GENESIS II 71440490Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 03596010329905), received between Aug 2, 2017 and May 7, 2026 — classified as 3 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Break” (17 reports).

2 other recalls cover devices cleared under the same FDA submission (K123598); 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A PRIMARY KNEE REPLACEMENT SURGERY, AT THE TIME OF PLACING THE DEFINITIVE FEMUR IMPLANT ONE (1) GII FEM LOCK IMPL IMPACTOR DISASSEMBLED, IT WAS EVIDENT THAT THE SCREW CAME OUT OF THE HEAD, AS WELL AS ACCESSORY SCREWS AND ITS SPRINGS. NO PIECE FELL INTO THE PATIENT'S WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112549 ↗
• MalfunctionJul 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING TKA SURGERY, WHEN THE DEFINITIVE FEMUR WAS BEING IMPACTED, ONE OF THE SCREWS OF ONE (1) GII FEM LOCK IMPL IMPACTR WAS LOOSENED AND DISASSEMBLED. ONE OF THE SCREWS WAS NOT FOUND; A SEARCH WAS MADE IN THE TRASH AND CLOTHING TO VERIFY THAT NONE HAD REMAINED IN THE PATIENT. 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 22391636 ↗
• MalfunctionMay 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA AND AFTER THE IMPACTION OF THE GEN II FEMORAL IMPLANT (RIGHT SIZE 6), THE METAL BOLT OF ONE (1) GII FEM LOCK IMPL IMPACTR BROKE AND THE BLACK IMPACTION PART BECOME DETACHED. ALL THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE AS THE FEMORAL IMPLANT WAS STILL IMPLANTED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096535 ↗
• MalfunctionApr 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE BOLT OF A GII FEM LOCK IMPL IMPACTR SHEARED OFF DURING THE IMPACTION OF THE DEFINITIVE FEMORAL COMPONENT. NO PIECES FELL INSIDE OF THE PATIENT, ALL PIECES WERE ACCOUNTED FOR. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 19098508 ↗
• MalfunctionApr 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE CLAW OF A GII FEM LOCK IMPL IMPACTR THAT HOLDS THE IMPLANT HAS BROKEN OFF. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19076965 ↗
• MalfunctionApr 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE GII FEM LOCK IMPL IMPACTR GOT FRACTURED. THE BROKEN PIECE FELL OVER THE SKIN. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19020374 ↗
• MalfunctionFeb 28, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GII FEM LOCK IMPL IMPACTER COULD NOT BE USED, AS THE LEGS WHICH NEED TO OPEN TO PLACE THE IMPLANT ON COULDN'T BE OPENED BY HAND. 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 18801091 ↗
• MalfunctionFeb 28, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GII FEM LOCK INTIMATER COULD NOT BE USED, AS THE LEGS WHICH NEED TO OPEN TO PLACE THE IMPLANT ON COULDN'T BE OPENED BY HAND. 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 18800910 ↗
• MalfunctionSep 30, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING THE SET-UP FOR A TKR SURGERY, A GII FEM LOCK IMPL IMPACTR WAS NOTICED TO BE IN PIECES. THE CENTRAL LOCKING SCREW THAT SECURE THE BLACK BUMPER WAS REMOVED AND IN THE INSTRUMENT TRAY. SURGERY WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15514575 ↗
• MalfunctionSep 8, 2022Degraded; Fracture; Degraded; Fracture

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, THE GII FEM LOCK IMPL IMPACTR PRESENTED WEAR AND TEAR. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED. ALSO, PICTURE PROVIDED SHOW TIP OF ARM IS FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15384886 ↗
• MalfunctionJul 6, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE TRIGGER FINGER PLASTIC OF THE GENESIS II FEMORAL LOCKING IMPLANT IMPACTOR BROKE AWAY DURING IMPACTION OF IMPLANT, DUE TO METAL FATIGUE. NO PIECES FELL INSIDE OF THE PATIENT. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14940482 ↗
• MalfunctionMay 31, 2022Break; Break

  IT WAS REPORTED THAT DURING SURGERY, WHILE DEVICE WAS BEING USED OUTSIDE THE PATIENT, GII FEM LOCK IMPL IMPACT DISMANTLED UPON PLACING THE TRIAL COMPONENT ON THE INTRODUCER. PROCEDURE CONTINUED WITH A BACKUP DEVICE, WITHOUT A DELAY OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14556276 ↗
• InjuryMay 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GII FEM LOCK IMPL IMPACTOR SNAPPED. SURGERY WAS RESUMED, AFTER A DELAY OF LESS THAN 30 MIN, WITH A BACK-UP DEVICE. PATIENT WAS NOT HARMED BEYOND THE ISSUE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14290920 ↗
• MalfunctionApr 23, 2022Positioning Failure; Detachment of Device or Device Component; Positioning Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE GENESIS II FEMORAL LOCKING IMPLANT IMPACTOR IS MISSING AN SCREW, THIS PREVENTS THE DEVICE FROM LOCKING. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14191031 ↗
• MalfunctionApr 11, 2022Break; Break

  IT WAS REPORTED THAT THE GII FEM LOCK IMPL IMPACTR HAD BROKEN. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14074033 ↗
• MalfunctionNov 23, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE METAL ARM OF A GENESIS II FEMORAL LOCKING IMPLANT IMPACTOR SNAPPED. 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 12864107 ↗
• MalfunctionMay 24, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GII FEM LOCK IMPL IMPACTR GOT THE SCREWS OUT. SURGERY WAS RESUMED, WITHOUT ANY SIGNIFICANT DELAY. IT IS UNKNOWN IF THERE WAS ANY AVAILABLE BACK UP DEVICE. NO PATIENT HARM, INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11873064 ↗
• InjuryMay 18, 2021Break; Break

  IT WAS REPORTED THAT DURING TKA SURGERY, THE FIXATION SCREW OF THE GII FEM LOCK IMPL IMPACTR BROKE WHEN PLACING THE FEMUR IMPLANT INSIDE THE PATIENT. A S+N BACK UP DEVICE WAS AVAILABLE. NO INJURY OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11842367 ↗
• MalfunctionApr 20, 2021Break; Break

  IT WAS REPORTED THAT DURING TKA SURGERY, WHILE BEING USED INSIDE THE PATIENT, THE INTERNAL SCREW BROKE ON THE GENESIS II FEMORAL LOCKING IMPLANT IMPACTOR (DID NOT FALL INTO THE PATIENT). NO DELAY REPORTED, THE PROCEDURE WAS ENDED USING A SMITH AND NEPHEW BACK UP DEVICE. NO INJURY TO PATIENT OR OTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693241 ↗
• MalfunctionFeb 3, 2021Break; Break

  IT WAS REPORTED BEFORE THE TKA PROCEDURE THAT THE IMPACTOR WAS BROKEN. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, USING A BACKUP FROM SMITH & NEPHEW. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11276446 ↗
• MalfunctionJan 6, 2021Crack; Crack

  IT WAS REPORTED THAT, A GENESIS II FEM LOCK IMPL IMPACTR WAS NOTICED TO BE DAMAGED. INCIDENT OCCURRED DURING A TKA WITH INSTRUMENTS OUTSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. HOWEVER, AFTER THE DEVICE EVALUATION, IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. 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 11123667 ↗
• MalfunctionDec 13, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE SCREW OF THE IMPACTOR CAME OUT OF SIDE ARM MAKING IT UNUSABLE. INSTRUMENTS WERE OUTSIDE THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO DELAY IN THE SURGERY 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 10999562 ↗
• MalfunctionNov 2, 2020Break; Break

  IT WAS REPORTED THAT DEVICE BROKE BUT IT IS UNKNOWN IF THE EVENT OCCURRED DURING SURGERY. THEREFORE PATIENT INVOLVEMENT CAN NOT BE CONFIRMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10773559 ↗
• MalfunctionNov 2, 2020Break; Break

  IT WAS REPORTED THAT DEVICE BROKE BUT IT IS UNKNOWN IF THE EVENT OCCURRED DURING SURGERY. THEREFORE PATIENT INVOLVEMENT CAN NOT BE CONFIRMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10773405 ↗
• MalfunctionNov 2, 2020Break; Break

  IT WAS REPORTED THAT DEVICE BROKE BUT IT IS UNKNOWN IF THE EVENT OCCURRED DURING SURGERY. THEREFORE PATIENT INVOLVEMENT CAN NOT BE CONFIRMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10773396 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123598. One submission often covers many models, so check the product and lot details in each record.

• Z-0730-2019 · Jan 7, 2019 · Terminated
  SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
• Z-1008-2017 · Nov 16, 2016 · Terminated
  REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116