GENESIS II 71440194Recalls & reported problems

Summary

The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 03596010214393), received between Feb 9, 2018 and May 25, 2026 — classified as 18 injuries, 96 malfunctions.

The most frequently reported specific device problem is “Break” (50 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 25 most recent of 114 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 25, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKR, THE END OF ONE (1) GII ARTICULAR INSERTER/EXTRACT SNAPPED OFF DURING POLY/INSERT INSERTION INTO THE GEN II BASEPLATE. 1 PIECE FELL INSIDE THE WOUND AND WAS REMOVED AND ACCOUNTED WITH FORCEPS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25273347 ↗
• MalfunctionMay 3, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA, A SMALL PLASTIC PART THAT GRIPS THE IMPLANT OF ONE (1) GII ARTICULAR INSERTER/EXTRACT SNAPPED OFF. NO FRAGMENTS FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062983 ↗
• MalfunctionApr 26, 2026Fracture

  IT WAS REPORTED THAT, DURING LEGION TKA SURGERY, THE SURGEON USED THE GII ARTICULAR INSERTER/EXTRACT TO INSERT THE POLY LINER IMPLANT, BUT IT SNAPPED DURING USAGE. THE SNAPPED PIECE WAS LOCATED FROM INSIDE THE PATIENT AND CONFIRMED NOTHING WAS LEFT INSIDE. NO INCORRECT USAGE OR EXCESSIVE FORCE USED. NO INJURY NOR ADDITIONAL BONE/TISSUE REMOVAL REQUIRED, AND SNAPPED PIECE WAS RETRIEVED USING FORCEPS. SURGEON WAS FAMILIAR WITH THE ITEM AND HAS USED IT BEFORE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24993858 ↗
• MalfunctionMar 30, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE TIP OF THE GII ARTICULAR INSERTER/EXTRACT BROKE OFF WHEN PUTTING THE REAL POLY IN. ALL PIECES WERE FOUND, AND NOTHING WAS LOST IN THE PATIENT. NO ADDITIONAL ANESTHESIA WAS REQUIRED. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24720159 ↗
• MalfunctionMar 7, 2026Fracture

  IT WAS REPORTED THAT DURING A TKA, THE TIP OF A GII ARTICULAR INSERTER/EXTRACT BROKE. NO PIECES FELL INTO PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24541542 ↗
• MalfunctionFeb 22, 2026Break

  IT WAS REPORTED THAT DURING A TKA SURGERY, TWO (2) GII ARTICULAR INSERTER/EXTRACT BROKE WHEN IT WAS TRYING TO INSERT THE POLY. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24410870 ↗
• MalfunctionFeb 9, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE END OF ONE (1) GII ARTICULAR INSERTER/EXTRACT, BROKE OFF WHEN PLACING THE POLY. 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 24300488 ↗
• MalfunctionJan 7, 2026Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE TIP OF ONE (1) GII ARTICULAR INSERTER/EXTRACT CHIPPED WHILE ATTEMPTING TO SEAT THE POLYETHYLENE INSERT. THEY WERE ABLE TO RETRIEVE THE BROKEN PIECE FROM THE PATIENT. THIS WAS CONFIRMED WITH X-RAYS. THE PROCEDURE WAS COMPLETED, AFTER NO DELAY, USING AN EQUIVALENT S+N BACK UP. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989218 ↗
• MalfunctionDec 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE FRONT PART/NOSE OF ONE (1) GII ARTICULAR INSERTER/EXTRACT BROKE DURING THE INSERTION OF THE INSERT. THE SURGERY TEAM FOUND THE BROKEN-OFF METAL FRAGMENT IN THE SUCTION CANISTER. BROKEN PIECE WAS RETRIEVED BY SUCTION AND ACCOUNTED FOR. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT CURRENT HEALTH STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816387 ↗
• MalfunctionDec 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, WHILE USING ONE (1) GII ARTICULAR INSERTER/EXTRACT TO POSITION THE FINAL INSERT, IT FRACTURED. NO PIECE FELL INSIDE THE WOUND. THE PROCEDURE WAS COMPLETED, AFTER NO DELAY, USING THE SAME S+N PRODUCT. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803203 ↗
• MalfunctionOct 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY THE TIP OF ONE (1) GII ARTICULAR INSERTER/EXTRACT BROKE OFF. THE BROKEN PIECE WAS PRESUMABLY TO HAVE BEEN COLLECTED VIA SUCTION. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY WITH AN EQUIVALENT S+N BACK UP PRODUCT DEVICE. NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23364457 ↗
• MalfunctionOct 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, ONE (1) GII ARTICULAR INSERTER/EXTRACT BROKE DURING THE CASE. IT IS UNKNOWN IF ANY PIECE FELL INSIDE PATIENT'S ANATOMY. 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 23364102 ↗
• MalfunctionOct 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, WHEN POSITIONING THE INSERT, THE GII ARTICULAR INSERTER/EXTRACT BROKE IN THE TIP. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. THE PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336891 ↗
• MalfunctionSep 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY ONE (1) GII ARTICULAR INSERTER/EXTRACT CHIPPED OFF WHILE THEY WERE SEATING THE POLY. NO PIECES FELL INSIDE 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 23005182 ↗
• MalfunctionJul 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE TIP OF ONE (1) GII ARTICULAR INSERTER/EXTRACT BROKE OFF AND WAS RETRIEVED USING TWEEZERS. NO ADDITIONAL DOCUMENTS WERE OBTAINED, AND NO IMAGING WAS REQUIRED TO CONFIRM PIECES WERE INSIDE THE PATIENT. 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 22480226 ↗
• MalfunctionMay 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A REVISION SURGERY OF A TKR, ONE (1) GII ARTICULAR INSERTER/EXTRACT BROKE WHILE BEING USED TO REMOVED THE ORIGINAL POLY FROM THE TIBIAL BASE PLATE. NO METAL WAS LEFT IN THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A COMPETITOR DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21950269 ↗
• MalfunctionApr 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA, WHEN INSERTING ONE (1) GII ARTICULAR INSERTER/EXTRACT THAT WAS ALREADY BENT, IT BROKE. ALL THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT WITH SUCTION. 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 21933918 ↗
• MalfunctionApr 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE TIP OF ONE (1) GII ARTICULAR INSERTER/EXTRACT BROKE WHEN THE INSERT WAS INSERTED. 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 21899134 ↗
• MalfunctionApr 8, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE TIPS OF THE LEVERS OF TWO (2) GII ARTICULAR INSERTER/EXTRACT BROKE OFF. ONE OF THE TIPS WAS ALREADY BROKEN PRIOR TO THE START OF THE CASE, WHILE THE SECOND TIP BROKE DURING THE PROCEDURE. 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 21802156 ↗
• MalfunctionFeb 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GII ARTICULAR INSERTER/EXTRACT WAS BENT AND THEREFORE WOULD NOT INSERT THE POLY. AN ALTERNATIVE GII ARTICULAR INSERTER/EXTRACT WAS USED, WHICH BROKE WHEN LEVERED AGAINST THE POLY. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A CHANGE IN THE SURGICAL TECHNIQUE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21341260 ↗
• MalfunctionFeb 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING POLY INSERTION THE TIP OF A GII ARTICULAR INSERTER/EXTRACT BROKE OFF. THE PIECE WAS RETRIEVED, BUT IT IS UNKNOWN HOW. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE. IT IS UNKNOWN HOW WAS THE PROCEDURE FINISHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21313789 ↗
• MalfunctionJan 16, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A TKA, SURGEON WENT TO INSERT POLY, HOWEVER, HE HAD DIFFICULTY DUE TO A CHIP ON THE END OF THE GII ARTICULAR INSERTER/EXTRACT. NEVERTHELESS, HE WAS ABLE TO GET IT INSERTED. SURGEON WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21167391 ↗
• MalfunctionDec 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE TIP OF THE GII ARTICULAR INSERTER/EXTRACT BROKE OFF DURING USE. THE PROCEDURE WAS PERFORMED, AFTER NO 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 20854228 ↗
• MalfunctionNov 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, WHEN ONE (1) GII ARTICULAR INSERTER/EXTRACT WOULD NOT ATTACH TO SEAT THE POLY, IT WAS NOTICED THAT THE TIP HAD BROKEN OFF AND WAS SITTING ON THE TOP OF THE BASE PLACE. THE BROKEN PIECE WAS TAKEN OUT OF THE JOINT, NOTHING WAS LEFT IN THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20649560 ↗
• MalfunctionOct 24, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE GII ARTICULAR INSERTER/EXTRACT CHIPPED WHILE LOCKING IN THE POLY. ALL PIECES WERE FOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN THE SURGICAL TECHNIQUE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20529074 ↗

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