GENESIS II 71420164Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 03596010206251), received between Nov 13, 2017 and Jul 20, 2026 — classified as 27 injuries, 4 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 31 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2026Malposition of Device

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2026 DUE TO MALALIGNMENT OF THE TIBIAL COMPONENT. THE ADVERSE EVENT WAS RESOLVED WITH THE REPLACEMENT OF ONE (1) GII PS HI FLEX ISRT SZ 3-4 11 AND ONE (1) GNS II CMT TIB SIZE 3 LEFT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25884095 ↗
• MalfunctionAug 18, 2025Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING THE SETUP AND INSPECTION FOR A TKA SURGERY, IT WAS NOTICED THAT THE INNER PACKAGING OF ONE GNS II CMT TIB SIZE 3 LEFT WAS COMPROMISED, AND THE SURGEON DID NOT TRUST ITS STERILITY. THE PROCEDURE WAS PERFORMED WITHOUT ANY SURGICAL DELAY USING A S+N BACKUP DEVICE. SINCE THE INCIDENT OCCURRED BEFORE THE PROCEDURE, THE PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22836106 ↗
• MalfunctionJul 10, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT THE STERILE PACKAGING OF A GNS II CMT TIB SIZE 3 LEFT WAS DAMAGED UPON OPENING OF PRODUCT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22465830 ↗
• InjuryApr 13, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING DICTATION AFTER A RIGHT TKA HAD BEEN PERFORMED, THE SURGEON NOTICED THAT A LEFT TIBIAL BASE PLATE WAS IMPLANTED. THEY RE-OPENED THE PATIENT, WHO WAS STILL UNDER ANESTHESIA, AND REMOVED THE INCORRECT TIBIAL IMPLANT TO REPLACE IT WITH THE CORRECT SIDE TIBIAL IMPLANT. THE LINER WAS ALSO EXCHANGED FOR A LARGER SIZE DUE TO THE IMPLANTING. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14103546 ↗
• 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 14068377 ↗
• MalfunctionMar 3, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THREE GII DISHED INS SZ 3-4 9MM AND ONE GII C/R ART INS SZ 3-4 9MM COULD NOT BE INSERTED FAR ENOUGH INTO THE DOVETAIL GUIDE AND BE FINALLY FIXED IN THE ALREADY IMPLANTED GNS II CMT TIB SIZE 3 LEFT (LOT NO. H2136412). A FIFTH ATTEMPT WAS MADE WITH A LGN XLPE DISHED ISRT SZ 3-4 9MM, WHICH COULD BE FIXED IN THE TIBIA BY USING AN ADDITIONAL HAMMER BLOWS AND FORCE. A SIGNIFICANT DELAY OCCURRED AS A CONSEQUENCE OF THESE ISSUES. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13664303 ↗
• MalfunctionDec 6, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT (B)(4) UNITS, MANUFACTURED IN 128 LOTS FROM 3 CATALOGUE NUMBERS OF GENESIS IITIBIAL BASE PLATES (71420164, 71420166 AND 71420184), WERE REMOVED FROM THE FIELD FOR SCRAPPING. AT THE (B)(4) SITE ON 14 FEB 2020, A NON-HOMOGENOUS MATERIAL ISSUE WAS DETECTED IN THE MACHINED BASE PLATE. THE INCLUSION THAT WAS DETECTED IS A HARD, BRITTLE ALPHA PHASE ENRICHED WITH OXYGEN AND NITROGEN. THE HARD-BRITTLE ALPHA PHASE INCREASES THE RISK OF VOIDS BUILDING IN THE BAR ROLLING PROCESS. BOTH THE PRESENCE OF THE HARD, BRITTLE PHASE AS WELL AS THE PRESENCE OF VOIDS COULD POTENTIALLY INCREASE THE RISK OF PREMATURE FATIGUE FAILURE, PARTICULARLY IN HIGH STRESS AREAS OF THE DEVICE. AS S+N HAS NOT RECEIVED ANY PRODUCT COMPLAINT ASSOCIATED TO THIS ISSUE, S+N IS REPORTING PURSUANT 21 CFR 806, FOR THE REMEDIAL ACTION THAT WAS TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12942483 ↗
• InjuryNov 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT'S LEFT KNEE ON (B)(6) 2021, THE PATIENT EXPERIENCED SWELLING AND REDNESS IN THE JOINT. DUE TO THESE SYMPTOMS, THE PATIENT WAS READMITTED TO THE HOSPITAL AND TREATED WITH ANTICOAGULANTS, DETUMESCENCE AND OTHER UNSPECIFIED SYMPTOMATIC TREATMENT. A SMALL AMOUNT OF EXUDATE IN THE EPIDERMAL WOUND WAS CULTURED, REVEALING A POSITIVE RESULT ON THE PRESENCE OF (B)(6). (B)(6) WERE ADMINISTERED TO TREAT THIS ADVERSE EVENT. THE PATIENT WAS DISCHARGED AFTER THE INFECTION INDEX WAS REDUCED. THE PATIENT RECOVERED WELL AND WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Bacterial Infection; Erythema; Post Operative Wound Infection; Swelling/ Edema

  MAUDE report 12751445 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PLAINTIFF UNDERWENT MEDICALLY-INDICATED REVISION SURGERY OF THE LEFT KNEE ON 13-SEP-2019 DUE TO CHRONIC PAIN, WHICH THE PATIENT PRESENTED SINCE (B)(6) 2017. DURING THIS PROCEDURE, THE PATELLAR COMPONENT AND THE INSERT WERE EXCHANGED. THE PRIMARY TKR WAS PERFORMED ON (B)(6) 2014. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12595386 ↗
• InjurySep 24, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, THE PATIENT EXPERIENCED A GNS II POROUS P/S FEM SZ4 LT AND A GNS II CMT TIB SIZE 3 LEFT LOOSENING. THIS ADVERSE EVENT LED TO A REVISION SURGERY PERFORMED ON (B)(6) 2021 IN WHICH METALOSIS WAS OBSERVED AND POLYETHYLENE SHOWED VERY LITTLE SIGNS OF WEAR. IN ADDITION IT WAS DISCOVERED THAT THE NATIVE PATELLA HAD WORN ON THE TROCHLEAR GROOVE OF THE FEMORAL IMPLANT, RELEASING METAL DEBRIS INTO THE JOINT. THE GNS II POROUS P/S FEM SZ4 LT, THE GNS II CMT TIB SIZE 3 LEFT AND THE GNS II CMT TIB SIZE 3 LEFT WERE EXPLANTED IN THE REVISION SURGERY. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Inadequate Osseointegration; Metal Related Pathology

  MAUDE report 12527220 ↗
• InjuryFeb 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA, PATIENT PRESENTED PAIN AND A REVISION SURGERY WAS PERFORMED TO EXPLANT THE GENESIS II NON-POROUS TIBIAL BASEPLATE SIZE 3 LEFT. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 11305634 ↗
• InjuryDec 7, 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 TIBIAL BASEPLATE BEING LOOSE. SURGEON EXPLANTED THE BASEPLATE. FEMUR WAS WELL FIXED AND LEFT IN-SITU. PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 10956951 ↗
• InjuryAug 18, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT A REVISION OF LEFT TKR WAS PERFORMED DUE TO PATIENT PRESENTING WITH PAIN WITH SLIGHT MALALIGNMENT/MALROTATION OF IMPLANT COMPONENTS. PRIMARY LEFT TKR WAS PERFORMED ON (B)(6) 2017. DURING REVISION SURGERY THE GENESIS II NON-POROUS TIBIAL BASEPLATE SIZE 3 LEFT WAS REMOVED WITH RENOVATION KNEE GEAR. ORIGINAL OVAL 32MM PATELLA WAS RETAINED BY SURGEON. BONY CANALS AND SURFACES WERE PREPPED FOR A 5 LEFT LEGION REVISION FEMUR, 3 LEFT REVISION TIBIA WITH TIBIAL AND FEMORAL STEMS USED WITH OFFSET COUPLERS AND AUGMENTED FEMORAL COMPONENT. THE COMPONENTS WERE TRIALLED WITH ROM CHECK BEFORE IMPLANTATION. THE COMPONENT IMPLANTS USED WERE CEMENTED IN WITH PALACOS CEMENT AND CONSTRAINED 3-4 18MM INSERT IMPLANTED AFTER CEMENT CURING. THE WOUND WAS WASHED AND IRRIGATED, AND BETADINE/SALINE SOAKED, AND THEN CLOSED IN LAYERS AS PER STANDARD TECHNIQUE.

  Patient problems: Injury

  MAUDE report 10418673 ↗
• InjuryJan 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION WAS PERFORMED DUE TO PERIPROSTHETIC INFECTION OF THE LEFT KNEE. THREE COMPONENTS WERE EXPLANTED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9566786 ↗
• InjuryDec 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO TIBIA STEM PAIN THAT LIMITED THE PATIENT¿S MOBILITY AND HOT SPOT IDENTIFIED WITH SCANS. THE FEMUR AND TIBIA COMPONENTS WERE WELL FIXED. A CEMENTED STEM, BASEPLATE, AND TIBIAL AUGMENTS WERE CEMENTED IN PLACE AND LATER THE POLY WAS INSERTED. THERE WERE NO CHANGES TO THE FEMUR. NO OPERATIVE REPORTS ARE AVAILABLE.

  Patient problems: Pain

  MAUDE report 9406828 ↗
• InjuryOct 3, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT HAD HER PRIMARY TKA DONE ON (B)(6) 2019 AFTER WHICH SHE DAMAGED HER COLLATERAL LIGAMENTS. REVISION CASE WAS DONE WITH STANDARD SURGICAL TECHNIQUE AND REMOVAL OF IMPLANTS IN SITU. CLINICAL AND INTRA-OPERATIVE FINDINGS SHOWED SEVERE DAMAGE TO THE MEDIAL AND LATERAL COLLATERAL LIGAMENTS. THIS CAUSED INSTABILITY AND PRIMARY KNEE NEEDED TO BE REVISED TO A HINGE PROSTHESIS.

  Patient problems: Injury

  MAUDE report 9150991 ↗
• InjuryAug 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS ON THE LEFT KNEE.

  Patient problems: Injury

  MAUDE report 8931583 ↗
• InjuryJul 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 8844183 ↗
• InjuryJun 27, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A LEFT TIBIAL BASEPLATE AND LEFT FEMORAL COMPONENT WERE IMPLANTED IN THE PATIENT'S RIGHT KNEE. THIS WAS NOTICED IN POST-OP XRAY. PATIENT ELECTED NOT TO GO BACK TO SURGERY.

  Patient problems: Not Applicable

  MAUDE report 8742157 ↗
• InjuryJun 14, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THA THE TIBIA AND POLY WERE REMOVED DURING A REVISION SURGERY. THE TIBIA WAS LOOSE UPON OPENING THE JOINT CAPSULE. IT WAS REMOVED WITH NO CEMENT ADHERED TO THE BASEPLATE.

  Patient problems: Injury

  MAUDE report 8700950 ↗
• InjuryMay 2, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO POSTERIOR KNEE PAIN. FURTHER INFORMATION IS UNKNOWN YET.

  Patient problems: Pain

  MAUDE report 8574044 ↗
• InjuryMar 6, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  LEGION PRIMARY WITH VERILAST, STUDY ID: (B)(6); SUBJECT# (B)(6); AE#01: TKR LOOSENING SUSPICION. IT WAS REPORTED THAT A YEAR AFTER TKR IT IS SUSPECTED THAT PATIENT HAS LOOSE COMPONENTS AND A REVISION SURGERY WAS PERFORMED.

  Patient problems: Injury

  MAUDE report 8394846 ↗
• InjuryFeb 5, 2019Misassembled; Misassembled

  A REVISION SURGERY WAS PERFORMED DUE TO THE POLY CAME OUT OF THE TIBIA CAUSING METAL WEAR.

  Patient problems: Injury

  MAUDE report 8305183 ↗
• InjuryNov 27, 2018Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Injury

  MAUDE report 8107640 ↗
• InjuryOct 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT SERIOUS INJURY HAS OCCURED. IT TOOK A LOT OF EFFORT TO REMOVE THE TIBIA AND BONE CEMENT LOOSENED AND TOOK AWAY PART OF THE BONE MASS. ALSO NEED TO RE-SELECT A LARGER PROSTHESIS.

  Patient problems: Injury

  MAUDE report 7971318 ↗

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