GENESIS II 71421032Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 03596010485069), received between Apr 20, 2017 and Apr 29, 2025 — classified as 30 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (12 reports).

6 other recalls cover devices cleared under the same FDA submission (K951987); they may or may not involve this specific model.

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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A LOOSENING OF THE (1) GII OVAL RESURFACING PAT 32MM. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE (1) GII OVAL RESURFACING PAT 32MM AND THE (1) LGN PS HIGH FLEX XLPE SZ 5-6 13MM WERE EXCHANGED. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN.

  Patient problems: Aseptic loosening

  MAUDE report 21931859 ↗
• InjuryApr 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  T WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED A FALL AND STARTED TO DEVELOP ANTERIOR KNEE PAIN. AFTER A BONE SCAN, IT SHOWED LOOSENING OF ONE (1) GII OVAL RESURFACING PAT 32MM. THIS ADVERSE EVENT WAS RESOLVED THROUGH REVISION SURGERY BY CEMENTING ANOTHER PATELLA. THE PATIENT¿S CURRENT STATE IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 21870344 ↗
• InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED OSTEONECROSIS OF AN ORIGINALLY WELL PLACED UNKN GENESIS II TOTAL KNEE PAT COMP. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2023. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Necrosis

  MAUDE report 17167351 ↗
• MalfunctionNov 4, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GII OVAL RESURF PAT TRIAL 32MM DEVICE WAS FOUND TO BE GOUDED OUT FROM USE AND PLASTICS BITS WERE COMING OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15724386 ↗
• InjuryApr 5, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED ON (B)(6) 2019, THE PATIENT WAS BROUGHT INTO SURGERY DUE TO THE PATIENT FELL CAUSING THE PATELLA TO BECAME LOOSE. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2022, TO EXCHANGED THE GII OVAL RESURFACING PAT 32MM. IN ADDITION, DR. REPLACED THE LGN PS HIGH FLEX XLPE SZ 3-4 9MM, IS UNKNOWN IF THERE WAS ANY FAULT NOTICED IN THE INSERT. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 14018412 ↗
• InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA ON (B)(6) 2021, PATIENT HAD A FALL AND FRACTURED THE PATELLA BONE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO REVISED A GII OVAL RESURFACING PAT 32MM. IMPLANT WAS NOT LOOSE BUT WAS REVISED DUE TO THE UNCERTAINTY OF THE FIXATION POST FRACTURE. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Vertebral Fracture

  MAUDE report 13548985 ↗
• MalfunctionDec 28, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING A TKA, SURGEON HAD PREPARED EVERYTHING FOR THE GENESIS II OVAL RESURFACING PATELLAR 32MM BUT DUE TO MISMATCH OF THE FINAL IMPLANT PEGS AND THE PREPARED PEGS SURGEON HAD TO PREPARE AGAIN FOR A 29 SIZE PATELLA AND 29 SIZE IMPLANT. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13094555 ↗
• InjuryApr 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT HAD A BILATERAL TKR PERFORMED. RECENTLY PATIENT PRESENTED WITH PAIN AND INFECTION ON HIS RIGHT SIDE TKR. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO CORRECT THE ISSUE. ALL THE IMPLANTS WERE REMOVED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9992077 ↗
• InjuryApr 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT PRESENTED STIFFNESS OF LEFT KNEE. EVENT WAS TREATED WITH MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 9951760 ↗
• InjuryNov 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A TKR WAS PERFORMED ON THE RIGHT KNEE LAST (B)(6) 2018. THE PATIENT IS IN PAIN AND SWELLING. SHE IS NOT ABLE TO WALK. X-RAYS AND TESTS ATTACHED.

  Patient problems: Pain

  MAUDE report 9293536 ↗
• InjuryNov 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A TKR WAS PERFORMED ON THE LEFT KNEE LAST (B)(6) 2018. THE PATIENT IS IN PAIN AND SWELLING. SHE IS NOT ABLE TO WALK. X-RAYS AND TESTS ATTACHED.

  Patient problems: Pain

  MAUDE report 9293535 ↗
• InjuryMay 31, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ACCORDING TO PHYSICIAN DEEMED IMPLANTS TO BE LOOSE. REMOVED THEM AND REPLACED THEM WITH LEGION. NO MORE INFORMATION PROVIDED YET.

  Patient problems: Injury

  MAUDE report 8660075 ↗
• InjuryMay 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED BILATERAL PULMONARY EMBOLISM AFTER RIGHT TOTAL KNEE ARTHROPLASTY FOR WHICH HOSPITALIZATION AND MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT HAD TO RECEIVE REMEDIAL THERAPY TO RESOLVE THE ADVERSE EVENT.

  Patient problems: Pulmonary Embolism

  MAUDE report 8600429 ↗
• InjuryMay 6, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LIMITED RANGE OF MOTION AFTER RIGHT TOTAL KNEE ARTHROPLASTY FOR WHICH MANIPULATION UNDER ANESTHESIA WAS PERFORMED.

  Patient problems: Injury

  MAUDE report 8584926 ↗
• InjuryApr 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD ATRIAL FIBRILLATION WHICH WAS TREATED WITH MEDICATION AND HOSPITALISATION WAS PROLONGED.

  Patient problems: Injury

  MAUDE report 8534370 ↗
• InjuryApr 21, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT PATIENT HAD PERSISTENT STIFFNESS IN RIGHT KNEE AFTER SURGERY. FOR THIS EVENT SUBJECT UNDERWENT MOBILISATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 8534368 ↗
• InjuryApr 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD DIFFICULT REHABILITATION. PATIENT WAS HOSPITALISED AND UNDERWENT MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 8534359 ↗
• InjuryApr 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER A TKA PROCEDURE, PATIENT EXPERIENCED PAIN IN HIS RIGHT KNEE. NO SIGNS OF NEUROPATHIC PAIN. KNEE WAS WARM AND SWOLLEN. PATIENT REQUIRED HOSPITALIZATION. NO SPECIFIC COMPONENT OF THE TOTAL KNEE SYSTEM WAS ASSESSED AS TO BE THE MAIN COMPLAINED DEVICE.

  Patient problems: Pain

  MAUDE report 8479205 ↗
• InjuryMar 6, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  REMAINING LOSS OF FUNCTION AND LIMITED FLEXION AND EXTENSION AFTER TKA LEFT. SUBJECT WAS HOSPITALISED AND UNDERWENT MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 8395663 ↗
• InjuryFeb 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A REVISION SURGERY WAS PERFORMED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8374623 ↗
• InjuryFeb 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED SWELLING AND REDNESS IN THE RIGHT KNEE. THE CAUSE OF THE SWELLING AND REDNESS IS UNKNOWN. THE PATIENT WAS PRESCRIBED TO TAKE REST AND MEDICATION THERAPY.

  Patient problems: Swelling

  MAUDE report 8352795 ↗
• InjuryFeb 6, 2019Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A LEFT TKA HAD BEEN PERFORMED ON (B)(6) 2018 WITH A JOURNEY II XR SYSTEM, THE GII OVAL RESURFACING PAT 32MM FRACTURED. ON (B)(6) 2019, THE CLINICAL INVESTIGATOR HAD INITIALLY ASSESSED THIS ADVERSE EVENT AS NON-SERIOUS, SO THE PATIENT WAS ADVISED TO REST. ON (B)(6) 2019, THE KNEE WAS ASPIRED. LATER ON, A SYNOVECTOMY WAS PERFORMED ON (B)(6) 2019. ON (B)(6) 2021, THE SERIOUSNESS OF THE EVENT WAS RE-ASSESSED AS THE PATIENT REQUIRED A REVISION SURGERY. THE PATIENT CLAIMS THAT THE EXPERIENCE WITH JOURNEY II XR HAS LEFT HIM WITH MORE PAIN, LESS FUNCTION, AND LESS STRENGTH THAN PRIOR TO HAVING ANY TKA.

  Patient problems: Failure of Implant; Inadequate Pain Relief; Injury; Loss of Range of Motion; Muscle Weakness/Atrophy; Synovitis

  MAUDE report 8312429 ↗
• InjuryMay 30, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY ON THE LEFT KNEE DUE TO PAIN AND STIFFNESS. PROPERATIVE FILMS REVEALED A POSSIBLE LOOSENING OF THE PATELLAR IMPLANT AND SIGNIFICANT HETEROTOPIC OSSIFICATION, BOTH WERE CONFIRMED DURING REVISION. ONLY THE PATELLAR COMPONENT WAS REVISED.

  Patient problems: Injury; Pain

  MAUDE report 7555300 ↗
• InjuryMay 30, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT A JOINT/BURSA ASPIRATION OF THE LEFT KNEE DUE TO PAIN AND STIFFNESS. IT IS SUSPECTED THAT THE PATELLAR COMPONENT WAS THE MAIN FACTOR OF THIS SYMPTOMS.

  Patient problems: Injury; Pain

  MAUDE report 7555298 ↗
• InjuryApr 3, 2018Misassembled; Misassembled

  IT WAS REPORTED THAT PATIENT WAS OPERATED ON (B)(6) 2012 AND AFTER 6 YEARS PATELLA WAS SLIGHTLY LATERALIZED. ONE OF THE THREE PLUGS IN THE PATELLA COME OUT FROM THE IMPLANT.

  Patient problems: Failure of Implant

  MAUDE report 7391320 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K951987. One submission often covers many models, so check the product and lot details in each record.

• Z-1418-2022 · Jun 27, 2022 · Terminated
  (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.
• Z-2774-2020 · Jul 16, 2020 · Open, Classified
  Tibial knee prosthesis
• Z-2883-2018 · Aug 1, 2017 · Terminated
  GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
• Z-0573-2016 · Nov 9, 2015 · Terminated
  Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490 kn
• Z-0130-2014 · Oct 7, 2013 · Terminated
  GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic
• Z-0131-2014 · Oct 7, 2013 · Terminated
  GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic