GENESIS II 71420186Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 03596010206350), received between Mar 19, 2018 and Feb 7, 2025 — classified as 37 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 reports).

1 FDA recall record name this device's identifier.

5 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.

Recalls naming this device

1. Jun 27, 2022Terminated

   The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.

   Z-1418-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 7, 2025Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2021, THE PATIENT SUFFERED FROM A GROSS TIBIAL LOOSENING. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 IN ORDER TO EXCHANGE THE GNS II CMT TIB SIZE 5 RIGHT. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF THE PATIENT.

  Patient problems: Aseptic loosening; Failure of Implant

  MAUDE report 21339829 ↗
• InjuryOct 6, 2023Adverse 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 TKA SURGERY WAS PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED INFECTION AND THE RESPONSIBLE DOCTOR SUSPECTS THAT THERE WAS LIKELY LOOSENING AT THE CEMENT/IMPLANT INTERFACE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH A GNS II CMT TIB SIZE 5 RIGHT WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 17886313 ↗
• InjuryAug 31, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED IN 2015, THE PATIENT EXPERIENCED DEPRESSION OF THE TIBIAL BASEPLATE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO ADDRESS THIS ADVERSE EVENT. REVISION OF BASEPLATE WAS DETERMINED AS BEST COURSE OF ACTION USING S+N REVISION SYSTEM WITH STEM AND CONES. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 17664617 ↗
• InjuryMay 29, 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 (B)(6) 2022, THE PATIENT EXPERIENCED LACK OF RANGE OF MOTION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH THE LGN PS HIGH FLEX XLPE SZ 5-6 9MM AND THE GNS II CMT TIB SIZE 5 RIGHT WERE REPLACED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Loss of Range of Motion

  MAUDE report 14539065 ↗
• MalfunctionMay 20, 2022Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT A BOX OF A GENESIS II NON-POROUS TIBIAL BASEPLATE SIZE 5 RIGHT CONTAINED AN GENESIS II NON-POROUS TIBIAL BASEPLATE SIZE 4 LEFT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14462684 ↗
• InjuryMay 9, 2022Improper or Incorrect Procedure or Method; Manufacturing, Packaging or Shipping Problem; Packaging Problem; Inaccurate Information; Improper or Incorrect Procedure or Method; Manufacturing, Packaging or Shipping Problem; Packaging Problem; Inaccurate Information

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THERE WAS A MISLABEL ISSUE WITH THE GNS II CMT TIB SIZE 5 RIGHT. PERSONAL DID NOT NOTICE THE ERROR UNTIL THEY COULD NOT GET INSERT THE DEVICE IN THE FINAL IMPLANT. THE OUTER BOX AND STICKERS SAID THAT THE DEVICE WAS A GNS II CMT TIB SIZE 5 RIGHT; HOWEVER, THE IMPLANT AND THE INNER PACKING SAID IT WAS A GNS II CMT TIB SIZE 4 LEFT. SURGEON ENDED UP KEEPING THE GNS II CMT TIB SIZE 4 LEFT IN AND USED A 3/4 BY 11 INSERT. THE PROCEDURE WAS COMPLETED, WITH A DELAY LESS THAN 30 MIN, USING THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14342727 ↗
• InjuryApr 28, 2022Adverse 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, THE IMPLANTS WERE REMOVED DUE TO SUSPECTED INFECTION. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2022 TO EXCHANGE THE GNS II CMT TIB SIZE 5 RIGHT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 14246808 ↗
• InjuryApr 25, 2022Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem; Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, A BOX OF GENESIS II NON-POROUS TIBIAL BASEPLATE SIZE 5 RIGHT CONTAINED A SIZE 4 LEFT DEVICE INSTEAD. THE OUTSIDE OF THE BOX DISPLAYED PART NO. 71420186 AND LOT NO. 20CM03707, BUT THE PRODUCT INSIDE WAS A 71420166 FROM LOT NO. 21FM13870. THE INCORRECT DEVICE COULD BE REMOVED BEFORE CEMENTING HARDENED OR DAMAGE OCCURRED. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14192046 ↗
• InjuryMar 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED JOINT INFECTION. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY ON (B)(6) 2022 TO EXCHANGE THE GNS II CMT TIB SIZE 5 RIGHT, THE INSERT AND THE FEMORAL COMPONENT. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 13720461 ↗
• InjuryFeb 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A SURGERY PERFORMED ON (B)(6) 2012, THE PATIENT EXPERIENCED PAIN, THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2022 TO REMOVE THE IMPLANT. FURTHER INFORMATION IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 13615113 ↗
• 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 12474888 ↗
• InjuryAug 30, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, AFTER A TKJR SURGERY HAD BEEN PERFORMED ON (B)(6) 2012, THE PATIENT X-RAY SHOWED THAT THE GNS II CMT TIB SIZE 5 RIGHT IS WORN. WHEN THE GNS II CMT TIB SIZE 5 RIGHT WAS REMOVED, THERE WAS NO CEMENT ON THE BACK OF THE IMPLANT, INDICATING THAT THE PRODUCT FAILED AND HAD THE CEMENT/IMPLANT INTERFACE. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON (B)(6) 2021. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12386522 ↗
• InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  *US LEGAL* IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2018. THE REVISION SURGERY WAS PERFORMED DUE TO INFECTION.

  Patient problems: Arthralgia; Fibrosis; Medical device site infection; Osteolysis; Unspecified Infection

  MAUDE report 11106298 ↗
• InjuryDec 29, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT AFTER TKA, A REVISION SURGERY WAS PERFORMED DUE TO A GENESIS II NON-POROUS TIBIAL BASEPLATE SIZE 5 RIGHT LOOSENING. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 11086753 ↗
• InjuryNov 25, 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 MEDIAL SUBSIDENCE OF IMPLANT AND LOOSENING. THE TIBIAL BASEPLATE WAS REMOVED. THE PRIMARY OPERATION WAS PERFORMED ON 2016.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 10902029 ↗
• InjuryOct 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS SCHEDULED FOR A PATELLA AND AN INSERT EXCHANGE, HOWEVER DURING PROCEDURE THE FEMORAL IMPLANT CAME OFF BY HAND. PROCEDURE WAS CONCLUDED BY REMOVING ALL COMPONENTS AND INSERTING A CEMENT SPACER AS PART OF A 2 STAGE REVISION.

  Patient problems: Injury

  MAUDE report 10617482 ↗
• InjurySep 20, 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. INITIAL SURGERY WAS PERFORMED ON (B)(6) 2015, WASHOUT AND POLY EXCHANGE DONE APPROXIMATELY 5 MONTHS AGO ( (B)(6)2020). ALL IMPLANTS REMOVED USING SMITH AND NEPHEW RENOVATION GEAR. ANTIBIOTIC FEMUR IMPLANTED WITH ALL POLY TIBIA CR AND ANTIBIOTIC NAIL IN TIBIA. PATIENT OUTCOME IS UNKNOWN. 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 10558090 ↗
• InjuryJan 15, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT FIVE YEARS AGO PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO PAIN OF BOTH KNEES AND WAS DIAGNOSED WITH OSTEOARTHRITIS OF BOTH KNEES. ON (B)(6) 2019, PATIENT HAD A RIGHT KNEE JOINT SURFACE REPLACEMENT PERFORMED. AFTER THE OPERATION, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6). ON (B)(6), THE PATIENT WAS ADMITTED TO THE HOSPITAL AGAIN DUE TO RIGHT KNEE PAIN FOR 2 WEEKS. AFTER THE ADMISSION, AN ANTI-INFECTION TREATMENT WAS GIVEN. AFTER THE TREATMENT, THE PAIN WAS RELIEVED.

  Patient problems: Pain

  MAUDE report 9594212 ↗
• InjuryJan 10, 2020Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth; Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO SEPTIC TIBIAL LOOSENING.

  Patient problems: Injury; No Consequences Or Impact To Patient; Unspecified Infection

  MAUDE report 9577124 ↗
• InjuryDec 15, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT HAS COMPONENTS IN PLACE SINCE (B)(6) 2015 AND WAS EXPERIENCING STIFFNESS, A REVISION SURGERY WAS PERFORMED AND EVERYTHING WAS REMOVED EXCEPT THE PATELLA.

  Patient problems: Injury

  MAUDE report 9471056 ↗
• InjuryOct 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER SURGERY THE PATIENT APPARENTLY SHOWS SOME ALLERGIC REACTION TO THE SYSTEM IMPLANTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 9211441 ↗
• InjurySep 30, 2019Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS REPORTED DUE TO INSTABILITY AND PAIN. THE FEMORAL COMPONENT, THE BASEPLATE AND THE INSERT WERE REPLACED.

  Patient problems: Injury

  MAUDE report 9137588 ↗
• InjuryFeb 18, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT HAD A SILENT STROKE AND WAS ADMITTED TO THE HOSPITAL. SHE SUFFERED OF PAIN, SWELLING AND DISCOMFORT FOR SOME WEEKS. SHE HAD VARIOUS TESTING AND PROCEDURES SINCE THAT, AND SHE REQUESTED SOMETHING FOR PAIN CONTROL.

  Patient problems: Pain; Swelling

  MAUDE report 8348292 ↗
• InjuryFeb 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INCREASING PAIN. NO DELAY TO PROCEDURE WAS REPORTED.

  Patient problems: Injury; Pain

  MAUDE report 8348200 ↗
• InjuryJan 2, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED IN A THAT PATIENT PRESENTED PAIN, POSSIBLY DUE TO A BASEPLATE LOOSENING.

  Patient problems: Pain

  MAUDE report 8210019 ↗

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-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