GENESIS II 71441553Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 03596010497369), received between Jan 4, 2019 and Feb 21, 2026 — classified as 1 injury, 35 malfunctions.

The most frequently reported specific device problem is “Break” (17 reports).

2 other recalls cover devices cleared under the same FDA submission (K123598); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2026Fracture

  IT WAS REPORTED THAT, THE HEAD OF A GII PS HIGH FLEX IMPCTR HD 1-2 BROKE AS DOCTOR INSERTED POLY. IT JUST SNAPPED OFF. NOTHING FELL INSIDE THE PATIENT AND NO FRAGMENTS ARE IN 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 24410356 ↗
• MalfunctionFeb 3, 2026Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY ONE (1) GII PS HIGH FLEX IMPCTR HD 1-2 BROKE WHILE IMPLANTING THE POLY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP DEVICE. THE SURGERY WENT PERFECTLY. NO FURTHER COMPLICATIONS OR HARM WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245049 ↗
• MalfunctionNov 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PLASTIC OF ONE (1) GII PS HIGH FLEX IMPCTR HD 1 2 BROKE DURING STANDARD USAGE. NO PIECES FELL INSIDE PATIENT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632934 ↗
• MalfunctionApr 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, WHILE IMPACTING ONE (1) GII PS HIGH FLEX IMPCTR HD 1-2, THE POST BROKE OFF. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL 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 21930197 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE TIP OF ONE (1) GII PS HIGH FLEX IMPCTR HD 1-2 BROKE OFF WHILE IMPACTING THE INSERT. THE PROCEDURE WAS RESUMED, WITHOUT ANY SURGICAL 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 21920557 ↗
• MalfunctionApr 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, WHILE IMPACTING ONE (1) GII PS HIGH FLEX IMPCTR HD 1-2 THE POST 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 21915666 ↗
• MalfunctionMar 31, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PLASTIC BUMPER OF ONE (1) GII PS HIGH FLEX IMPCTR HD 1-2 BROKE INTO 2 PIECES. BOTH PIECES WERE RECOVERED AND NOTHING ELSE WAS NEEDED TO COMPLETE THE CASE. SPACER WAS LOCKED. 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 21731334 ↗
• MalfunctionSep 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, ON IMPACTION, THE POST ON BOTTOM OF GII PS HIGH FLEX IMPCTR HD 1-2, BROKE OFF. ALL PIECES RETRIEVED. NOTHING WAS LEFT IN PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. THERE WAS NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20286463 ↗
• MalfunctionAug 7, 2024Break; Break

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE GII PS HIGH FLEX IMPCTR HD 1-2 BROKE WHEN USING IT FOR THE FINAL POLY IMPLANT. 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 19933953 ↗
• MalfunctionJul 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, WHILE IMPACTING A POLY INSERT, THE BLACK PLASTIC TIP OF THE GII PS HIGH FLEX IMPCTR HD 1-2 BROKE OFF. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, CHANGING SURGICAL TECHNIQUE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19785549 ↗
• MalfunctionJun 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, THE GII PS HIGH FLEX IMPCTR HD 1-2 BROKE DURING IMPLANTATION. NOTHING WAS INSIDE THE WOUND. 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 19558119 ↗
• MalfunctionApr 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE BLACK TIP OF THE HIGH FLEX POLY INSERTER BROKE WHILE INSERTING THE FINAL IMPLANT. ALL PIECES WERE FOUND AND REMOVED FROM THE FIELD. 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 19033131 ↗
• MalfunctionDec 5, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN THE PHYSICIAN WENT TO IMPACT POLY, THE TIP OF ONE (1) GII PS HIGH FLEX IMPCTR HD 1-2 P BROKE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 18271470 ↗
• MalfunctionNov 24, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GII PS HIGH FLEX IMPCTR HD 1-2 BROKE OFF UPON POLY IMPACTION. ALL PIECES WERE RECOVERED. 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 18204333 ↗
• MalfunctionNov 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, A GII PS HIGH FLEX IMPCTR HD 1-2 BROKE ON THE TOP BLACK PLASTIC PIECE. ADDITIONALLY, NO PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, AFTER A (3) THREE MINUTE DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18066221 ↗
• MalfunctionSep 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, THE HEAD OF A GII PS HIGH FLEX IMPCTR HD 1-2 BROKE OFF WHILE IMPACTING THE POLY. THE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17785732 ↗
• MalfunctionApr 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) GII PS HIGH FLEX IMPCTR HD 1-2 TIP BROKE WHILE IMPLANTING THE POLY. THERE WEREN'T ANY PIECES BROKEN INSIDE THE PATIENT AFTER FURTHER EVALUATION OF THE SURGEON. THE WOUND WAS WASHED OUT THOROUGHLY JUST IN CASE. ALL PIECES WERE FOUND AND RETURNED. 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 16825747 ↗
• MalfunctionOct 4, 2022Fracture; Fracture

  IT WAS REPORTED THAT, THE STEM OF A GII PS HIGH FLEX IMPCTR HD 1-2 BROKE OFF IN THE METAL HANDLE. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15535491 ↗
• MalfunctionAug 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE BACK SIDE OF THE GII PS HIGH FLEX IMPCTR HD 1-2 WAS FOUND BROKEN. AS THIS WAS NOTICED IN A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15267003 ↗
• MalfunctionAug 17, 2022Fracture; Fracture

  IT WAS REPORTED THAT, UPON REMOVAL FROM HANDLE, THE STEM ON A GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT IMPACTOR HEAD SIZE 1-2 BROKE OFF. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15243127 ↗
• MalfunctionMay 27, 2022Break; Break

  IT WAS REPORTED THAT AFTER A TKA SURGERY THE GII PS HIGH FLEX IMPCTR HD 1-2 BROKE. THE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, AS THEY DID NO LONGER NEED THE DEVICE SINCE THE MALFUNCTION WAS NOTICED AFTER SURGERY THE PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14520234 ↗
• MalfunctionMay 25, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING TKA SURGERY, A GII PS HIGH FLEX IMPCTR HD 1-2 PIECES CHIPPED ON IMPACTION. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14502000 ↗
• InjuryMay 21, 2022Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE END OF GII PS HIGH FLEX IMPCTR HD 1-2 BROKE OFF ON IMPACTION. ALL PIECES WERE RETRIEVED. DEVICE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14466715 ↗
• MalfunctionJun 22, 2021Break; Break

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY. A LEGION TKS HIGH FLEX IMPACTOR HEAD (SIZE 1-2) BROKE OUTSIDE THE PATIENT. 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 12042944 ↗
• MalfunctionJun 22, 2021Break; Break

  IT WAS REPORTED THAT DURING A TKA SURGERY, A HI-FLEX IMPACTOR HEAD SIZE 1-2 BROKE OUTSIDE THE PATIENT. SURGERY WAS COMPLETED, WITHOUT DELAY, BY USING A BACK-UP DEVICE. THE PATIENT WAS NOT HARMED BEYOND WHAT HAS BEEN DESCRIBED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12042924 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123598. One submission often covers many models, so check the product and lot details in each record.

• Z-0730-2019 · Jan 7, 2019 · Terminated
  SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
• Z-1008-2017 · Nov 16, 2016 · Terminated
  REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116