GENESIS II 71420172Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 03596010206299), received between Jan 29, 2018 and Apr 12, 2024 — classified as 16 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 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. 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryApr 12, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED (B)(6) 2016, A GNS II CMT TIB SIZE 7 {} LEFT HAD TO BE REVISED ON (B)(6) 2024 DUE TO LOOSENING OF THE COMPONENT. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19098666 ↗
• InjuryMar 12, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A REVISION TKA PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE DUE TO ACUTE PCL RUPTURE, THE PATIENT EXPERIENCED ASEPTIC LOOSENING. A SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, IN WHICH ONE (1) GNS II CMT TIB SIZE 7 {} LEFT AND ONE (1) LGN PS HIGH FLEX XLPE SZ 7-8 9MM WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18888015 ↗
• InjuryApr 4, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, THE PATIENT EXPERIENCED ASEPTIC LOOSENING OF THE GNS II CMT TIB SIZE 7 {} LEFT. A REVISION SURGERY WAS PERFORMED TO ADDRESS THIS ADVERSE EVENT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16678885 ↗
• InjuryFeb 17, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A LEFT TKA HAD BEEN PERFORMED ON (B)(6) 2010 WITH OSTEOARTHRITIS AS PRIMARY DIAGNOSIS, THE PATIENT REQUIRED A REVISION SURGERY ON (B)(6) 2015 DUE TO THE FOLLOWING DIAGNOSIS/COMPLICATION(S): ASEPTIC LOOSENING OF THE TIBIAL BASEPLATE, LYSIS AROUND THE TIBIAL BASEPLATE, UNEXPLAINED PAIN AND IMPLANT FRACTURE. DURING THIS PROCEDURE, ALL THE COMPONENTS (FEMORAL, TIBIAL AND INSERT) WERE EXPLANTED AND REPLACED WITH A SMITH + NEPHEW KNEE REVISION SYSTEM, INCLUDING A PATELLAR REPLACEMENT. PER THE REGISTRY REPORT CONTENTS, IT IS NOT SPECIFIED WHICH OF THE EXPLANTED KNEE PROSTHESIS COMPONENTS FRACTURED. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A PRIMARY TKR SURGERY WITH A KNEE PROSTHESIS CONSTRUCT THAT INCLUDED A GENESIS II OXONIUM FEMORAL COMPONENTS AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Osteolysis; Pain

  MAUDE report 16395943 ↗
• InjurySep 3, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, AFTER A TKR SURGERY HAD BEEN PERFORMED ON (B)(6) 2020, THE GNS II CMT TIB SIZE 7 LEFT BECAME LOOSE. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12422520 ↗
• InjuryJun 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKR ON 2019, THE PATIENT WAS EXPERIENCING PAIN, THEREFORE, THE SURGEON DECIDED TO REVISE THE TIBIAL BASEPLATE ONLY. THE SURGEON REPORTED THAT THE X-RAY WAS SHOWING THAT THE TKR WAS STILL IN VALGUS AND THE BEST OPTION WAS TO RECUT THE TIBIA IN VARUS WITH THE ADDITION OF A STEM. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021, TO REMOVE POLY TO IMPROVE ACCESS, REMOVED TIBIAL BASEPLATE WITH FLEXIBLE OSTEOTOME. ONCE TIBIAL IMPLANTS WERE REMOVED, EXTRAMEDULLARY JIG USED TO PERFORM NEW TIBIAL BONE CUTS. STEM WAS PREPARED FOR AS PER SURGICAL TECHNIQUE. SIZE 18MM DISHED INSERT WAS TRIALED FOR. BASEPLATE WITH 10MM X 100MM STEM INSERTED WITH 18MM DISHED POLY. SURGEON WAS HAPPY WITH STABILITY AND RANGE OF MOTION. PATIENT WAS NOT HARMED.

  Patient problems: Pain

  MAUDE report 11996108 ↗
• InjuryMay 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 AND THE LEGION PS OXIN FEM SZ7 LT ((B)(4)), THE GNS II CMT TIB SIZE 7 LEFT ((B)(4)) AND THE GII PS HI FLEX ISRT SZ 7-8 13 ((B)(4)) WERE REMOVED FROM THE PATIENT AND REPLACED WITH SMITH AND NEPHEW DEVICES. THERE IS NOT SPECIFIC INFORMATION ABOUT THE NEW IMPLANTS THAT WERE USE IN THE REVISION SURGERY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 11814192 ↗
• InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENT HAD MULTI LIGAMENT RECONSTRUCTION, BONE STAPLES IN BOTH LATERAL TIBIA AND PROXIMAL FEMUR MEDIAL. THESE STAPLES WERE STILL INSIDE AT TIME OF REVISION SURGERY (B)(6) 2020. REVISION SURGERY OF TIBIAL BASE PLATE, INSERT AND PATELLA RESURFACING. THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 10906033 ↗
• InjuryMay 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CLINICAL SUBJECT EXPERIENCED DECREASED RANGE OF MOTION ON THE STUDY KNEE. THE EVENT WAS TREATED VIA SURGERY AND IS CONSIDERED RESOLVED.

  Patient problems: Injury

  MAUDE report 10080671 ↗
• InjuryMay 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CLINICAL SUBJECT EXPERIENCED DECREASED RANGE OF MOTION ON THE STUDY KNEE. THE EVENT WAS TREATED VIA SURGERY AND IS CONSIDERED RESOLVED.

  Patient problems: Injury

  MAUDE report 10080591 ↗
• InjuryJan 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING, OSTEOLYSIS AND POSSIBLE CHANCE OF INFECTION. OSTEOLYSIS WAS CONFIRMED INTRAOPERATORY BY THE SURGEON. ALL COMPONENTS WERE REPLACED WITH CEMENT SPACERS. PRIMARY SURGERY PERFORMED ON (B)(6) 2012.

  Patient problems: Injury

  MAUDE report 9603195 ↗
• InjurySep 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD IMPINGING SCAR TISSUE AND EFFUSION WITH SOME SYNOVITIS. IT WAS RESOLVED THROUGH AN ARTHROSCOPY OF LEFT KNEE REPLACEMENT WITH DEBRIDEMENT OF A SYNOVIAL FOLD AND SCAR TISSUE IN THE MEDIAL GUTTER.

  Patient problems: Injury

  MAUDE report 9056909 ↗
• InjuryAug 28, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING AND POSSIBLE INFECTION.

  Patient problems: Injury

  MAUDE report 8940114 ↗
• InjuryFeb 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A REVISION SURGERY WAS PERFORMED DUE TO TIBIAL COMPONENT MAL-ALIGNED CAUSING PAIN. SURGEON REMOVED A SIZE 7 LEFT TIBIAL BASEPLATE AND SIZE 7-8 13MM PSHF INSERT. SURGEON IMPLANTED A SIZE 7-8 LEGION REVISION TIBIAL BASEPLATE WITH 2 EACH 5MM TIBIAL STEP WEDGES AND A SIZE 7-8 15MM PSHF INSERT.

  Patient problems: Injury; Pain

  MAUDE report 8334169 ↗
• InjuryOct 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE THE IMPLANTS ON THE PATIENT DUE TO INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7974731 ↗
• InjuryJan 29, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  TIBIAL LOOSENING, THE OLD TIBIA WAS COMPLETELY LOOSE AND REMOVED. A QUADS TENDON SNIP WAS PERFORMED FOR BETTER ACCESS. SURGEON CHOSE TO USE A 22 LONG TIBIAL CONE. HE ALSO CEMENTED A 120MM STEM IN WITH A SIZE 6 TIBIA AND 18MM INSERT.

  Patient problems: Joint Dislocation

  MAUDE report 7224080 ↗

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