GENESIS II 71420190Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 03596010206374), received between Jun 27, 2017 and Feb 9, 2026 — classified as 34 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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 35 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED IN EARLY 2022, THE PATIENT TRIPPED OVER THEIR DOG TWICE IN (B)(6) 2025 AND FELL ON THEIR RIGHT KNEE, CAUSING SWELLING. THE PATIENT HAD A POST-TRAUMATIC ASEPTIC LOOSENING. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH ONE (1) GNS II NON-POR TIB SZ 7 RIGHT AND ONE (1) LGN PS HIGH FLEX XLPE SZ 7-8 9MM WERE REPLACED WITH A LEGION REVISION TIBIAL BASEPLATE AND STEM. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Aseptic loosening; Fall; Swelling/ Edema

  MAUDE report 24293393 ↗
• InjuryDec 2, 2025Loosening of Implant Not Related to Bone-Ingrowth; Implant subsidence; Loosening of Implant Not Related to Bone-Ingrowth; Implant subsidence

  IT WAS REPORTED THAT, AFTER TKR SURGERY HAD BEEN PERFORMED MORE THAN 10 YEARS AGO, THE PATIENT EXPERIENCED LOOSENING AND SUBSIDENCE OF THE TIBIAL BASE PLATE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH A GNS II NON-POR TIB SZ 7 RIGHT WAS REVISED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Aseptic loosening

  MAUDE report 23700964 ↗
• InjuryAug 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2025, PATIENT EXPERIENCED A BREAKAGE. THE METAL COMPONENT WAS DISCOVERED BROKEN AT THE ANTERIOR ASPECT OF THE TKA TIBIAL TRAY WITH POLY INSTABILITY AND LOCKING FAILURE. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY, DURING WHICH, THE GNS II NON-POR TIB SZ 7 RIGHT AND LGN PS HIGH FLEX XLPE SZ 7-8 9MM WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 22710588 ↗
• InjurySep 5, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA PERFORMED ON AN UNKNOWN DATE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO REVISE REVISED THE GENESIS II COMPONENTS ON THE RIGHT SIDE DUE TO SUSPECTED TIBIAL LOOSENING AND POSSIBLE INFECTION. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 20151757 ↗
• InjuryJun 11, 2024Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED APPROXIMATELY A YEAR AGO, A SUBLUXED POLYETHYLENE LINER WAS DISCOVERED. A REVISION SURGERY WAS PERFORMED ON AN UNKNOWN DATE TO ADDRESS THIS ADVERSE EVENT. A NEW POLYETHYLENE LINER WAS INSERTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 19510640 ↗
• MalfunctionMay 22, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SET UP FOR A TKA, ONE (1) GNS II NON-POR TIB SZ 7 RIGHT WAS NOTICED THAT IT HAD COME WITH THE INNER PACKAGING POTENTIALLY DAMAGED. AS THIS WAS NOTICED UPON SET UP OR INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19376956 ↗
• InjuryJan 5, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED 9 YEARS AGO, THE PATIENT EXPERIENCED ANTERIOR TIBIAL PAIN IN THE LAST 4 MONTH. A BONE SCAN INDICATED GNS II NON-POR TIB SZ 7 RIGHT LOOSENING. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2023 WHERE THE TIBIAL BASEPLATE WAS EXCHANGED. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18454989 ↗
• InjuryApr 3, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, HAD BEEN PERFORMED, THE PATIENT EXPERIENCED IMPLANT LOOSENING. THIS ADVERSE EVENT WAS SOLVED THROUGH A REVISION SURGERY PERFORMED ON (B)(6) 2023 IN WHICH THE TIBIAL BASE PLATE WAS EXPLANTED AND REPLACED. THE TIBIAL COMPONENT HAD NO CEMENT ON THE UNDERSIDE, THE CEMENT WAS WELL BONDED TO THE BONE. PATIENT STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 16663743 ↗
• InjuryOct 18, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2019, THE PATIENT EXPERIENCED PAIN AND THE BIA WAS LOOSE. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2022. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Arthralgia; Inadequate Osseointegration; Joint Laxity; Pain

  MAUDE report 15626637 ↗
• InjuryFeb 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED ON (B)(6) 2016, THE PATIENT EXPERIENCED LOOSENESS IN PATELLA AND PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022, IN WHICH , GNS II NON-POR TIB SZ 7 RIGHT WAS EXPLANTED AND REPLACED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Pain

  MAUDE report 13416201 ↗
• InjuryDec 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A KNEE REPLACEMENT ON (B)(6) 2021, REVISION SURGERY WAS PERFORMED ON THE RIGHT SIDE TO REPLACED THE GNS II NON-POR TIB SZ 7 RIGHT (CASE-(B)(4)) AND THE LGN PS HIGH FLEX XLPE SZ 7-8 9MM (CASE-(B)(4)) ON (B)(6) 2021 DUE TO INSTABILITY. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 12983529 ↗
• InjuryAug 19, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TOTAL KNEE ARTHROPLASTY (CONDUCTED ON AN UNKNOWN DATE), A GENESIS II NON-POROUS TIBIAL SIZE 7 RIGHT AND A LEGION POSTERIOR STABILIZED HIGH FLEX HIGHLY CROSS LINKED POLYETHYLENE SIZE 7-8 9MM WERE SUSPECTED OF LOOSENING. THE ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12343622 ↗
• InjuryJul 5, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA, A REVISION SURGERY OF A GENESIS II TKR WAS PERFORMED ON (B)(6) 2021 DUE TO ASEPTIC LOOSENING. BOTH TIBIAL AND PATELLA COMPONENTS WERE LOOSE. BOTH IMPLANTS HAD FAILED AT THE CEMENT/IMPLANT INTERFACE. THERE WAS NO CEMENT AT ALL STILL ATTACHED TO THE TIBIAL COMPONENT. THERE WERE NO OBVIOUS SIGNS OF ABNORMAL WEAR PATTERNS AND THE KNEE LOOKED WELL ALIGNED IN IMAGING POST PRIMARY TKR. THE LGN PS HIGH FLEX XLPE SZ 7-8 9MM ((B)(4)), GNS II RESURF PAT 32MM ((B)(4)) AND GNS II NON-POR TIB SZ 7 RIGHT ((B)(4)) WERE EXPLANTED. THE CURRENT HEALTH STATUS OF PATIENT AND THE INITIAL SURGERY DATE IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12119180 ↗
• InjuryMar 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PATIENT SHOWED SIGNS OF ASEPTIC LOOSENING OF HIS TIBIAL COMPONENT POST TKR. TIBIAL AND PATELLA COMPONENTS WERE REMOVED.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11396671 ↗
• InjuryFeb 15, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED, IT HAS BEEN MADE A REVISION SURGERY DUE TO TIBIAL LOOSENING. THE LGN PS HIGH FLEX XLPE SZ 7-8 11MM, GNS II NON-POR TIB SZ 7 RIGHT AND LEGION PS OXIN FEM SZ7 RT WERE EXPLANTED. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 11326538 ↗
• InjuryFeb 12, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT HAD A TKA IN 2016. PATIENT PRESENTED ASEPTIC LOOSENING OF THE TIBIAL BASEPLATE. THE TIBIAL BASEPLATE WAS REMOVED AND REVISED TO A REVISION BASEPLATE WITH STEM AND TIBIAL CONE. THE GNS II NON-POR TIB SZ 7 RIGHT AND LGN PS HIGH FLEX XLPE SZ 7-8 9MM WERE EXPLANTED. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 11325683 ↗
• InjuryDec 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY OF GENESSIS II WAS PERFORMED DUE TO INFECTION. NO S&N PRODUCTS WERE IMPLANTED.

  Patient problems: Injury

  MAUDE report 9451179 ↗
• InjuryDec 10, 2019Adverse 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 A KNEE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9443914 ↗
• InjuryNov 15, 2019Unstable; Unstable

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY. ALL PRIMARY IMPLANTS REMOVED EXCEPT FOR PATELLA. PATELLA LEFT IN SITU. NO MORE INFORMATION AVAILABLE.

  Patient problems: Injury

  MAUDE report 9328341 ↗
• InjuryAug 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Unspecified Infection

  MAUDE report 8931586 ↗
• InjuryJul 15, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2012 A TKA PROCEDURE WAS PERFORMED. PATIENT EXPERIENCE POST-OPERATIVE STIFFNESS AND A MUA WAS PERFORMED TO CORRECT THE ISSUE. SLOWLY STIFFNESS RETURNED AND A REVISION SURGERY WAS REQUIRED TO INCREASE ROM MAINLY INTO FLEXIBILITY. SURGEON ATTRIBUTED STIFFNESS TO SCARRING AND PATELLA MALTRACKING. A SCAR WAS PERFORMED TO RELEASE, POLY EXCHANGE AND REVISED PATELLA. ROM IMPROVED POST-OPERATIVE.

  Patient problems: Injury

  MAUDE report 8787745 ↗
• InjuryJun 24, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING OF FEMORAL COMPONENT, PATELLA AND TIBIAL BASEPLATE.

  Patient problems: Injury

  MAUDE report 8727646 ↗
• InjuryJun 3, 2019Fracture; Fracture

  IT WAS REPORTED THAT PATIENT HAS A TIBIAL FRACTURE AND AN INFECTION WAS ALSO CONFIRMED. THEREFORE A REVISION SURGERY WAS PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 8663097 ↗
• InjuryFeb 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A FLUOROSCOPICALLY GUIDED RIGHT TKA ASPIRATION WAS PERFORMED DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 8350703 ↗
• InjuryFeb 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A REVISION SURGERY PERFORMED DUE TO CONSISTENT PAIN.

  Patient problems: Injury; Pain

  MAUDE report 8349581 ↗

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-0131-2014 · Oct 7, 2013 · Terminated
  GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic
• Z-0130-2014 · Oct 7, 2013 · Terminated
  GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic