GENESIS II 71421524Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010492999), received between Oct 15, 2018 and Sep 5, 2024 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (3 reports).

6 other recalls cover devices cleared under the same FDA submission (K032295); 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A RIGHT TKA SURGERY PERFORMED APPROXIMATELY 12 YEARS AGO, THE PATIENT EXPERIENCED DISCOMFORT AND CLICKING. THE PATIENT WAS BOOKED FOR A DEBRIDEMENT OF OSTEOPHYTES AND BONE FRAGMENTS OF THE RIGHT KNEE. WITH ARTHROTOMY, THE SURGEON NOTICED THAT THE INSERT PEG WAS BROKEN OFF AND REQUESTED AN INSERT TO REPLACE. THERE IS NO HISTORY OF AN INJURY TO THE KNEE POST-OP TKA, BUT THE SURGEON SAID THAT THE PATIENT WAS NOT VERY COMPLIANT IN TAKING CARE OF HIS HEALTH, HE IS NOT CAREFUL ABOUT THE ACTIVITIES HE ENGAGES IN. THE CURRENT HEALTH STATUS OF THE PATIENT IS HEALTHY.

  Patient problems: Discomfort; Failure of Implant

  MAUDE report 20146349 ↗
• InjuryJul 12, 2024Adverse 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 HAD BEEN PERFORMED ON (B)(6) 2018. THE PATIENT EXPERIENCED INSTABILITY AND WEAR ON THE KNEE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, IN WHICH ONE (1) GII PS HI FLEX ISRT SZ 7-8 13 AND ONE (1) GNS II RESURF PAT 35MM WERE EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 19735251 ↗
• InjuryJul 18, 2023Fracture; Fracture

  IT WAS REPORTED THAT, FOLLOWING A LEFT TKA SURGERY PERFORMED 15 YEARS AGO, THE PATIENT EXPERIENCED AN INCIDENT AND NOTICED A "DIFFERENCE IN THE KNEE". X-RAYS REVEALED POTENTIAL BREAKAGE OF THE PS ARTICULAR INSERT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, A SYNOVECTOMY AND DEBRIDEMENT OF THE JOINT WAS PERFORMED. THE BROKEN HARDWARE WAS CONFIRMED AND EXTRACTED, AND CEMENT DEBRIS FROM THE POSTERO-LATERAL COMPARTMENT WAS ALSO REMOVED. PATIENT'S CURRENT HEALTH STATUS IS GOOD.

  Patient problems: Failure of Implant

  MAUDE report 17347286 ↗
• MalfunctionJun 21, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A REVISION SURGERY THAT REQUIRED A KNEE JOINT REPLACEMENT. THE GII PS HI FLEX ISRT SZ 7-8 INSERT COULD NOT BE IMPLANTED. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH AN S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17177210 ↗
• InjuryJul 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2015, A GENESIS II PS HIGH FLEXION INSERT SIZE 7-8 13MM WAS FOUND TO HAVE A BROKEN POST. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2022. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 15070035 ↗
• InjuryFeb 4, 2022Loosening 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) 2015, THE PATIENT EXPERIENCED ASEPTIC LOOSENING ON (B)(6) 2022. REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO EXPLANT A (B)(6) SZ 7-8 13. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 13457677 ↗
• InjuryDec 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, THE PATIENT HAD RECURRENT PATELLA SUBLUXATION/DISLOCATION. IT WAS PREVIOUSLY TREATED WITH EXTENSOR MECHANISM REPAIR 1.5 YEARS AGO, BUT IT FAILED. AT THE TIME, SURGEON ATTRIBUTED THE PROBLEM TO THE LEGION PS OXINIUM FEMORAL SZ 8 LEFT (-1) FOR POSSIBLE MALROTATION. ON (B)(6) 2021, THE PATIENT UNDERWENT A REVISION SURGERY WHERE THE LEGION PS OXINIUM FEMORAL SZ 8 LEFT (CASE- (B)(4)) AND THE GII PS HIGH FLEXION INSERT SZ 7-8 13MM (CASE- (B)(4)) WERE EXCHANGED. MORE EXTERNAL ROTATION WAS APPLIED TO THE FEMORAL COMPONENT AND TIBIAL TUBERCLE TRANSFER AND EXTENSOR MECHANISM REPAIR WERE PERFORMED. ALSO, IT WAS NOTED THAT PRIOR TO PRIMARY TKR, PATIENT HAD BOTH FEMORAL AND TIBIAL OSTEOTOMIES. SURGEON COMMENTED THAT THIS MAY BE ATTRIBUTABLE TO OUTCOMES, AS ANATOMY 'DISTORTED'. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation; Subluxation

  MAUDE report 13095008 ↗
• InjuryNov 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAS BEEN PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6)2021, IN WHICH THE GII OXIN P/S FEM RIGHT SIZ 8, GII PS HI FLEX ISRT SZ 7-8 13, GEN II MIS TIB BASE CEM SZ8 RT AND GII OVAL RESURFACING PAT 38MM WERE EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12847965 ↗
• InjuryMay 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 AND THE LEGION PS OXIN FEM SZ7 LT ((B)(4)), THE GNS II CMT TIB SIZE 7 LEFT ((B)(4)) AND THE GII PS HI FLEX ISRT SZ 7-8 13 ((B)(4)) WERE REMOVED FROM THE PATIENT AND REPLACED WITH SMITH AND NEPHEW DEVICES. THERE IS NOT SPECIFIC INFORMATION ABOUT THE NEW IMPLANTS THAT WERE USE IN THE REVISION SURGERY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 11814223 ↗
• InjuryOct 15, 2018Adverse 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 A REVISION SURGERY WAS PERFORMED DUE TO AN INFECTION. FEMORAL AND TIBIAL IMPLANT EXTRACTED. DELAY OF LESS THAN 30MIN REPORTED. BACK UP AVAILABLE.

  Patient problems: Injury; No Information; No Known Impact Or Consequence To Patient; Unspecified Infection

  MAUDE report 7967792 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032295. One submission often covers many models, so check the product and lot details in each record.

• Z-0445-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), REF 71420820, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0448-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0447-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), REF 71421515, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0449-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), REF 71621509, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0446-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0444-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1), REF 71420806, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic