GENESIS II 71440366Recalls & reported problems

Summary

The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 03596010215192), received between Feb 21, 2019 and Mar 12, 2026 — classified as 9 injuries, 92 malfunctions.

The most frequently reported specific device problem is “Break” (58 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 101 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2026Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PARTS OF ONE (1) GII UNIVERSAL EXTRACTOR SEPARATED. NO PIECES FELL INTO THE PATIENT'S WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE (INSTITUTION'S PLIERS WERE USED). NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24587468 ↗
• MalfunctionFeb 26, 2026Break; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE GII UNIVERSAL EXTRACTOR BROKE WHILE THE PS BOX WAS PREPARING WITH THE IAN ATTACHED TO THE BOX CHISEL. THE PROCEDURE WAS RESUMED, WITHOUT ANY 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 24465718 ↗
• MalfunctionNov 21, 2025Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) GII UNIVERSAL EXTRACTOR BROKE WHERE IT ATTACHES TO THE BOX CHISEL. THE INSTRUMENT BROKE OUTSIDE THE PATIENT. 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 23617190 ↗
• MalfunctionOct 31, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE GII UNIVERSAL EXTRACTOR "SNAPPED" WHEN TAKING OUT BOX CHISEL. ALL PIECES WERE ACCOUNTED FOR, NO PIECES REMAINED IN PATIENT. THEY WERE ALL ACCOUNTED FOR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437886 ↗
• MalfunctionOct 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING TKA, THE WELD OF A GII UNIVERSAL EXTRACTOR FAILED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426836 ↗
• MalfunctionAug 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, WHILE REMOVING THE FEMUR SAMPLE, ONE (1) GII UNIVERSAL EXTRACTOR BROKE. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE, WERE THE SURGEON HAD TO REMOVE THE FEMORAL SAMPLE MANUALLY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE. PATIENT'S CURRENT HEALTH STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22710668 ↗
• MalfunctionJul 13, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING TREATMENT, BIG END OF ONE (1) GII UNIVERSAL EXTRACTOR (SLAP HAMMER) BROKE OFF AND FELL ON THE FLOOR. NO PARTS FELL INTO WOUND AND NO HARM DONE TO PATIENT. TREATMENT WAS RESUMED WITHOUT 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 22491114 ↗
• MalfunctionJul 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, WHEN SURGEON APPLIED THE GII UNIVERSAL EXTRACTOR TO THE SPIKED TIBIAL ROD TO REMOVE AND PROCEEDED TO EXTRACT IT; THE ATTACHMENT FROM THE EXTRACTOR, BROKE OFF. THERE WERE NO PIECES OR FRAGMENTS LANDED IN PATIENT'S ANATOMY. THE TWO PIECES WERE ACCOUNTED FOR AND REMOVED. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22392096 ↗
• MalfunctionJun 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) GII UNIVERSAL EXTRACTOR BROKE OFF. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY; ALSO, IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22355257 ↗
• MalfunctionMay 7, 2025Break; Fracture; Material Deformation; Break; Fracture; Material Deformation

  IT WAS REPORTED THAT ONE (1) GII UNIVERSAL EXTRACTOR BROKE. 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 21976748 ↗
• MalfunctionApr 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) GII UNIVERSAL EXTRACTOR FRACTURED WHILE EXTRACTING, NO PIECES FELL INTO 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 21921013 ↗
• MalfunctionApr 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY THE END OF ONE (1) GII UNIVERSAL EXTRACTOR BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE. ALL PIECES WERE ACCOUNTED FOR AND NO PIECES FELL INSIDE OF PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21828640 ↗
• MalfunctionMar 26, 2025Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE END OF ONE (1) GII UNIVERSAL EXTRACTOR BROKE OFF. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO INJURY OR DELAY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697248 ↗
• MalfunctionFeb 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, A LARGE END OF A (1) GII UNIVERSAL EXTRACTOR BROKE OFF. 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 21446059 ↗
• MalfunctionNov 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, THE END OF ONE (1) GII UNIVERSAL EXTRACTOR BROKE OFF WHEN REMOVING A FEMORAL TRIAL. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20723143 ↗
• MalfunctionSep 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING TKA SURGERY, A GII UNIVERSAL EXTRACTOR BROKE AT END OF CASE. THE PROCEDURE WAS COMPLETED AFTER A NON-SIGNIFICANT 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 20225602 ↗
• MalfunctionSep 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GII UNIVERSAL EXTRACTOR BROKE WHILE BEING USED TO REMOVE 5-1 BLOCK. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT'S HEALTH STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146788 ↗
• MalfunctionAug 29, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, AN END OF ONE (1) GII UNIVERSAL EXTRACTOR FEEL OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20102318 ↗
• MalfunctionJul 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE GII UNIVERSAL EXTRACTOR BROKE. NO PIECES FELL INSIDE PATIENT. 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 19643924 ↗
• MalfunctionMay 27, 2024Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, IT WAS NOTICED THAT ONE (1) UNIVERSAL EXTRACTOR BROKE IN SURGERY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, IT IS UNKNOWN HOW THE PROBLEM WAS SOLVED. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19400811 ↗
• MalfunctionMar 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, THE TIP OF ONE (1) GII UNIVERSAL EXTRACTOR BROKE. THE TIP WAS REMOVED USING FORCEPS. 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 18937804 ↗
• MalfunctionMar 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE END OF GII UNIVERSAL EXTRACTOR BROKE OFF. 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 18925365 ↗
• MalfunctionMar 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, IT WAS NOTICED THAT THE END OF ONE (1) GII UNIVERSAL EXTRACTOR BROKE OFF. IT IS UNKNOWN HOW THE PROCEDURE FINISHED. NO DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18849378 ↗
• MalfunctionFeb 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING TKA SURGERY, THE SLAP HAMMER OF A GII UNIVERSAL EXTRACTOR BROKE DURING CASE. SURGERY WAS PERFORMED WITHOUT ANY DELAY WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18636060 ↗
• MalfunctionJan 31, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, IT WAS NOTICED THAT THE CAPTURE END OF ONE (1) GII UNIVERSAL EXTRACTOR BROKE OFF DURING EXTRACTION. 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 18618877 ↗

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