GENESIS II 71421536Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010512444), received between Jul 18, 2017 and Mar 7, 2025 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2025Material Erosion; Material Erosion

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2009, THE PATIENT EXPERIENCED A KNEE PAIN DUE TO A LATERAL FEMORAL CONDYLE WEAR IN FEMUR BECAUSE OF POLYETHYLENE WEAR AND THE METAL FEMUR WAS RUBBING ON THE TITANIUM BASEPLATE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH A GII CR DEEP FLEX ISRT S3-4 9M AND A GII OXINIUM FEM SIZE 6 RIGHT WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Implant Pain; Pain

  MAUDE report 21548494 ↗
• InjuryJul 21, 2022Material Erosion; Material Erosion

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED IN 2007, THE GII CR DEEP FLEX ISRT S3-4 9M WORN THROUGH ON MEDIAL SIDE. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON (B)(6) 2022 TO REPLACE THE DEVICE. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 15072242 ↗
• InjuryJul 1, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GENESIS II CRUCIATE RETAINING DEEP FLEXION INSERT SIZE 3-4 9 MM BROKE INTERNAL TO PATIENT. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS PROBLEM. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12099786 ↗
• MalfunctionAug 18, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A KNEE REPLACEMENT SURGERY, WHILE IMPLANTING THE 3-4 9MM INSERT, THE INSERT COULDN'T BE LOCKED WELL WITH BASE PLATE. A SAME CODE INSERT WAS USED TO COMPLETE THE SURGERY. A DELAY OF LESS THAN 30 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10423613 ↗
• InjurySep 13, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT PATIENT HAD STIFFNESS AND ARTHROFIBROSIS, AND MANIPULATION UNDER ANESTHESIA WAS PERFORMED TO RESOLVE THE EVENT.

  Patient problems: Injury

  MAUDE report 9050780 ↗
• InjuryAug 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS ON THE LEFT KNEE.

  Patient problems: Injury

  MAUDE report 8931575 ↗
• InjuryOct 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY OF THE PE INSERT WAS PERFORMED DUE TO INFECTION 16 MONTHS AFTER PRIMARY SURGERY. AFTER THE DEVICE WAS EXPLANTED, IT WAS NOTICED IT APPEARS TO BE YELLOWISH. TO TREAT THE INFECTION AN IMPLANTATION OF CEMENT SPACER WAS PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 8017260 ↗
• InjuryJul 18, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE TOTAL KNEE INSERT REVISED DUE TO KNEE INSTABILITY.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 6721522 ↗