GENESIS II 71440044Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 03596010213860), received between Apr 3, 2019 and May 1, 2026 — classified as 7 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Break” (23 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE SCREW AND SPRING OF ONE (1) GII QUICK CONNECT HANDLE FELL OUT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25061852 ↗
• MalfunctionMar 15, 2026Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TKA, THE GII QUICK CONNECT HANDLE BROKE WHEN IT WAS HIT BY THE MALLET. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24601481 ↗
• MalfunctionNov 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE SCREW OF ONE (1) CONNECT HANDLE CAME OUT AND IT CANNOT CONNECT TO TIBIAL BASEPLATE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING 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 18220857 ↗
• MalfunctionJul 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, A GII QUICK CONNECT HANDLE CAME APART WHEN IMPACTED, AND THE LOCKING MECHANISM AND SPRING BECAME LOOSE. ALL PARTS WERE RETRIEVED FROM THE SURGICAL SITE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING 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 17355843 ↗
• MalfunctionJun 13, 2023Fracture; Fracture

  IT WAS REPORTED, THAT DURING A TKA SURGERY. ONE OF THE FIXATION BUMPS ON THE END OF A GII QUICK CONNECT HANDLE BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17117914 ↗
• InjuryOct 25, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE LOCKING TIP OF A GII QUICK CONNECT HANDLE WAS BROKEN WHILE TRYING TO INSERT THE TIBIAL BASEPLATE TRIAL. NO PIECE LEFT IN PATIENT. SURGERY WAS FINISHED WITHOUT ANY DELAY WITH A SN BACK-UP DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15665772 ↗
• MalfunctionMay 27, 2022Break; Break

  IT WAS REPORTED THAT, THE BALL DETENT OF A GII QUICK CONNECT HANDLE IS BROKEN. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14520185 ↗
• MalfunctionMay 15, 2022Break; Break

  IT WAS REPORTED THAT THE TIP OF THE GII QUICK CONNECT HANDLE WAS BROKEN. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14403779 ↗
• MalfunctionApr 9, 2022Break; Positioning Failure; Detachment of Device or Device Component; Naturally Worn; Break; Positioning Failure; Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED THAT A PIECE OF A GENESIS II QUICK CONNECT HANDLE IS BROKEN. IN ADDITION, THE DEVICE DOES NOT ATTACH TO TIBIAL BASEPLATE CORRECTLY. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14068782 ↗
• MalfunctionMar 8, 2022Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT A GENESIS II QUICK CONNECT HANDLE/ALIGNMENT TOWER WAS FOUND BROKEN. THE BUTTON FAILS TO ENGAGE. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13690986 ↗
• MalfunctionMar 4, 2022Break; Break

  IT WAS REPORTED THAT, DURING FIELD INSPECTION, IT WAS FOUND THAT THE GII QUICK CONNECT HANDLE IS BROKEN. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13666513 ↗
• MalfunctionFeb 24, 2022Break; Break

  IT WAS REPORTED THAT A GENESIS II QUICK CONNECT HANDLE/ALIGNMENT TOWER WAS NOTICED TO BE BROKEN. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13592116 ↗
• MalfunctionFeb 14, 2022Break; Break

  IT WAS REPORTED THAT A GENESIS II QUICK CONNECT HANDLE/ALIGNMENT TOWER WAS FOUND TO BE BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529574 ↗
• MalfunctionFeb 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING SET UP FOR A TKA SURGERY, THE PIN OF A GII QUICK CONNECT HANDLE CAME OUT AND NEEDED TO BE REPLACED. AS THIS HAPPENED DURING SET-UP THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13418855 ↗
• MalfunctionJan 3, 2022Break; Break

  IT WAS REPORTED THAT THE GOLD BUTTON OF A GENESIS II QUICK CONNECT HANDLE/ALIGNMENT TOWER IS BROKEN. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13145426 ↗
• MalfunctionDec 28, 2021Break; Break

  IT WAS REPORTED THAT, THE GII QUICK CONNECT HANDLE WAS BROKEN. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13095184 ↗
• MalfunctionDec 21, 2021Break; Break

  IT WAS REPORTED THAT DURING SET UP FOR TKA THE GOLDEN BUTTON SPRING OF THE GII QUICK CONNECT HANDLE BROKE. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO INJURY TO PATIENT OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13056998 ↗
• MalfunctionDec 21, 2021Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT, THE LOCKING BEARING OF THE GII QUICK CONNECT HANDLE HAS A CHIP IN IT PREVENTING IT FROM LOCKING INTO TIBIAL TRIAL. AS THIS WAS NOTICE IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13055023 ↗
• MalfunctionDec 3, 2021Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE BUTTON OF A GII QUICK CONNECT HANDLE BROKE OUTSIDE OF THE PATIENT. IT WAS CONFIRMED THAT NO PIECES FELL INTO PATIENT. 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 12924518 ↗
• MalfunctionNov 19, 2021Break; Failure to Align; Break; Failure to Align

  IT WAS REPORTED THAT, DURING SET-UP/INSPECTION OF A TOTAL KNEE ARTHROPLASTY CASE, A GENESIS II QUICK CONNECT HANDLE/ALIGNMENT TOWER FAILED TO HOLD A TIBIA TRIAL. THE GOLD PART WAS OBSERVED TO BE BROKEN. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12844337 ↗
• MalfunctionNov 9, 2021Break; Connection Problem

  A GII QUICK CONNECT HANDLE WAS REPORTED TO BE BROKEN AS THE DEVICE IS UNABLE TO ACHIEVE CONNECTION. NO CASE INVOLVED, THEREFORE NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12780069 ↗
• MalfunctionSep 16, 2021Break; Break

  IT WAS REPORTED THAT A GII QUICK CONNECT HANDLE IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12485501 ↗
• InjuryAug 13, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA A GII QUICK CONNECT HANDLE WAS BROKEN. SURGERY WAS PERFORMED WITH A BACK UP DEVICES, WITHOUT ANY SURGICAL DELAY. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12320347 ↗
• MalfunctionJul 8, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, DURING A TKA A GII QUICK CONNECT HANDLE DID NOT LOCK ONTO TIBIAL TRAY ANYMORE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12135588 ↗
• MalfunctionJul 7, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A GENESIS II QUICK CONNECT HANDLE/ALIGNMENT TOWER FAILS TO HOLD THE PINS AS EXPECTED. IN ADDITION, IT WAS NOTED THAT A GENESIS II PC P/S CAM MODULE SIZE 5 IS SCRATCHED AND WORN DOWN. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12132293 ↗

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