GENESIS II 71440311Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 03596010462749), received between Feb 22, 2019 and Apr 13, 2026 — classified as 2 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Break” (38 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 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) GII MOD PAT REAMER GDE WAS CROSS THREADED DURING TIGHTENING AND BROKE. 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 24860454 ↗
• MalfunctionNov 16, 2025Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY ONE (1) GII MOD PAT REAMER GDE BROKE DURING IMPACTION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP. NO ADDITIONAL ANESTHETIC WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23565746 ↗
• MalfunctionApr 1, 2025Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT THE SPRING OF ONE (1) GII MOD PAT REAMER GDE WAS BROKEN WHILE BEING USED TO DRILL PATELLA HOLES. THE PROCEDURE WAS PERFORMED, 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 21748811 ↗
• MalfunctionNov 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GOLD NUT OF A GII MOD PAT REAMER GDE UNSCREWED COMPLETELY OFF. 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 20610039 ↗
• MalfunctionMay 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TKA SURGERY, USING A GII MOD PAT REAMER GDE, THE GOLD KNOB SPUN OFF THE TOP AS A RESULT OF A MISSING STOPPING MECHANISM ABOVE THREADS. NO PIECE FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, 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 19408778 ↗
• MalfunctionFeb 1, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TKA SURGERY, A GII MOD PAT REAMER GDE BROKE WHILE CEMENTING PATELLA. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16278118 ↗
• MalfunctionNov 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE TEETH OF THE GII MOD PAT REAMER GDE DEVICE BROKE OFF. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. 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 15875789 ↗
• MalfunctionSep 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE STOPPER AT THE END OF THE GII MOD PAT REAMER GDE, WHERE THE GOLD KNOB IS, BROKE OFF AND FELL ON THE FLOOR. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15412146 ↗
• MalfunctionApr 28, 2022Break; Break

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, WHILE PUTTING A GENESIS II MODIFIED PATELLAR REAMER GUIDE TOGETHER, THE WELDED PIECE STOP AT THE END OF THE THREADED ROD CAME OFF. THIS HAPPENED OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14237054 ↗
• MalfunctionApr 4, 2022Break; Break

  IT WAS REPORTED THAT A PIN OF A GII MOD PAT REAMER GDE HAS BROKEN AND THUS, THE DEVICE NO LONGER FUNCTIONS PROPERLY. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13996171 ↗
• MalfunctionMar 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING SET UP FOR A TKA SURGERY, THE THREADED CYLINDER USED TO SECURE PATELLA CLAMP CAME OFF OF THE GII MOD PAT REAMER GDE ENTIRELY. AS THIS WAS NOTICED BEFORE THE PROCEDURE, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13735679 ↗
• MalfunctionMar 11, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, A PIN OF A GII MOD PAT REAMER GDE BROKE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED, WITH A DELAY OF FEWER THAN 30 MINUTES, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13735421 ↗
• MalfunctionFeb 23, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GII MOD PAT REAMER GDE SCREW STOP BROKE OFF, WHILE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13584282 ↗
• MalfunctionFeb 14, 2022Separation Failure; Separation Failure

  IT WAS REPORTED THAT, DURING SET UP FOR A TKA SURGERY, THE GOLD KNOB ON A GII MOD PAT REAMER GDE CLAMP DISENGAGED AND COULD NOT BE REINSERTED. AS THIS WAS NOTICED UPON SET UP BEFORE THE PROCEDURE, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529702 ↗
• MalfunctionFeb 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PIN FELL OUT OF A GENESIS II MODIFIED PATELLAR REAMER GUIDE. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13470289 ↗
• MalfunctionJan 12, 2022Break; Break

  IT WAS REPORTED THAT DURING A TKA, WHILE THE PHYSICIAN WAS TRYING TO LOOSEN THE CLAMP OF THE GII MOD PAT REAMER GDE, THE GOLD DIAL HAD SCREWED ENTIRELY OFF OF THE THREADS. THEN, THEY NOTICED THAT THE STOPPER ON THE THREADS WAS BROKEN OFF. INCIDENT OCCURRED OUTSIDE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, USING A SMITH AND NEPHEW BACK UP DEVICE. NO INJURY TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13239743 ↗
• MalfunctionDec 15, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GII MOD PAT REAMER GDE BROKE OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13010682 ↗
• MalfunctionDec 2, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING SET UP FOR A TKA SURGERY, WAS NOTICED THE GII MOD PAT REAMER GDE WAS BROKEN. SURGEON WAS NOTIFIED AND AWARE. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12916420 ↗
• MalfunctionNov 18, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PIECE ON END THAT KEEPS THE GOLD KNOB OF A GENESIS II MODIFIED PATELLAR REAMER GUIDE BROKE OFF, NO PIECES FELL INSIDE THE 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 12836262 ↗
• MalfunctionSep 14, 2021Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE SUPPORTING ARM OF A GENESIS II MODIFIED PATELLAR REAMER GUIDE IS BROKEN. IN ADDITION, IT WAS NOTED THAT THE PIN FELL OUT. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12472081 ↗
• MalfunctionSep 2, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, A JRNY II CR LKG FEM IMP BUMPER RT AND A GII MOD PAT REAMER GDE WERE NOTICED TO BE BROKEN. THIS WAS NOTICED AFTER USE IN PATIENT; THEREFORE, PATIENT WAS NO LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12417934 ↗
• InjuryAug 26, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GII MOD PAT REAMER GDE BROKE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE; HOWEVER, PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12372133 ↗
• MalfunctionJul 21, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) GII MOD PAT REAMER GDE BREAK WHILE INSTRUMENTS WERE OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING A SMITH AND NEPHEW BACK-UP DEVICE. NO HEALTH CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12201256 ↗
• MalfunctionJul 14, 2021Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, A GII MOD PAT REAMER GDE BROKE. THIS HAPPENED BEFORE USE IN PATIENT. SURGERY WAS PERFORMED, AFTER A NON-SIGNIFICANT 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 12166315 ↗
• MalfunctionJul 9, 2021Break; Break

  IT WAS REPORTED THAT DURING A TKA A GII MOD PAT REAMER GDE HANDLE BROKE OUTSIDE THE PATIENT DURING SURGERY. NO PIECES FELL INTO PATIENT. SURGERY WAS RESUMED WITH A BACK UP DEVICE, NO SURGICAL DELAY REPORTED. PATIENT STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12143652 ↗

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