONGER INVOLVED AT THAT MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11401858 ↗
• MalfunctionMar 2, 2021Break; Break

  IT WAS REPORTED THAT GENESIS II PS HI FLEX INSERT TRIAL WAS CHIPPED, WITH PLASTIC LAYERS COMING OFF. THIS WAS NOTICED AFTER SURGERY; THEREFORE, THE PATIENT WAS NO LONGER INVOLVED AT THAT MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11401833 ↗
• MalfunctionJul 12, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING TKA SURGERY THE BOTTOM OF GII PS HI FLEX ISRT TR S3-4 11 WAS FOUND TO BE CHIPPED. NO DELAY. PROCEDURE WAS FINISHED USING A S&N BACK UP DEVICE. NO INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10262216 ↗