GENESIS II 71420170Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 03596010206282), received between May 14, 2018 and Jul 9, 2025 — classified as 24 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 26 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 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) 2022, THE PATIENT EXPERIENCED TIBIAL COMPONENT SUBSIDENCE AND AN OVERSIZED FEMORAL COMPONENT. THE TIBIAL IMPLANT WAS LOOSE, AND THE FEMORAL IMPLANT WAS MISALIGNED. THIS ADVERSE EVENT WAS SOLVED BY REMOVING AND REPLACING THE TIBIAL, FEMORAL, AND POLYETHYLENE COMPONENTS. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Deformity/ Disfigurement; Inadequate Osseointegration

  MAUDE report 22465575 ↗
• InjuryMay 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A LEFT TKA WAS PERFORMED, AND THE PATIENT DEVELOPED INCESSANT PAIN FOR ONE YEAR UNTIL THEIR POST-OPERATIVE CHECKUP ON (B)(6) 2023. AFTER THE PROCEDURE, THE PATIENT UNDERWENT THE PRESCRIBED SIX WEEKS OF THREE TIMES A WEEK PHYSICAL THERAPY PLUS AN ADDITIONAL CONTINUATION OF PHYSICAL THERAPY ON (B)(6). X-RAYS WERE TAKEN DURING THE POST OP CHECK UP ON (B)(6) 2023 AND REVEALED THE SEPARATION OF THE INSERT AND THE TIBIAL COMPONENT, SO THE PATIENT WAS TOLD A REVISION WOULD BE NECESSARY. THE STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Inadequate Osseointegration; Joint Dislocation; Pain

  MAUDE report 16883090 ↗
• 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) 2015 WITH OSTEOARTHRITIS AS PRIMARY DIAGNOSIS, THE PATIENT REQUIRED A REVISION SURGERY ON (B)(6) 2019 DUE TO THE FOLLOWING DIAGNOSIS/COMPLICATION(S): ASEPTIC LOOSENING OF THE TIBIAL COMPONENT AND IMPLANT FRACTURE. DURING THIS PROCEDURE, ALL THE KNEE PROSTHESIS COMPONENTS WERE EXPLANTED AND REPLACED WITH A COMPETITORS KNEE REVISION SYSTEM. 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 OXINIUM 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

  MAUDE report 16396136 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKJR SURGERY HAD BEEN PERFORMED ON (B)(6) 2012, THE PATIENT REPORTED SUFFERING FROM MAJOR KNEE EFFUSION, LYSIS, POOR ROM AND PAIN. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON (B)(6) 2021 TO REPLACE THE TIBIAL BASEPLATE, FEMORAL COMPONENT AND THE INSERT. ADDITIONALLY WAS OBSERVED THAT THERE WAS NO CEMENT ON THE BACK OF THE IMPLANT, INDICATING THAT THE PRODUCT HAD FAILED HAD THE CEMENT/IMPLANT INTERFACE. THE PATIENT IS ON EARLY STAGE OF RECOVERY.

  Patient problems: Failure of Implant; Laceration(s); Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 13022487 ↗
• 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; Unspecified Infection

  MAUDE report 11845709 ↗
• InjuryJan 27, 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 DUE TO PATIENT EXPERIENCING TIBIAL PAIN AND TIBIAL BASE PLATE LOOSENING FOLLOWING A PRIMARY TOTAL KNEE REPLACEMENT. THE GNS II CMT TIB SIZE 6 LEFT AND THE LGN PS HIGH FLEX XLPE SZ 5-6 13MM WERE EXPLANTED. THE PROCEDURE WAS COMPLETED WITH SMITH AND NEPHEW DEVICES. IT IS UNKNOWN IF THERE WAS A DELAY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 11240715 ↗
• MalfunctionJan 26, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION, AFTER CHECKING THE LID OF THE PACKAGE, IT WAS FOUND TO HAVE A HOLE IN IT. THE SURGEON DECIDED NOT TO KEEP THE IMPLANT. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED AND IF THERE WAS A SURGICAL DELAY. NO OTHER COMPLICATIONS WHERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11229599 ↗
• InjuryDec 16, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, A REVISION OF A GEN 2 TIBIA FROM APPROXIMATELY 2010 WAS PERFORMED. THE TIBIA INSERT WAS LOOSE AND REMOVED WITH FINGERS AND REVISED TO A LEGION REVISION TIBIA WITH STEM. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Joint Laxity

  MAUDE report 11023499 ↗
• InjuryDec 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA A REVISION SURGERY WAS PERFORMED DUE TO UNKNOWN REASONS, THE GEN II PS (CASE (B)(4)), GEN II BASEPLATE (CASE (B)(4)) AND PS INSERT (CASE-(B)(4)) WERE EXPLANTED. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11016056 ↗
• InjurySep 21, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED, THE PATIENT HAD AN UNSTABLE KNEE, WITH PAIN AND CLUNKING NOISE. A TOTAL REVISION SURGERY WAS PERFORMED TO EXPLANT ALL COMPONENTS. THE EVENT IS STILL ONGOING.

  Patient problems: Injury; Joint Laxity; Pain

  MAUDE report 10564422 ↗
• InjuryJul 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON DID A KNEE REPLACEMENT WITH S&N IMPLANTS FOR HIS PATIENT ON (B)(6). THE PATIENT PRESENTED CASUALTY TWO WEEKS TIME OF PAIN AND A SWOLLEN KNEE. THE SURGEON DID AN ARTHROSCOPIC WASHOUT INITIALLY, AND THEN TODAY (B)(6) 2020 AS AN ONGOING PROBLEM DID AN OPEN PROCEDURE (REVISION SURGERY) TO WASHOUT AND DEBRIDE THE KNEE AND REPLACE THE TIBIAL INSERT. THERE WAS NO INJURY REPORTED ADN THERE WAS A DELAY BELOW 30 MINUTES. A S&N BACKUP WAS USED.

  Patient problems: Injury

  MAUDE report 10312930 ↗
• 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 10237698 ↗
• InjuryOct 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO A DEEP VEIN THROMBOSIS. THE EVENT WAS RESOLVED VIA MEDICATION.

  Patient problems: Injury

  MAUDE report 9253234 ↗
• 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 9253232 ↗
• MalfunctionAug 22, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO POLY DISENGAGE. ALSO IT WAS NOTED THAT THERE WAS MINIMAL SCRATCHING ON THE FEMUR, AND THE LOCKING MECHANISM ON THE TIBIA WAS DAMAGED, THEREFORE, SURGEON DECIDED TO MOVE AHEAD WITH FULL REVISION SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8920511 ↗
• InjuryMar 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENT AND METALLOSIS WAS FOUND AS THE CAUSE OF PAIN. NO INFECTION PRESENT. TWO DEVICES REPORTED. NO ADDITIONAL DETAILS AVAILABLE.

  Patient problems: Pain

  MAUDE report 8448744 ↗
• InjuryNov 19, 2018Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED FOR A BROKEN POSTERIOR TIBIA PLATEAU. NO DELAY, ADDITIONAL INJURIES OR BACK UP REPORTED.

  Patient problems: Injury

  MAUDE report 8083882 ↗
• InjuryNov 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD AN INJECTION IN PES ANSERINE BURSA TO RELIEF PERSISTENT PAIN. ALSO CLICKING AND POPPING FELT BY DOCTOR THAT MAY BE RELATED TO CAPSULAR FIBROSIS.

  Patient problems: Pain

  MAUDE report 8036209 ↗
• InjuryNov 2, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT PATIENT HAD A TKA ON (B)(6) 2018 AND HAD A DISLOCATION OF THE POLY DUE TO A FALL ON AN UNSPECIFIED DATE. REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 TO EXCHANGE THE POLY. DOCTOR (B)(6) NOTICED THAT THE POLY HAD SLIGHT MOVEMENT ON THE ANTERIOR FLANGE AND WAS CONCERNED THERE WAS DAMAGE TO THE LOCKING MECHANISM OF THE BASE PLATE, DOCTOR REQUESTED A NEW BASE PLATE AND ANOTHER NEW POLY TO BE OPENED TO COMPARE THE ANTERIOR MOVEMENT OF A BRAND NEW POLY AND BASE PLATE COMPARED TO THE OLD BASE PLATE WITH THE NEW POLY. DOCTOR WAS SATISFIED THAT THE POLY WAS SECURE ENOUGH AND CLOSED THE UP WITH THE OLD BASE PLATE STILL INSTU WITH A NEW POLY.

  Patient problems: Joint Dislocation

  MAUDE report 8034068 ↗
• InjuryNov 1, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT PATIENT HAD A REVISION SURGERY PERFORMED DUE TO PAIN, LOOSENING OF TIBIAL COMPONENT, MALALIGNMENT AND PATELLAR CLUNK SYNDROME.

  Patient problems: Injury; Pain

  MAUDE report 8028813 ↗
• InjuryOct 25, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED. PATIENT PRESENTED WITH PAIN AND INSTABILITY. X-RAYS REVEALED THAT COMPONENT WAS LOOSE.

  Patient problems: Injury

  MAUDE report 8005275 ↗
• InjuryOct 3, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A MEDICAL INTERVENTION IN WHICH IT WAS REQUIRED TO ASPIRATE THE LEFT KNEE TO PREVENT INFECTION IN THE PERIPROSTHETIC AREA.

  Patient problems: No Code Available

  MAUDE report 7930808 ↗
• InjuryOct 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A MEDICAL INTERVENTION IN WHICH IT WAS REQUIRED TO ASPIRATE THE LEFT KNEE TO PREVENT INFECTION IN THE PERIPROSTHETIC AREA.

  Patient problems: Aspiration/Inhalation; Injury

  MAUDE report 7924874 ↗
• InjuryOct 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED IN WHICH ALL IMPLANTS WERE REMOVED DUE TO PERIPROSTHETIC INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7924249 ↗
• InjuryOct 1, 2018Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO STIFFNESS.

  Patient problems: No Information

  MAUDE report 7924075 ↗

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