GENESIS II 71441136Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 03596010484086), received between Jan 28, 2020 and Sep 16, 2024 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Break” (12 reports).

4 other recalls cover devices cleared under the same FDA submission (K121393); 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING TKA SURGERY, THE STOP ON THE TIGHTENING NUT OF THE GII MI IN SLT 3 MO TI CU BL LT BROKE OFF SO THE TIGHTENING NUT FELL OFF. NO PIECES WERE LEFT INSIDE OF THE PATIENT, ALL WERE RECOVERED. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20225583 ↗
• MalfunctionJul 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE SCREW OF THE GII MI IN SLT 3 MO TI CU BL LT BROKE OFF AND IS NOW STUCK ONTO GII TIB ALIGN SPIKED FIX ROD. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19749029 ↗
• MalfunctionJul 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TKA SURGERY, A SCREW FROM ONE (1) GII MI IN SLT 3 MO TI CU BL LT FELL OFF. ALL MATERIALS WERE RECOVERED AND NOTHING WAS LEFT INSIDE OF THE PATIENT. THE PROCEDURE RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697924 ↗
• MalfunctionOct 15, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A PIN OF THE GII MI IN SLT 3 MO TI CU BL LT BROKE OFF IN THE BLOCK. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SMITH AND NEPHEW BACK-UP DEVICE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15612603 ↗
• MalfunctionOct 14, 2022Break; Break

  IT WAS REPORTED THAT, ONE (1) GII MI IN SLT 3 MO TI CU BL LT IS BROKEN. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15610144 ↗
• MalfunctionOct 5, 2022Break; Break

  IT WAS REPORTED THAT A GII MI IN SLT 3 MO TI CU BL LT WAS FOUND BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544150 ↗
• MalfunctionJun 29, 2022Degraded; Fracture; Degraded; Fracture

  IT WAS REPORTED THAT, THE LOCKING MECHANISM OF A GII MI IN SLT 3 MO TI CU BL LT BROKE OFF AND DEVICE IS WORN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14859739 ↗
• MalfunctionJun 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE KNOB OF A GII MI IN SLT 3 MO TI CU BL LT BROKE OFF. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK UP DEVICE. NO PIECES FELL INTO THE PATIENT AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14778052 ↗
• MalfunctionMay 4, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GII INTRA TIB ALIGNMENT AND TWO (2) GII MI IN SLT 3 MO TI CU BL LT MOVED AND WERE LOOSE WHEN FULLY TIGHTENED ON THE TIBIAL TOWER. SURGERY WAS FINISHED, AFTER A DELAY OF 30 MINUTES OR LESS, WITH THE SAME DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14283788 ↗
• MalfunctionMay 4, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GII INTRA TIB ALIGNMENT AND TWO (2) GII MI IN SLT 3 MO TI CU BL LT MOVED AND WERE LOOSE WHEN FULLY TIGHTENED ON THE TIBIAL TOWER. SURGERY WAS FINISHED, AFTER A DELAY OF 30 MINUTES OR LESS, WITH THE SAME DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14283726 ↗
• MalfunctionApr 28, 2022Break; Break

  IT WAS REPORTED THAT, A GII MI IN SLT 3 MO TI CU BL LT- SCREW BROKE IN TIBIAL CUTTING BLOCK WHILE TAKING APART GUIDE AFTER CASE. NO HARM TO PATIENT OR STAFF. ALL PIECES WERE RECOVERED. AS THIS WAS NOTICED AFTER SURGERY, THE PATIENT WAS NO LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14231598 ↗
• MalfunctionMar 14, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE SCREW ON THE GII MI IN SLT 3 MO TI CU BL LT EITHER SHEARED OFF OR STRIPPED OFF THE BLOCK (OUTSIDE THE PATIENT). THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAY. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13758828 ↗
• MalfunctionDec 10, 2021Break; Break

  IT WAS REPORTED THAT, A GII MI IN SLT 3 MO TI CU BL LT WAS FOUND BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12974581 ↗
• MalfunctionDec 10, 2021Break; Defective Device; Break; Defective Device

  IT WAS REPORTED THAT, A GII MI IN SLT 3 MO TI CU BL LT AND A GII NON SPIKE-FIXATION ROD WERE FOUND BROKEN AND DEFECTIVE. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12974555 ↗
• MalfunctionSep 27, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA A GII MI IN SLT 3 MO TI CU BL LT BROKE OFF, NO PIECES FELL INTO THE PATIENT. SURGERY WAS FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE, WITHOUT ANY SURGICAL DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12532410 ↗
• MalfunctionMar 30, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION THE LOCKING THREADS OF THE GENESIS II MI IN SLT 3 MO TITANIUM CU BL LEFT WERE WORN AND IT WAS UNABLE TO LOCK. INCIDENT OCCURRED DURING SET UP OR INSPECTION; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593389 ↗
• MalfunctionMar 25, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, THE THREADS ON THE KNOB OF A GENESIS II MI IN SLT 3 MO TITANIUM CU BL LEFT HAVE BECOME STRIPPED AND CAN NOT LONGER TIGHTEN THE CUT GUIDE TO THE ALIGNMENT TOWER. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572441 ↗
• MalfunctionFeb 2, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A TKA, THE SCRUB TECH NOTICED THAT A PIECE OF THE GII MI IN SLT 3 MO TI CU BL LT FELL APART AFTER COMING THROUGH THE WASH. THE PATIENT WAS NO LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11266960 ↗
• MalfunctionJan 5, 2021Break; Break

  IT WAS REPORTED DURING THE STERILIZATION PROCESS THAT THE SCREW WAS BROKE OFF ON THE TIBIAL CUTTING BLOCK AND GOT LOCKED INTO THE GUIDE. NO PATIENT INVOLVED IN THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11117782 ↗
• MalfunctionDec 5, 2020Break; Break

  IT WAS REPORTED THAT DURING USE, OUTSIDE THE PATIENT, WHILE TIGHTENING THE WHEEL ON THE DRILL GUIDE THE WHEEL SNAPPED OFF. THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10950760 ↗
• MalfunctionNov 26, 2020Break; Connection Problem; Break; Connection Problem

  IT WAS REPORTED THAT DURING TKA PROCEDURE THE GII MI IN SLT 3 MO TI CU BL LT BROKE. THIS HAPPENED OUTSIDE THE PATIENT. NO DELAY. PROCEDURE WAS CONCLUDED WITH A S&N BACK UP DEVICE. NO PIECES FELL INTO PATIENT AND NO INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10911064 ↗
• MalfunctionFeb 5, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT WHEN USING THE DRILL GUIDE, THE SCREW WAS STUCK, SO WHEN THE ALIGNMENT GUIDE WAS REMOVED IT PULLED UPWARD THE PINS IN THE TIBIA. AFTER REMOVING THE ALIGNMENT GUIDE FROM THE DRILL GUIDE, IT WAS NOTICED THAT THE PINS HAD MOVE UPWARDS IN THEIR HOLES, SO THEY WERE LOOSE. THE TIBIA CUT COULDN'T BE DONE PROPERLY SO IT WAS NEEDED TO BE DRILLED TO ACHIEVE THE CUT. DELAY OF 10 MINUTES.

  Patient problems: Injury

  MAUDE report 9671506 ↗
• MalfunctionJan 28, 2020Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT DURING SURGERY, WHEN THE CUT BLOCK WAS TIGHTENED INTO THE TIBIAL GUIDE, THE SET SCREW BROKE LEAVING THE CUT BLOCK AFFIXED TO THE GUIDE AND NOT REMOVABLE UNTIL AFTER THE CASE WITH A PUNCH AND A MALLET. THERE WAS NO DELAY TO THE CASE. THE BROKEN PART WAS OUTSIDE OF THE PATIENT INCISION, IT DIDN'T REPRESENT A POTENTIAL HARM TO THE PATIENT. THE SURGERY WAS NOT AFFECTED AS THE TIBIAL GUIDE COULD STILL BE USED DURING THE CASE JUST FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9639862 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121393. One submission often covers many models, so check the product and lot details in each record.

• Z-0878-2020 · Dec 16, 2019 · Open, Classified
  LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 714344
• Z-0200-2019 · Sep 18, 2018 · Terminated
  Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to mak
• Z-2163-2018 · May 4, 2018 · Terminated
  smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
• Z-1902-2018 · Apr 9, 2018 · Terminated
  smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System Components are indicated for rheumatoid arthritis; post-traumatic a