GENESIS II 71420830Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 03596010209641), received between May 9, 2017 and Feb 20, 2026 — classified as 20 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (10 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 30 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2026Fracture

  IT WAS REPORTED THAT AFTER TKA SURGERY HAD BEEN PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED A CLUNKING SENSATION IN HER KNEE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH THE GII PS INSERT SZ 5-6 9MM WAS REMOVED AND EXCHANGE WITH A NEW ONE. THE SURGEON FOUND THAT THE POST OF THE INSERT HAD BROKEN OFF. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Crepitus

  MAUDE report 24400356 ↗
• InjurySep 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED THE BREAKAGE OF THE INSERT POST. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE GII PS INSERT SZ 5-6 9MM WAS REVISED TO A LEGION DISHED POLY. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22963463 ↗
• InjuryJun 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON 2005, THE PATIENT EXPERIENCED WOBBLY KNEE DUE TO BROKEN POST. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE POLY WAS SWAPPED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 22290817 ↗
• InjuryJul 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER UNDERGOING A TKA ON AN UNKNOWN DATE, PATIENT EXPERIENCED INSERT DETACHMENT FROM THE TIBIAL COMPONENT. IN ADDITION, THERE WAS LUXATION. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING REVISION SURGERY ON (B)(6) 2014, TO EXCHANGE THE GII PS INSERT SZ 5-6 9MM. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity; Nerve Damage; Rupture; Subluxation

  MAUDE report 19745339 ↗
• InjuryJun 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2013, THE PATIENT EXPERIENCED A BREAKAGE OF THE POST OF THE GII PS INSERT SZ 5-6 9MM. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE BROKEN POST WAS EASILY RETRIEVED AND THE REST OF THE INSERT WAS REMOVED WITHOUT DIFFICULTY AND IT WAS REPLACED WITH A NEW PS INSERT SIZE 5-6, 11MM. NO OTHER PROBLEMS WERE FOUND WITH THE REMAINING IM THE CASE. HEALTH STATUS OF THE PATIENT IS UNKNOWN BY THE MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567249 ↗
• InjuryMar 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2012, THE POST OF THE GII PS INSERT SZ 5-6 9MM GOT FRACTURED. THIS ADVERSE EVENT WAS SOLVED BY PERFORMING A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE INSERT WAS EXCHANGED TO A NEW ONE OF THE SAME SIZE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 18907510 ↗
• InjuryFeb 21, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2007, THE PATIENT FELL ONTO HIS KNEES WHILE SLIPPING ON SOME ICE BACK IN (B)(6) 2023. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE GII PS INSERT SZ 5-6 9MM WAS EXCHANGED. CURRENT HEALTH STATUS OF PATIENT IS GOOD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Fall

  MAUDE report 18754445 ↗
• InjuryFeb 17, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A LEFT TKA HAD BEEN PERFORMED ON (B)(6) 2006 WITH OSTEOARTHRITIS AS PRIMARY DIAGNOSIS, THE PATIENT REQUIRED A REVISION SURGERY ON (B)(6) 2021 DUE TO THE FOLLOWING DIAGNOSIS/COMPLICATION(S): FRACTURE OF THE ARTICULAR INSERT. DURING THIS PROCEDURE, THE BROKEN 9MM PS INSERT WAS EXPLANTED AND REPLACED WITH AN IDENTICAL SMITH+NEPHEW ARTICULAR INSERT. 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

  MAUDE report 16396259 ↗
• InjuryJul 26, 2022Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING LEFT TKA, WHEN REDUCING THE GII PS INSERT SZ 5-6 9MM IN THE GNS II CMT TIB SIZE 5 LEFT, THE POSITIONER (IMPACTOR) TIP BROKE. A SMITH AND NEPHEW BACK UP HIGH FLEX POSITIONER WAS USED INSTEAD, HOWEVER THE GNS II CMT TIB SIZE 5 LEFT DID NOT REDUCE (CLICKING NOISE) DESPITE PLACING THE IMPLANT CORRECTLY. THE PHYSICIAN DECIDED TO CHANGE THE TIBIAL BASEPLATE AS THERE WERE NO MORE INSERTS AVAILABLE, THEY RE-CUT THE BONE WITH SIZE 11 POLYETHYLENE. FINALLY, AFTER REMOVING THE BASEPLATE AND CLEANING THE REMAINING CEMENT, A GNS II CMT TIB SIZE 6 LEFT WAS IMPLANTED. A DELAY GREATER THAN 30MIN WAS REPORTED.

  Patient problems: Rupture

  MAUDE report 15108705 ↗
• InjuryJul 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER KNEE REPLACEMENT HAD BEEN PERFORMED IN 2008, THE PATIENT EXPERIENCED AP LAXITY. THIS ADVERSE EVENT WAS SOLVED WITH A REVISION SURGERY ON (B)(6) 2022, IN WHICH THE GII PS INSERT SZ 5-6 9MM WAS FOUND TO BE BROKEN. THE PATIENT IS HEALTHY.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 15108544 ↗
• InjuryMar 23, 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 ON (B)(6) 1998, THE PATIENT EXPERIENCED GENERALIZED PAIN AND SLIGHT LIGAMENT LAXITY. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2022 TO EXCHANGED THE GII PS INSERT SZ 5-6 9MM. ALL COMPONENTS INCLUDING PATELLA AND POLY WERE IN VERY GOOD CONDITION CONSIDERING THE AGE OF THE IMPLANT. PATIENT IS RECOVERING WELL.

  Patient problems: Joint Laxity; Pain

  MAUDE report 13863276 ↗
• MalfunctionNov 12, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING TOTAL KNEE REPLACEMENT, IT WAS OBSERVED THAT A GENESIS II POSTERIOR STABILIZED INSERT SIZE 5-6 9MM HAD A FLANGE ON THE BACK THAT WAS LARGER THAN THE OTHER, FOR WHICH IT WAS NOT FIXED TO THE TIBIAL BAND. FLEXION AND EXTENSION TESTS WERE PERFORMED ON THE PATIENT AND THE INSERT DISLOCATED. SURGERY WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12804922 ↗
• MalfunctionOct 18, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE STICKERS THAT WERE STICKED ON THE IMPLANT BOX WITH THE GII PS INSERT SZ 5-6 9MM INFORMATION (PN: 771420830 LN: 21DM05384), DID NOT MATCH WITH THE INFORMATION ON THE STICKERS INSIDE THE BOX. INSTEAD, THE GII PS INSERT SZ 5-6 11MM INFORMATION (PN: 771420832 LN: H2011169) WAS CONTAINED. THIS WAS NOTICED AFTER USE IN PATIENT. SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO HARM TO THE PATIENT OR ANY FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647908 ↗
• 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 11821427 ↗
• MalfunctionApr 2, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A PRIMARY TKA SURGERY, THE GII PS INSERT SZ 5-6 9MM COULD NOT BE DRIVEN INTO THE ANTEROLATERAL LOCKING MECHANISM SLOT OF THE TIBIAL BASEPLATE DURING INSTALLATION. AFTER REPEATED CLEANING OF THE ANTERIOR AND POSTERIOR LOCKING MECHANISM SLOT OF THE TIBIAL BASEPLATE AND THE SURROUNDING SOFT TISSUES, COMPLETE LOCKING COULD NOT BE PERFORMED EVENTUALLY. PROCEDURE FINISHED WITH S/N BACKUP DEVICE. UNKNOWN IF THERE WAS A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610576 ↗
• MalfunctionApr 2, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A PRIMARY TKA SURGERY, THE GII PS INSERT SZ 5-6 9MM COULD NOT BE DRIVEN INTO THE ANTEROLATERAL LOCKING MECHANISM SLOT OF THE TIBIAL BASPLATE DURING INSTALLATION. AFTER REPEATED CLEANING OF THE ANTERIOR AND POSTERIOR LOCKING MECHANISM SLOT OF THE TIBIAL BASEPLATE AND THE SURROUNDING SOFT TISSUES, COMPLETE LOCKING COULD NOT BE PERFORMED EVENTUALLY. PROCEDURE FINISHED WITH S/N BACKUP DEVICE. SURGICAL DELAY OF LESS THAN OR EQUAL TO 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610550 ↗
• MalfunctionMar 12, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, INSIDE THE PATIENT, WHILE USING A GII PS INSERT SZ 5-6 9MM, THE POLY INSERT WAS DEFORMED AND IT COULD NOT LOCK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH+NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11468370 ↗
• MalfunctionDec 8, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT, A GENESIS II PS INSERT SIZE 5-6 9MM DID NOT LOCK IN PLACE CORRECTLY. INCIDENT OCCURRED DURING A TKA WITH INSTRUMENTS INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE WITH A LESS THAN 30MIN DELAY. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. BACKUP IMPLANT USED WITH NO OTHER ISSUES. 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 10967384 ↗
• InjuryNov 18, 2020Break; Break

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED, A REVISION SURGERY WAS PERFORMED TO EXCHANGE THE GENESIS II PS INSERT SIZE 5-6 9MM DUE TO A BROKEN POST. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 10859797 ↗
• MalfunctionOct 28, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A TKA PROCEDURE THE GENESIS II PS INSERT SIZE 5-6 9MM COULD NOT BE FIXED INTO THE RIGHT KNEE. IT WAS REPLACED BY AN IDENTICAL S+N BACKUP INLAY AND WAS PLACED WITHOUT PROBLEMS. SURGERY WAS DELAYED FOR NO MORE THAN 30 MIN. DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10745055 ↗
• MalfunctionOct 27, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A TKA PROCEDURE THE GENESIS II PS INSERT SIZE 5-6 9MM COULD NOT BE FIXED INTO THE RIGHT KNEE; IT WAS REPLACED BY AN IDENTICAL S+N BACKUP INLAY AND WAS PLACED WITHOUT PROBLEMS. SURGERY WAS DELAYED FOR NO MORE THAN 30 MIN. DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10741473 ↗
• MalfunctionOct 26, 2020Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING TKA PROCEDURE THE GII PS INSERT SZ 5-6 9MM COULD NOT BE FIXED DURING PRIMARY SURGERY. THIS HAPPENED DURING USE INSIDE THE PATIENT. IT WAS REPLACED BY AN IDENTICAL BACKUP INSERT. THE BACK UP COULD BE INSERTED WITHOUT FURTHER PROBLEMS. A DELAY OF LESS THAN 30 MIN WAS REPORTED. NO INJURIES REPORTED AT THIS TIME. DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10738184 ↗
• MalfunctionAug 15, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING THE TKA PROCEDURE, AFTER TIBIA AND FEMUR IMPLANTATION, THE SURGEON TRIED TO INSERT THE GENESIS II PS INSERT SIZE 5-6 9MM. BUT WAS UNSTABLE. THE INSERT WAS MOVING EVEN AFTER USING LOCKING DEVICE; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10411818 ↗
• InjuryAug 13, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT ONCE THE DEFINITIVE IMPLANTS WERE PLACED (FEMUR, TIBIA), THE DEVICE 71420830 BATCH H1817411 WAS PLACED. EXTENSION TESTS WERE CARRIED OUT AND AFTER THE FLEXION, THE DEVICE THROW AWAY. 3 ATTEMPTS WERE MADE WITH THE DEVICE UNSUCCESSFULLY AND A SMALLER INSERT WAS USED IN ORDER TO COMPLETE THE PROCEDURE. THIS IS THE SECOND COMPLAINT WITH SAME PROBLEM IN THE SAME PROCEDURE. FIRST WAS WITH THE ITEM (B)(4) BATCH H1813400 AND SECOND WAS THIS. PROCEDURE WAS COMPLETED USING A BACK UP DEVICE. NO DAMAGE TO PATIENT OCCURRED. PROCEDURE WAS COMPLETED SUCCESFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8888655 ↗
• 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 8036207 ↗

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