GENESIS II 71420188Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 03596010206367), received between Apr 27, 2018 and Apr 2, 2025 — classified as 30 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 32 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2025Degraded; Biocompatibility; Degraded; Biocompatibility

  IT WAS REPORTED THAT, AFTER PRIMARY TKA SURGERY HAD BEEN PERFORMED IN 2010, THE PATIENT EXPERIENCED KNEE PAIN. THE X-RAYS CONFIRMED AN ISSUE WITH THE PATIENT'S KNEE. THE SURGEON DISCOVERED THAT THE OXONIUM SURFACE ON THE LATERAL SIDE OF THE FEMUR, HAD WORN OFF DUE TO METAL-ON-METAL WEAR. THE POLY INSERT WAS VERY WORN ON THE LATERAL SIDE, CONFIRMING THE METAL-ON-METAL ISSUE. THIS ADVERSE EVENT WAS SOLVED BY TKA REVISION SURGERY ON (B)(6)2025, IN WHICH THE KNEE WAS WASHED OUT, AND ONE (1) GNS II CMT TIB SIZE 6 RIGHT, PLUS THE OTHER COMPONENTS, WERE REVISED. THE PATIENT LEFT THE REVISION SURGERY IN GOOD HEALTH. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Implant Pain; Metal Related Pathology; Radiolucent Lines

  MAUDE report 21751393 ↗
• InjuryAug 14, 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 IN (B)(6) 2023, THE PATIENT EXPERIENCED RESTRICTED RANGE OF MOTION. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A MUA AND ARTHROSCOPIC "SYNOVECTOMY" TO INCREASE RANGE OF MOTION. DOCTOR ALSO MENTIONED THAT THE PATIENT DEVELOPED SIGNIFICANT SCAR TISSUE, WHICH IMPACTED HIS RANGE OF MOTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH GNS II CMT TIB SIZE 6 RIGHT, GNS II RESURF PAT 35MM AND LGN CR HIGH FLEX XLPE SZ 5-6 9MM WERE REVISED, THE DOCTOR INCREASED THE RESECTION AND PUT THE IMPLANT IN LOOSE IN ANTICIPATION THE SIGNIFICANT SCARE TISSUE WILL TIGHTEN THE KNEE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 19982775 ↗
• InjuryJul 2, 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 UNKNOWN DATE, THE PATIENT EXPERIENCED INFECTION OF THE IMPLANTS. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE GNS II CMT TIB SIZE 6 RIGHT AND THE LGN PS HIGH FLEX XLPE SZ 5-6 9MM WERE REMOVED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Medical device site infection

  MAUDE report 19656742 ↗
• InjuryDec 10, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SYSTEM HAD BEEN IMPLANTED ON (B)(6) 2015 WITH A GENESIS II SYSTEM, THE PATIENT STARTED EXPERIENCING SYMPTOMS IN THE MIDDLE OF 2016, WHICH INCREASED OVER TIME. ON (B)(6) 2020, LOOSENING OF FEMORAL AND TIBIAL COMPONENTS WAS DIAGNOSED VIA X-RAYS. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2020 TO CONVERT FROM THE PS GENESIS II CONSTRUCT TO A LEGION HK SYSTEM. PATIENT WAS DISCHARGED WITH REHAB.

  Patient problems: Deformity/ Disfigurement; Inadequate Osseointegration

  MAUDE report 18298546 ↗
• InjurySep 20, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED PAIN AND JOINT EFFUSION. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY FOR LOOSENING ON (B)(6) 2023, IN WHICH IT WAS NOTICED THAT THERE WAS A COMPLETE DE-BONDING OF THE GNS II CMT TIB SIZE 6 RIGHT FROM THE CEMENT MANTLE, NO INFECTION SUSPECTED/INDICATED. THE GNS II CMT TIB SIZE 6 RIGHT WAS EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS RECOVERING FROM REVISION TKA.

  Patient problems: Joint effusion; Pain

  MAUDE report 17780578 ↗
• InjuryMar 4, 2023Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT, AFTER TKR SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, PATIENT EXPERIENCED LOOSE TIBIA AND INSTABILITY. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH GNS II CMT TIB SIZE 6 RIGHT AND INSERT 5/6 9MM WERE REMOVED AND REPLACED WITH SMITH & NEPHEW BACK-UP DEVICES (POROUS LEGION SIZE 6 TIBIA AND 15MM CR DISHED INSERT). PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 16483393 ↗
• MalfunctionAug 17, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING THE SET UP FOR A TKA SURGERY, IT WAS NOTICED THAT THE INNER PACKAGE OF THE GGENESIS II NON-POROUS TIBIAL BASEPLATE SIZE 6 RIGHT WAS UNSEALED. SURGERY WAS PERFORMED WITH A BACK-UP DEVICE INSTEAD. IT IS UNKNOWN IF THIS CAUSED ANY DELAY TO THE PROCEDURE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15241910 ↗
• MalfunctionAug 11, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  (B)(6) REF#: (B)(4). IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN THE CUSTOMER OPENED THE PACKAGE, IT WAS FOUND THAT STEM OF THE BASEPLATE PUNCTURED INNER POUCH. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING A SMITH AND NEPHEW BACK-UP DEVICE. NO HEALTH CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12307605 ↗
• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT TKA WITH GII CONSTRUCTS WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED STIFFNESS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EFFECT. THE GII OXIN P/S FEM RIGHT SZ 7 (CASE: (B)(4)), THE GNS II CMT TIB SIZE 6 RIGHT (CASE: (B)(4)), AND THE GII PS INSERT SZ 5-6 9MM (CASE: (B)(4)) WERE EXPLANTED. IT IS UNKNOWN WHAT NEW DEVICES WERE IMPLANTED TO THE PATIENT. NO OTHER COMPLICATIONS WERE REPORTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Loss of Range of Motion

  MAUDE report 11821342 ↗
• 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: Osteolysis; Unspecified Infection

  MAUDE report 11042027 ↗
• 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 10261765 ↗
• InjuryJul 2, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT A REVISION SURGERY HAD TO BE PERFORMED DUE TO TIBIAL LOOSENING. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10224210 ↗
• InjuryApr 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT HAD A BILATERAL TKR PERFORMED. RECENTLY PATIENT PRESENTED WITH PAIN AND INFECTION ON HIS RIGHT SIDE TKR. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO CORRECT THE ISSUE. ALL THE IMPLANTS WERE REMOVED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9991993 ↗
• InjuryApr 4, 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 INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9926197 ↗
• InjuryMar 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED DUE TO THE PROGRESSION OF PATELLO FEMORAL OSTEOARTHRITIS AS A TREATMENT.

  Patient problems: Injury

  MAUDE report 9880407 ↗
• InjuryMar 19, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT PATIENT UNDERWENT A BONE SCAN AND THE SURGEON REPORTED THAT THE REVISION BASEPLATE WAS LOOSE. THERE IS NOT CONFIRMATION ANY MEDICAL INTERVENTION DUE TO THIS PROBLEM.

  Patient problems: Injury

  MAUDE report 9853935 ↗
• InjuryOct 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SECOND REVISION SURGERY WAS PERFORMED DUE TO PAIN AND SWELLING. NO INFECTION. ALL IMPLANTS WERE REMOVED EXCEPT THE PATELLA. SURGEON DOES NOT BLAME THE IMPLANT.

  Patient problems: Pain

  MAUDE report 9187421 ↗
• InjurySep 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Unspecified Infection

  MAUDE report 8967567 ↗
• InjuryAug 26, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT WAS NOTED WITH STIFFNESS POST RIGHT TKR FOR WHICH MANIPULATION UNDER ANESTHESIA WAS REQUIRED.

  Patient problems: Injury

  MAUDE report 8931568 ↗
• InjuryMay 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT YEARS AFTER TKA THE PATIENT EXPERIENCED A PULMONARY EMBOLISM. ADVERSE EVENT IS CONSIDERED TO BE DEFINITELY RELATED TO THE RIGHT KNEE PROCEDURE.

  Patient problems: Pulmonary Embolism

  MAUDE report 8624325 ↗
• InjuryApr 24, 2019Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FLEXION INSTABILITY AND TIGHTNESS LATERALLY. TIBIA, PATELLA, INSERT, FEMORAL WERE EXPLANTED AND REPLACED WITH COMPETITORS DEVICES.

  Patient problems: Injury

  MAUDE report 8547332 ↗
• InjuryDec 12, 2018Adverse 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 RIGHT KNEE INSTABILITY STATUS POST TOTAL KNEE REPLACEMENT. TIBIAL COMPONENT, TIBIAL BASEPLATE AND POLY INSERT WERE REMOVED.

  Patient problems: Injury

  MAUDE report 8156756 ↗
• InjuryDec 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS DIAGNOSED WITH RIGHT KNEE STIFFNESS STATUS POST REVISION, AND RIGHT KNEE REPLACEMENT. A MANIPULATION UNDER ANESTHESIA AND AN INJECTION OF PAIN COCKTAIL CONTAINING TORADOL, MORPHINE, EPINEPHRINE AND BUPIVACAINE, IN PERIARTICULAR TISSUES AND INTRA-ARTICULARLY WERE PERFORMED.

  Patient problems: Injury; Neck Stiffness

  MAUDE report 8155611 ↗
• InjuryDec 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED TO PATIENT.

  Patient problems: Injury; Pain

  MAUDE report 8155126 ↗
• InjuryDec 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO WAS MORE THAN THREE MONTHS STATUS POST HER SURGERY, FAILED TO REGAIN FULL RANGE OF MOTION ON HER RIGHT KNEE. A MANIPULATION UNDER ANESTHESIA WAS PERFORMED AND AN INJECTION FOR PAIN CONTROL POSTOPERATIVELY WAS APPLIED ON HER RIGHT KNEE.

  Patient problems: Injury; Loss of Range of Motion

  MAUDE report 8154961 ↗

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