GENESIS II 71420816Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 03596010209573), received between Jun 7, 2017 and Feb 9, 2026 — classified as 15 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (6 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 39 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2026Fracture

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED IN 2010, THE PATIENT SUDDENLY FELT HER KNEE BECOME UNSTABLE. IT WAS DETERMINED THAT ONE (1) GII PS INSERT SZ 3-4 9MM WAS FRACTURED. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH THE GII PS INSERT SZ 3-4 9MM WAS EXPLANTED AND REPLACED WITH A 3-4-13MM CONSTRAINED INSERT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 24293385 ↗
• MalfunctionSep 18, 2023Positioning Failure; Positioning Failure

  IT IS REPORTED THAT, DURING A TKA SURGERY, THE CORRECT EXPOSURE OF THE TIBIA WAS PERFORMED TO PLACE A GII PS INSERT SZ 3-4 9MM, THE POSITIONING OF THE INSERT WAS PERFORMED AND SUBSEQUENTLY IMPACTED TO LOCK INTO THE TIBIAL BASEPLATE, BUT IT WAS NOTICED THAT THERE WAS A GAP BETWEEN THE INSERT AND THE TIBIA, IT WAS IMPACTED WITHOUT ACHIEVING PROPER INSERTION, THIS PROCESS WAS ATTEMPTED 3 TIMES, DUE TO THE SURGICAL TIME THE SURGEON INDICATED TO SWITCH TO A BACKUP. A GII PS INSERT SZ 3-4 11MM WAS PLACED, AND IT MADE THE PROPER LOCKING EASILY. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A BACKUP S+N DEVICE. NO INJURIES WERE REPORTED AS A RESULT OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17764237 ↗
• MalfunctionJun 5, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED, THAT DURING A TKA SURGERY. AFTER THE TIBIAL BASE SURFACE WAS CLEANED, WHEN PLACING THE GII PS INSERT SZ 3-4 9MM, WITH THE GII ARTICULAR INSERTER/EXTRACT WITHOUT OBTAINING THE CLICK. THAT INDICATES THE CORRECT ANCHORAGE AND AFTER TRYING IT AGAIN, THE TIBIAL COMPONENT LODGED. IT WAS DECIDED, TO REMOVE THE IMPLANT (TIBIAL BASE AND INSERT). ON THE TABLE, THE INSERT WAS TESTED AGAIN OBTAINING THE SAME RESULT. THE SPECIALIST DETERMINED, TO RE-CEMENT THE COMPONENT AND PLACE AN GII PS INSERT SZ 3-4 11MM INSTEAD. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17063651 ↗
• InjuryJul 7, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A TKA PERFORMED ON (B)(6) 2005, THE GENESIS II POSTERIOR STABILIZED INSERT SIZE 3-4 9MM BROKE OFF AND CAUSED INSTABILITY. THIS WAS NOTED DURING A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 WHERE WAS REPLACED FOR A THICKER STABILIZER. CURRENT STATE OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 12132316 ↗
• MalfunctionMay 12, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GII PS INSERT SZ 3-4 9MM 3-8 EASILY COMES OUT OF THE TIBIA. THE PROCEDURE WAS COMPLETED, WITH A DELAY LESS THAN 30 MIN, USING A S+N BACK-UP DEVICE. NO PATIENT INJURIES AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11810793 ↗
• MalfunctionApr 18, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING TKA SURGERY, WHEN PLACING THE DEFINITIVE IMPLANTS, THE GII PS INSERT SZ 3-4 9MM DID NOT FIT IN THE TIBIAL BASE, WHICH MADE IT NOT FIT WELL. IT WAS TRIED SEVERAL TIMES, THE SURFACE WAS CLEANED AND IT WAS TRIED IN SEVERAL WAYS TO PLACE IT, WITHOUT SUCCESS. THEREFORE AFTER SEVERAL MINUTES IT WAS DECIDED TO USE ANOTHER IMPLANT OF THE SAME REFERENCE WHICH WORKED AND FIT PERFECTLY ON THE FIRST TRY. PATIENT'S HEALTH CONDITION IS STABLE. THE PROCEDURE WAS COMPLETED WITH A LESS THAN 30 MINS DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683569 ↗
• MalfunctionApr 18, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING TKA SURGERY, AFTER CEMENTING OF THE PROSTHESES THE GENESIS II PS INSERT SIZE 3-4 9MM WAS PLACED, BUT IT DID NOT FIT PERFECTLY IN THE DOVE TAIL OF THE BASEPLATE. AFTER EVERY ATTEMPT THE INSERT WAS CHECKED FOR DAMAGES BUT NOTHING COULD BE FOUND. AFTER THREE ATTEMPTS, A NEW INSERT FROM SMITH AND NEPHEW WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS FINISHED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683529 ↗
• MalfunctionMar 17, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING TKA SURGERY WHEN PLACING THE FINAL GII PS INSERT SZ 3-4 9MM, HAVING CLEANED AND WASHED THE TIBIAL BASE VERY WELL, THE INSERT DID NOT STAY IN THE PLACE IT SHOULD. IT LOST STABILITY VERY EASILY AND FELL OUT OF PLACE. IT WAS TRIED ON SEVERAL OCCASIONS BUT IT WAS IMPOSSIBLE, IT WAS DECIDED TO USE ANOTHER SMITH AND NEPHEW BACK UP DEVICE OF THE SAME REFERENCE WHICH FIT PERFECTLY IN THE FIRST ATTEMPT. THERE WAS A DELAY OF LESS THAN OR EQUAL TO 30 MINS. NO DAMAGE CAUSED. PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11500212 ↗
• InjuryFeb 15, 2021Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT, A REVISION SURGERY WAS PERFORMED IN ORDER TO REPLACE A GENESIS II PS INSERT SIZE 3-4 9MM. THE SURGERY WAS PERFORMED DUE TO THE PAIN EXPERIENCED BY THE PATIENT, AND BECAUSE IT WAS CONFIRMED THROUGH A SCAN THAT A POLYETHYLENE FRAGMENT WAS PRESENT IN THE QUADRICIPITAL CUL-DE-SAC. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 11326554 ↗
• MalfunctionFeb 14, 2021Defective Component; Connection Problem; Defective Component; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY, AFTER MULTIPLE ATTEMPTS, THE 3/4-9MM POSTERIOR STABILIZED ARTICULAR INSERT WOULD NOT LOCK. PROCEDURE CONTINUED WITH A BACKUP DEVICE FROM SMITH AND NEPHEW OF THE SAME SIZE AND WITH A DELAY GREATER THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326148 ↗
• MalfunctionDec 15, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING A RIGHT TKA SURGERY, THE INSERT COULDN'T BE LOCKED TIGHTLY INTO THE BASEPLATE. FINALLY ANOTHER SAME SIZE INSERT WAS USED TO COMPLETE THE SURGERY. NO INJURY TO THE PATIENT WAS REPORTED. 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 11013902 ↗
• InjuryDec 12, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA THE GENESIS II PS INSERT SIZE 3-4 9MM DIDN´T FULLY FIT INTO THE TIBIAL PLATEAU, THEREFORE IT WAS REMOVED AND AN INSERT OF A THICKER MEASURE (3-4, 11MM) WAS PLACED. THE PROCEDURE WAS COMPLETED WITH A MINIMAL DELAY USING A SMITH-NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10996988 ↗
• InjuryNov 19, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING A RIGHT TKA SURGERY, THE EARLY STAGE OF SURGERY WAS VERY SMOOTH. THE 3-4 / 9MM TIBIAL TRIAL WAS COMPLETELY SUITABLE, BUT IT COULD NOT BE IMPLANTED WITH THE REAL INSERT. THE SURGEON REMOVED THE INSERT, CLEANED THE BASEPLATE AND INSERT, AND INSTALLED IT FOR MORE THAN THREE TIMES, BUT COULD NOT BE IMPLANTED. FINALLY ANOTHER SAME SIZE INSERT FROM S+N WAS USED TO COMPLETE THE SURGERY. A DELAY GREATER THAN 30 MINUTES WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10868990 ↗
• MalfunctionOct 26, 2020Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT, DURING TKA PROCEDURE, THE GII PS INSERT SZ 3-4 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.

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

  MAUDE report 10733892 ↗
• MalfunctionOct 22, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING SURGERY, WHILE TRYING TO PLACE THE GII PS INSERT SZ 3-4 9MM, WHICH APPARENTLY HAS NO DEFECT, IT DID NOT FIT. ANOTHER INSERT WAS TRIED AND IT COULD BE INSERTED WITHOUT ANY PROBLEM. NO DELAY TO PROCEDURE. NO INJURIES OR OTHER COMPLICATIONS WERE REPORTED AT THIS TIME.

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

  MAUDE report 10722295 ↗
• MalfunctionOct 8, 2020Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING SURGERY, A 9MM INSERT WOULD NOT LOCK TIGHTLY IN BASEPLATE. A BACKUP INSERT OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO INJURY OR DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10648200 ↗
• InjuryMay 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A TOTAL KNEE REPLACEMENT, GII WAS USED. WHILE INSTALLING THE GII PS INSERT SZ 3-4 9MM, THE FRONT EDGE OF THE INSERT ONLY COULD BE PARTIALLY STUCK IN: THE INSERT CAME OUT WHEN RESETTING. THE PROBLEM WAS REPEATED SEVERAL TIMES. THE SURGERY WAS COMPLETED, WITH NO DELAY, BY USING A DIFFERENT IMPLANT, WHICH DROVE TO A CHANGE OF THE ORIGINAL PLAN. THE PATIENT WAS NOT HARMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10037329 ↗
• MalfunctionJan 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING SURGERY, STABILIZED POSTERIOR INSERT PRESENTED FAILURES AS IT DID NOT LOCKED; GOOD EXPOSURE OF THE TIBIAL BASE WAS PERFORMED, IT WAS CHECKED THAT IT WOULD BE FREE OF TISSUE AND THE INSERT WILL SLIDE, WHICH DID NOT LOCK; SEVERAL ATTEMPTS WERE USED WHICH WERE FAILED. IT WAS DECIDED TO PASS ANOTHER STABILIZED POSTERIOR INSERT 3 4 9MM. DELAY OF 30 MINUTES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9586037 ↗
• MalfunctionJan 3, 2020Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING SURGERY, WHILE IMPLANTING THE INSERT IT WAS NOTICED THAT IT DIDN'T FIT CORRECTLY. DOCTOR REMOVED IT AND DISLOCATED THE TIBIA COMPLETELY, HOWEVER THE INSERT DID NOT COME DOWN WELL IN THE TIBIAL TRAY. ANOTHER INSERT OF THE SAME SIZE WAS USED HOWEVER THIS AGAIN, DID NOT FIT WELL. DOCTOR HAD TO IMPACT IT TO FIX IT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO INJURY REPORTED. IT IS UNKNOWN IF THERE WAS A DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9546195 ↗
• MalfunctionDec 2, 2019Blocked Connection; Blocked Connection

  IT WAS REPORTED THAT DURING THE TOTAL KNEE SURGERY, THE 3-4 9MM INSERT COULDN'T BE IMPLANTED , THE INSERT (NO. 3-4 9MM) FAILED TO IMPLANT. FINALLY A S&N 3-4 11MM INSERT WAS USED TO COMPLETE THE SURGERY.

  Patient problems: Injury

  MAUDE report 9395998 ↗
• MalfunctionOct 17, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A RIGHT KNEE REPLACEMENT SURGERY, THE 9 MM LINER COULDN'T BE IMPLANTED COMPLETELY AND WAS EASY TO FALL OFF SINCE THERE IS A 1 MM GAP BETWEEN LINER AND TIBIA. FINALLY A 11 MM LINER WAS USED TO COMPLETE THE SURGERY. NO INJURIES OR DELAYS REPORTED. A DELAY GREATER THAN 30 MIN WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9205347 ↗
• MalfunctionJun 27, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, WHEN FINAL TIBIAL INSERT WAS PLACED WITH SIZE 3-4 OF 9 MM (HEIGHT), IT WAS EVIDENT THAT IT DID NOT FIT PERFECTLY, LEAVING A LIGHT OF SPACE BETWEEN THE TIBIAL PLATE AND THE INSERT. SEVERAL ATTEMPTS WERE MADE WITH THE CORRESPONDING POSITIONER, BUT IT WAS NOT POSSIBLE TO GET A PERFECT PLACEMENT, IT WAS NECESSARY TO HIT IT WITH THE HAMMER. PROCEDURE DELAYED NO LONGER THAN 30 MINUTES. NO BACKUP WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8738219 ↗
• MalfunctionApr 24, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE INSERT DID NOT FIT IN THE TIBIAL COMPONENT DURING A TOTAL KNEE REPLACEMENT SURGERY. NO INJURIES OR DELAYS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8544188 ↗
• MalfunctionApr 1, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING SURGERY AFTER INSERTION OF THE TIBIA COMPONENT, THE INSERT COULD NOT BE REMOVED. THAT'S WHY THE DOCTOR HAD TO PASS TO AN OVERSIZED INSERT. A BACKUP DEVICE WAS AVAILABLE AND IT IS UNKNOWN IF THERE WAS A DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8468216 ↗
• InjuryFeb 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A REVISION SURGERY WAS PERFORMED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8374621 ↗

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