GENESIS II 71420576Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 03596010208309), received between Mar 31, 2017 and Jul 20, 2025 — classified as 72 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (35 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 72 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2025Adverse 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) 2019, IS SUSPECTED THE PATIENT EXPERIENCED A FALL/TRAUMA. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) GNS II RESURF PAT 32MM WAS EXCHANGED FOR ONE (1) GNS II RESURF PAT 35MM. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Fall; Periprosthetic fracture

  MAUDE report 22552290 ↗
• InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED, THE PATIENT WAS NOT FULLY SATISFIED FULL TKR. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH A GNS II RESURF PAT 32MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22465416 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED IN AN UNKNOWN DATE, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2025 DUE TO AN UNSPECIFIED REASON. ONE (1) GNS II RESURF PAT 32MM WAS EXCHANGED FOR ONE (1) GNS II RESURF PAT 35MM. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22292702 ↗
• InjuryApr 23, 2025Loosening 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) 2021, THE PATIENT EXPERIENCED ANTERIOR KNEE PAIN. PATIENT IS REPORTEDLY RHEUMATOID. THE PAIN WAS ADDRESSED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) GNS II RESURF PAT 32MM WAS NOTED TO BE LOOSE, AND IT WAS EASILY REMOVED. ANOTHER 32MM RESURFACING PATELLA WAS PLACED INSTEAD. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF THE PATIENT.

  Patient problems: Pain

  MAUDE report 21896428 ↗
• InjuryJun 13, 2024Adverse 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 AN AVULSION OF THE PROXIMAL POLE OF THE PATELLA WITH MINIMAL TO NO KNEE PAIN. THE ONSET OF THE SYMPTOMS WAS ON (B)(6) 2023. NO ACTIONS HAVE BEEN TAKEN TO SOLVE THIS ADVERSE EVENT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bone Fracture(s); Discomfort

  MAUDE report 19528992 ↗
• InjurySep 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT TKA SURGERY HAD BEEN PERFORMED IN 2011, THE PATIENT EXPERIENCED JOINT LAXITY. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6)2023, IN WHICH THE GNS II RESURF PAT 32MM AND THE LGN CR HIGH FLEX XLPE SZ 1-2 11MM WERE REPLACED WITH ANOTHER 32MM RESURFACING PATELLA AND A 13MM CR INSERT, RESPECTIVELY. DURING SURGERY, IT WAS NOTICED THAT THE FEMORAL AND TIBIAL IMPLANTS WERE WELL FIXED AND STABLE, THERE WAS NO DELAMINATION OF THE INSERT AND THERE WAS A SLIGHT LYSIS ON THE PATELLA BUTTON, AND SIGNS OF WEAR. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity; Osteolysis

  MAUDE report 17764305 ↗
• InjuryJun 27, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER PARTIAL KNEE REPLACEMENT WAS PERFORMED ON (B)(6) 2019, THE PATIENT EXPERIENCED PATELLAR COMPONENT LOOSENING. THIS COMPLICATION WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2023, IN WHICH THE IMPLANT WAS REPLACED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 17209812 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT TKR SURGERY HAD BEEN PERFORMED IN 2013, THE PATIENT COMPLAINED OF PATELLAR - FEMORAL PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 IN ORDER TO REMOVE THE GNS II RESURF PAT 32MM DEVICE AND IMPLANT AN OVAL 38MM RESURFACING DEVICE. NO FURTHER INFORMATION AVAILABLE AT THIS MOMENT.

  Patient problems: Pain

  MAUDE report 16547326 ↗
• InjuryApr 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA REVISION SURGERY HAD BEEN PERFORMED ON (B)(6) 2015, THE PATIENT EXPERIENCED PAIN. THE PHYSICIAN MENTIONED THAT THE LGN REV TIBIA BASE SZ 5 LT WAS SHOWING RED ON THE BONE SCAN REPORT AND THAT THE TKR REPLACEMENT WAS MOST LIKELY INFECTED; THEREFORE, AN ANTIBIOTIC SPACER WAS NEEDED. THIS ADVERSE EVENT WAS SOLVED BY A THIRD REVISION SURGERY ON (B)(6) 2022, IN WHICH THE GNS II RESURF PAT 32MM WAS EXPLANTED, AND GII IMPLANTS WERE IMPLANTED WITH ANTIBIOTICS. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Implant Pain; Unspecified Infection

  MAUDE report 13996176 ↗
• InjuryAug 26, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT PATIENT PRESENTED MECHANICAL LOOSENING OF INTERNAL RIGHT KNEE PATELLA BUTTON; A REVISION SURGERY WAS PERFORMED DUE TO THIS EVENT. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12373413 ↗
• InjuryJul 6, 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 (CASE-(B)(4)), GNS II RESURF PAT 32MM (CASE-(B)(4)) AND GNS II NON-POR TIB SZ 7 RIGHT (CASE-(B)(4) WERE EXPLANTED. THE CURRENT HEALTH STATUS OF PATIENT AND THE INITIAL SURGERY DATE IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12125680 ↗
• InjuryMay 21, 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 17 YEARS AGO USING A GNS II CMT TIB SIZE 3 RIGHT, A GNS II RESURF PAT 32MM AND THE GII PS HI FLEX ISRT SZ 3-4 9. THE PATIENT HAD A REVISION SURGERY TO REMOVED AND REPLACED THE IMPLANTS ON AN UNKNOWN DATE. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 11862922 ↗
• InjuryJul 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD REVISION SURGERY FOR AN INFECTION, FOR THAT REASON ALL THE IMPLANTS WERE REMOVED AND IT WAS IMPLANTED A NEW CEMENT MOLD AND A POLY TIBIA. THE SURGEON REPORTS THAT THE IMPLANTS DID NOT INFLUENCE THE DEVELOPMENT OF THE INFECTION. 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 10237706 ↗
• InjuryMay 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  [STUDY: (B)(6); SUBJECT ID: (B)(6); AE#: 2] IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED IN WHICH A JOURNEY II XR SYSTEM WAS IMPLANTED, THE CLINICAL SUBJECT SUFFERED FROM A (B)(6) INFECTION. A REVISION SURGERY WAS PERFORMED TO TREAT THE ADVERSE EVENT. THE EVENT IS RESOLVED.

  Patient problems: Bacterial Infection

  MAUDE report 10096966 ↗
• InjuryMay 26, 2020Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT PRESENTED RIGHT KNEE STIFFNESS POST RIGHT TOTAL KNEE ARTHROPLASTY. EVENT WAS RESOLVED WITH MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury; Limited Mobility Of The Implanted Joint

  MAUDE report 10087844 ↗
• InjuryMay 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, AFTER A PRIMARY TKA SURGERY HAD BEEN PERFORMED WITH A JOURNEY II SYSTEM, THE CLINICAL SUBJECT EXPERIENCED OCCASIONAL SWELLING AND PAIN. THE IMPLANTED TKR SYSTEM FAILED: IT IS BELIEVED THAT TIBIAL LOOSENING WAS IMPLICATED. A REVISION SURGERY WAS PERFORMED TO EXPLANT THE GENESIS II RESURFACED PATELLAR COMPONENT. AN S&N LEGION SYSTEM WAS IMPLANTED INSTEAD. THE EVENT IS CONSIDERED AS RESOLVED.

  Patient problems: Arthralgia; Joint Swelling

  MAUDE report 10027430 ↗
• InjuryApr 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CLINICAL SUBJECT PRESENTED POSTOPERATIVE RIGHT KNEE STIFFNESS. THE EVENT WAS TREATED VIA MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 10015700 ↗
• InjuryMar 30, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM LEFT KNEE STIFFNESS. THE EVENT WAS TREATED VIA MANIPULATION UNDER ANESTHESIA AND IT'S CONSIDERED RESOLVED WITH RESIDUES.

  Patient problems: Injury

  MAUDE report 9901092 ↗
• InjuryMar 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM SCAR TISSUE DEBRIDEMENT ON THE LEFT KNEE. THE EVENT WAS TREATED VIA ARTHROSCOPY AND WAS RESOLVED WITH RESIDUAL EFFECTS.

  Patient problems: Injury

  MAUDE report 9901062 ↗
• InjuryFeb 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN AND INFECTION. THE DOCTOR SAID THAT THE DEVICES DID NOT DEFECT. HE RESOLVED PATELLA LOOSENING DUE TO INFECTION AFTER TKA SURGERY.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9729919 ↗
• InjuryFeb 12, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT PATIENT HAD S&N COMPONENTS SINCE (B)(6) 2012. THE KNEE WAS REVISED FOR LOOSENING DUE TO OSTEOLYSIS AND POSSIBLE INFECTION. ALL COMPONENTS WERE REMOVED TODAY AND REPLACED WITH A CEMENT SPACER AND A LEGION DISHED 5-6 13MM POLY.

  Patient problems: Injury

  MAUDE report 9699676 ↗
• 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 9603237 ↗
• InjuryDec 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATELLA COMPONENT WAS DISASSOCIATED. AN OPEN REDUCTION WAS PERFORMED TO CORRECT THE ISSUE. NO COMPONENTS EXPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9516106 ↗
• InjuryDec 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN AND A FEELING OF UNWILLINGNESS.

  Patient problems: Pain

  MAUDE report 9419223 ↗
• InjuryOct 29, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT WAS TREATED DUE TO LEFT KNEE STIFFNESS. THE EVENT WAS RESOLVED VIA MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 9253253 ↗

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