GENESIS II 71421542Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010512475), received between Dec 27, 2018 and Jan 31, 2024 — classified as 8 injuries.

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

• InjuryJan 31, 2024Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2023 ON A PATIENT´S RIGHT KNEE, PATIENT EXPERIENCED A CONSTANT PAIN AFTER 2 MONTHS OF OPERATION. THE JOINT BEGAN TO RATTLE AND CRACK, THESE NOISES OCCUR WITH EVERY MOVEMENT. THE PATIENT IS NOW WALKING AGAIN WITH CRUTCHES AFTER 8 MONTHS. THERE IS A VERY GOOD RANGE OF MOTION OF THE ENTIRE KNEE JOINT UP TO 130 DEGREES, BUT A CLEAR BAND INSTABILITY BOTH MEDIALLY AND LATERALLY. REVISION SURGERY STILL PENDING DUE TO MISSING EXAMINATION BY A CARDIOLOGIST. EVENT IS ONGOING.

  Patient problems: Ambulation or Postural Difficulties; Arthralgia; Joint Laxity

  MAUDE report 18619240 ↗
• InjuryApr 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON THE (B)(6) 2016, THE PATIENT WAS TRYING TO DRIVE A RIDE ON MOWER UP A RAMP AND ONTO A TRAILER. THE MOWER FELL OFF THE RAMP AND PINNED HIS LEG UNDER THE RIDE ON MOWER. THE PATIENT HAD TO PUT EXCESSIVE VARUS FORCE TO REMOVE LEG FROM UNDERNEATH THE MOWER AND FELT SOMETHING CRACK AND HAD LOCALISED PAIN ON THE MEDIAL SIDE OF THE KNEE JOINT. THE PATIENT SOMETIMES COULD SEE SOMETHING PROTRUDING FROM HIS KNEE JOINT AND WOULD PUSH IT BACK IN. THE PHYSICIAN SUSPECTED THAT THE GII CR DEEP FLEX ISRT S5-6 9M HAD FRACTURED. THE PATIENT WAS REVISED AND THE POLY WAS INTAKE; THE PATIENT ALSO HAD SEVERAL LARGE LOOSE BODIES IN THE JOINT WHICH WERE REMOVED. THE PHYSICIAN ALSO DECIDED TO RESURFACE THE PATELLA. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 14209614 ↗
• InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT THAT REQUIRED A REVISION SURGERY. ALTHOUGH THE SURGEON ORIGINALLY BELIEVED THE SURGERY MAY ONLY BE AN IRRIGATION & DEBRIDEMENT WITH A S5-6 9MM GII CR DEEP FLEX INSERT EXCHANGE, UPON OPENING THE JOINT HE FOUND AND DETERMINED THE FEMUR WOULD ALSO NEED TO BE EXCHANGED. A SIZE 6 OXINIUM LEGION REVISION FEMUR WITH A 12X120 CEMENTED STEM AND A SIZE 5-6 SIZE 11 MM LEGION PS TIBIAL INSERT WERE IMPLANTED. THE TIBIAL COMPONENT SHOWED WEAR ON THE ANTERIOR-MEDIAL ASPECT OF THE IMPLANT, BUT IT WAS DETERMINED THE LOCKING MECHANISM WAS INTACT AND FUNCTIONING SO THE SURGEON WAS ABLE TO IMPLANT A NEW TIBIAL INSERT AND KEEP THE TIBIAL PROSTHESIS. THE PATIENT OUTCOME IS POSITIVE.

  Patient problems: Failure of Implant

  MAUDE report 11572491 ↗
• InjuryDec 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT WHEN THE PATIENT FELL, HE REOPENED THE SURGICAL SCAR, WHICH WAS TREATED WITH A COVERING AND BECAME INFECTED. HE UNDERWENT FURTHER SURGERY TO DEBRIDE INFECTED TISSUE, INSPECTED AND WASH OUT TO THE JOINT AND REPLACED THE POLY INSERT. THE TIBIAL AND FEMORAL COMPONENTS WERE EXAMINED AND FOUND TO BE INTACT AND WELL ADHERED. NO OPERATIVE REPORTS ARE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 9414240 ↗
• InjurySep 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD STIFFNESS AND A REVISION SURGERY WAS PERFORMED TO REMOVE FEMORAL COMPONENT AND INSERT .

  Patient problems: Injury; Muscular Rigidity

  MAUDE report 9017438 ↗
• InjurySep 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH AN UNSPECIFIED MEDICATION/ORTHOTICS AND WAS HOSPITALIZED DUE TO A SUPERFICIAL WOUND INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8967561 ↗
• InjuryAug 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AND UNDERWENT A WASHOUT DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8931577 ↗
• InjuryDec 27, 2018Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO IMPLANT INSTABILITY. DELAY OF 30MIN REPORTED. REPLACED WITH S&N COMPONENTS.

  Patient problems: Injury

  MAUDE report 8201277 ↗