GENESIS II 71420578Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 03596010208316), received between Jun 14, 2017 and Nov 30, 2025 — classified as 82 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (31 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 25 most recent of 82 reports, in the reporter's own words as published by the FDA.

• InjuryNov 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER RIGHT TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PAIN. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH THE GNS II RESURF PAT 35MM WAS REPLACED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 23677084 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING A TKA SURGERY PERFORMED ON AN UNKNOWN DATE, A REVISION SURGERY WAS REQUIRED ON (B)(6) 2025 FOR ONE (1) GNS II RESURF PAT 35MM AND ONE (1) LGN PS HIGH FLEX XLPE SZ 3-4 9MM, UNDER UNKNOWN CIRCUMSTANCES. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23080791 ↗
• InjuryJun 12, 2025Adverse 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 AN UNKNOWN DATE, THE PATIENT EXPERIENCED A CURRENTLY UNKNOWN ADVERSE EVENT. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE GNS II RESURFACE PAT 35MM WAS EXCHANGED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22194793 ↗
• InjuryApr 16, 2025Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2020, THE PATIENT HAD A MOTORCYCLE ACCIDENT. THE PATELLA'S PEG PART BROKE OFF, CAUSING A FEELING OF DISCOMFORT, AND LOOSENING OF THE PATELLA. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE GNS II RESURF PAT 35MM AND THE JRNY II BCS XLPE ART ISRT SZ 5-6 RT 9MM WERE REPLACED WITH NEW S+N IMPLANTS. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Aseptic loosening; Discomfort

  MAUDE report 21851519 ↗
• InjuryNov 26, 2024Material Deformation; Loosening of Implant Not Related to Bone-Ingrowth; Material Deformation; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED THE GNS II RESURF PAT 35 MM PATELLA COMPONENT HAD LOOSENED FROM THE CEMENT IMPLANT INTERFACE AND THE GII DISHED INS SZ 7-8 9 MM POLY WAS SLIGHTLY DEFORMED ON THE ANTERIOR EDGE, BUT NO SIGNIFICANT SIGNS OF WEAR. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE GII DISHED INS SZ 7-8 9 MM AND THE GNS II RESURF PAT 35 MM WERE EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Aseptic loosening; Failure of Implant

  MAUDE report 20783491 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT WAS EXPERIENCING PAIN. ON INSPECTION OF THE KNEE IT WAS NOTICED THAT THE GNS II RESURF PAT 35MM WAS MALTRACKING AND ON (B)(6) 2024 A REVISION SURGERY WAS PERFORMED TO ADDRESS THIS ISSUE. THE FEMUR AND PATELLA WERE REMOVED AND REPLACED WITH A SIZE 6 LEGION REVISION FEMORAL IMPLANT AND 35MM RESURFACE PATELLA. SURGEON REPORTED THAT THE PATELLA WAS TRACKING AS EXPECTED FOLLOWING THE REVISION.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 20556492 ↗
• InjuryAug 9, 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 GII OVAL RESURFACING PAT 32MM. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2023. CURRENT HEALTH STATUS OF PATIENT REMAINS UNKNOWN.

  Patient problems: Necrosis

  MAUDE report 17495558 ↗
• InjuryOct 4, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A TKA WITH A GENESIS II SYSTEM HAD BEEN PERFORMED, THE PATELLA BUTTON BECAME DISLODGED AND MOVED DOWN BELOW THE KNEE, CAUSING PAIN AND INSTABILITY. A REVISION SURGERY WAS PERFORMED TO ADDRESS THE EVENT.

  Patient problems: Arthralgia; Failure of Implant; Joint Dislocation; Joint Laxity

  MAUDE report 15540498 ↗
• InjuryMay 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKR SURGERY HAD BEEN PERFORMED ON THE (B)(6) 2015, THE PATIENT WAS FELLING PAIN. THE PATIENT UNDERWENT A REVISION SURGERY ON THE 20-APR-2022 WHERE THE GNS II RESURF PAT 35 MM WAS REPLACED WITH A GII OVAL RESURFACING PAT 41 MM. THE PATIENT IS RECOVERING.

  Patient problems: Pain

  MAUDE report 14417359 ↗
• InjuryApr 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA IN 2016 (UNKNOWN DAY AND MONTH) A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO EXPLANT THE IMPLANTS DUE TO PERIPROSTHETIC INFECTION. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 14068222 ↗
• InjuryFeb 1, 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) 2016, THE PATIENT EXPERIENCED LOOSENESS IN PATELLA AND PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022, IN WHICH THE GNS II RESURF PAT 35MM WAS EXPLANTED AND REPLACED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Pain

  MAUDE report 13412992 ↗
• InjuryNov 26, 2021No Apparent Adverse Event; Loosening of Implant Not Related to Bone-Ingrowth; No Apparent Adverse Event; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED SEVERE PAIN ON THE LATERAL SIDE OF HIS KNEE. X-RAYS SHOWED MALPOSITION OF THE PATELLA AND PATELLA TRACKING. INTRA OPERATIVELY, THE PATIENT HAD A SIGNIFICANT HEMARTHROSIS, THE PATELLA BUTTON WAS LOOSE AND THE PHYSICIAN ESTIMATED THAT THE TIBIAL COMPONENT WAS PLACED ABOUT 8MM OF INTERNAL ROTATION. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2021. THE PHYSICIAN REMOVED THE OLD PATELLA BUTTON, CLEANED OFF THE REMAINING CEMENT, CLEARED AWAY ANY SCAR/FIBROTIC TISSUE, DID A LATERAL RELEASE AND REPOSITIONED A NEW PATELLA BUTTON. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Implant Pain; Inadequate Osseointegration; Pain

  MAUDE report 12878930 ↗
• InjurySep 15, 2021Adverse 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 AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT; THE GII OXIN P/S FEM RIGHT SZ 6, GNS II CMT TIB SIZE 5 RIGHT, LGN PS HIGH FLEX XLPE SZ 5-6 11MM AND GNS II RESURF PAT 35MM WERE EXPLANTED. SURGEON STATED THAT THERE APPEARS TO BE NO ISSUE RELATED TO THE IMPLANTS, AS X-RAYS EXAMINATION SHOWED PROPER FIXATION. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Implant Pain; Insufficient Information

  MAUDE report 12474954 ↗
• InjuryJul 9, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT ON (B)(6) 2021 A WASHOUT OF A TKR WAS PERFORMED DUE TO PAIN AND INFLAMMATION, INFECTION WAS NOT CONFIRMED BUT THE PATELLAR BUTTON WAS LOOSENED AND THE POLYETHYLENE WAS ALSO EXPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Inflammation; Pain

  MAUDE report 12145188 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RECON SURGERY HAD BEEN PERFORMED, THE PATIENT REPORTED AN INFECTION. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON (B)(6) 2021 TO REPLACE THE LGN CR HIGH FLEX XLPE SZ 5-6 10MM, GII LNG STEM 10MM X 100MM, GNS II CMT TIB SIZE 6 LEFT, LEGION CR NP FEM SZ 6 LT, AND GNS II RESURF PAT 35MM. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacterial Infection

  MAUDE report 11844787 ↗
• InjuryApr 29, 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 ON (B)(6) 2020, THE PATIENT EXPERIENCED A LIMITED ROM. THE SURGEON SAYS THAT THE DEVICES WERE NOT DEFECTIVE. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON (B)(6) 2021 TO REPLACE THE JRNY II BCS FEMORAL OXIN LT SZ 4 (CASE: (B)(4)), GNS II RESURF PAT 35MM (CASE: (B)(4)) AND THE JRNY II BCS XLPE ART ISRT SZ 3-4 LT 10MM (CASE: (B)(4)). THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Loss of Range of Motion

  MAUDE report 11744223 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REVISION SURGERY FOR A PATELLA COMPONENT FROM A PRIMARY TKR FROM 2015. THE PATELLA HAD BECOME LOOSE AND WAS FREE WITHIN THE JOINT. DAMAGE WAS OBSERVED ON THE ANCHORING PEGS. NO OTHER COMPLICATION WAS REPORTED.

  Patient problems: Joint Laxity

  MAUDE report 11687031 ↗
• InjuryMar 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A BILATERAL TOTAL KNEE REPLACEMENT 13 MONTHS AGO PATIENT COMPLAINED OF ANTERIOR KNEE PAIN AND PATELLA CREPITUS. SURGEON PERFORMED A PATELLA RESURFACING ON THE PATIENT ON BOTH JOINTS. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 11478941 ↗
• InjuryMar 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A BILATERAL TOTAL KNEE REPLACEMENT 13 MONTHS AGO PATIENT COMPLAINED OF ANTERIOR KNEE PAIN AND PATELLA CREPITUS. SURGEON PERFORMED A PATELLA RESURFACING ON THE PATIENT ON BOTH JOINTS. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 11478928 ↗
• InjuryFeb 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THERE WAS A REVISION SURGERY OF GENESIS2 RESURFACING PATELLA 35 MM DUE TO PATIENT EXPERIENCING PAIN. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED AND IF THERE WAS A DELAY. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Pain

  MAUDE report 11256938 ↗
• InjuryJan 10, 2021Break; Migration; Break; Migration

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2014, THE PATIENT PRESENTED RIGHT KNEE PAIN. A RECENT X-RAY EXAMINATION HIGHLIGHTED THAT THE PATELLA HAD DISPLACED AND WAS IN SUPERIOR PATELLA POUCH. A REVISION SURGEON WAS PERFORMED: THE KNEE WAS OPENED VIA PREVIOUS INCISION, PATELLAR WAS REVIEWED AND THERE WAS NOTICED THAT BUTTON HAD SHEARED OFF. THE PATELLA WAS RESURFACED AS PER SURGICAL TECHNIQUE. THE CURRENT STATE OF HEALTH IN PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 11144583 ↗
• InjuryDec 18, 2020Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT, DURING A TKR WASHING, AT THE TIME OF OPENING THE PATIENT, THERE WAS A LARGE AMOUNTS OF PUS PRESENT, SO THE TKR IMPLANTS WERE REMOVED DUE TO INFECTION AND CEMENT SPACER WAS INSERTED. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 11042020 ↗
• InjuryNov 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON PERFORM A WASHOUT AND DEBRIDEMENT AND A POLY INSERT EXCHANGE DUE TO SEPSIS. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Sepsis

  MAUDE report 10911069 ↗
• InjuryJul 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATELLA IMPLANT WAS REPLACED DUE TO PATELLA PAIN (REVISION SURGERY). THE SURGEON DOES NOT BLAME THE IMPLANT. NO X-RAY OR HISTOLOGY STUDIES ARE AVAILABLE. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2015. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury; Pain

  MAUDE report 10342338 ↗
• InjuryJul 11, 2020Adverse 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 UN DIAGNOSED PAIN. IMPLANTS WERE ALL WELL CEMENTED SCAN WAS SHOWING SOME SIGN OF LOOSENING IN THE TIBIA AND PATELLA, HOWEVER INTRAOPERATIVELY EVERYTHING WELL FIXED.

  Patient problems: Injury; Pain

  MAUDE report 10261767 ↗

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