GENESIS II 71440005Recalls & reported problems

Summary

The FDA's MAUDE database contains 599 adverse event reports that list this exact device (DI 00885556034156), received between Feb 2, 2018 and May 27, 2026 — classified as 34 injuries, 565 malfunctions.

The most frequently reported specific device problem is “Break” (306 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 599 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA, THE GREEN PLASTIC OF ONE (1) FEMORAL IMPLANT IMPACTOR BROKE OFF. NOTHING FELL INSIDE THE WOUND. 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 25311017 ↗
• MalfunctionMay 25, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GREEN PIECE ON THE SPRING OF (1) OF THE FEMORAL IMPLANT IMPACTOR BROKE OFF. 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 25273376 ↗
• MalfunctionMay 18, 2026Degraded; Fracture

  IT WAS REPORTED THAT, DURING A TKR SURGERY, THE BLACK PLASTIC BUMPER OF ONE (1) FEMORAL IMPLANT IMPACTOR WAS FRACTURED AND FATIGUE. THE PIECE WAS COMPLETED AND NOTHING WAS LEFT IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25203531 ↗
• MalfunctionApr 28, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE TIP OF ONE (1) FEMORAL IMPLANT IMPACTOR BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, OR IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020418 ↗
• MalfunctionMar 17, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN GOING TO IMPACT THE FEMUR, IT WAS NOTICED THAT THE FEMORAL IMPLANT IMPACTOR WAS STARTING TO SPLIT. THEN, IT SPLIT COMPLETELY WHILE IMPLANTING. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621848 ↗
• MalfunctionFeb 24, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GREEN BUMPER OF ONE (1) FEMORAL IMPLANT IMPACTOR SNAPPED WHILE IMPACTING A FEMORAL IMPLANT. ALL PARTS WERE RETRIEVED BY HAND, VERIFIED BY PLACING THE TWO PIECES TOGETHER TO FORM A COMPLETE BUMPER. 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 24428346 ↗
• MalfunctionJan 27, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, AFTER IMPACTING THE FEMUR AND WHILE REMOVING THE IMPACTOR, THE GREEN TIP OF ONE (1) FEMORAL IMPLANT IMPACTOR BROKE. AS SOON AS THE PIECE BROKE, THE FRAGMENT FELL TO THE FLOOR. THE PROCEDURE HAD BEEN COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24188585 ↗
• MalfunctionDec 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PLASTIC PIECE OF THE FEMORAL IMPLANT IMPACTOR BROKE OFF. NO PIECE FELL INSIDE PATIENT. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH THE SAME REPORTED PRODUCT. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23897587 ↗
• MalfunctionDec 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE GREEN TIP OF A FEMORAL IMPLANT IMPACTOR BROKE OFF DURING IMPLANTATION. FRAGMENTS WERE RETRIEVED. 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 23705141 ↗
• MalfunctionNov 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN THE FINAL FEMORAL IMPLANT WAS PLACED, ONE (1) FEMORAL IMPLANT IMPACTOR BROKE. THEY WERE ABLE TO PLACE THE IMPLANT IN THE IMPACTOR AND INSERT IT INTO THE PATIENT, BUT IT WAS A BIT LOOSE. 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 23513244 ↗
• MalfunctionNov 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE RESIN AND/OR PLASTIC PART OF ONE (1) FEMORAL IMPLANT IMPACTOR BROKE UPON IMPACT WITH THE FEMUR. PIECES WERE REMOVED WITH A KELLY CLAMP. 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 23502091 ↗
• MalfunctionSep 8, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE TIP OF ONE (1) FEMORAL IMPLANT IMPACTOR BROKE DURING IMPLANT PLACEMENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. IT IS UNKNOWN HOW SURGERY WAS COMPLETED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22994916 ↗
• MalfunctionAug 22, 2025Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GREEN PIECE OF ONE (1) FEMORAL IMPLANT IMPACTOR BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO DELAY OR INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22870253 ↗
• MalfunctionJul 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, ONE (1) FEMORAL IMPLANT IMPACTOR BROKE WHILE IMPLANTING THE FINAL IMPLANT. 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 22644444 ↗
• MalfunctionJul 24, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GREEN PART OF ONE (1) FEMORAL IMPLANT IMPACTOR BROKE IN A SMALL PIECE. THE SURGEON REMOVED THE GREEN PIECE FROM INSIDE THE PATIENT WITH A TWEEZER. ALL PIECES ACCOUNTED FOR. 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 22602021 ↗
• MalfunctionJun 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING TKA SURGERY THE GREEN PLASTIC OF ONE (1) FEMORAL IMPLANT IMPACTOR BROKE OFF DURING IMPLANTATION. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235193 ↗
• MalfunctionMay 9, 2025Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE HANDLE OF ONE (1) FEMORAL IMPLANT IMPACTOR BROKE WHILE USING IT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO DELAY AND NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993997 ↗
• MalfunctionApr 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE LOCK WASHER ON ONE (1) FEMORAL IMPLANT IMPACTOR BROKE. 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 21932447 ↗
• MalfunctionApr 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY ONE (1) FEMORAL IMPLANT IMPACTOR TIP BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED OR IF THERE WAS ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21931653 ↗
• MalfunctionApr 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE OF THE PLASTIC PIECES OF ONE (1) FEMORAL IMPLANT IMPACTOR BROKE OFF WHILE INSERTING THE FEMUR. ALL PIECES WERE RETRIEVED BY HAND, BUT NOTHING FELL INTO THE PATIENT'S 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 21896433 ↗
• MalfunctionApr 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, THE TIP OF THE GII SHORT I/M ROD 8 INCH, BROKE OFF. IT IS UNKNOWN IF THE PIECE FELL INSIDE PATIENT'S ANATOMY. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21895137 ↗
• MalfunctionApr 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, THE GREEN PIECE OF THREE (3) FEMORAL IMPLANT IMPACTOR, BROKE OFF. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. IT IS UNKNOWN HOW PROCEDURE WAS FINISHED AND IF THERE WAS ANY DELAY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21819969 ↗
• MalfunctionMar 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GREEN PIECE OF ONE (1) FEMORAL IMPLANT IMPACTOR BROKE OFF WHILE IMPACTING THE FEMUR. NO PIECES WERE LEFT INSIDE 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 21692873 ↗
• MalfunctionFeb 20, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN TRYING TO PLACE THE TIBIAL GUIDE IN THE PATIENT, ONE (1) ORTHOMATCH ANKLE CLAMP BROKE AND ONE (1) FEMORAL IMPLANT IMPACTOR BROKE WHEN IMPACTING THE FEMORAL COMPONENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING S+N BACK-UP DEVICES. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21420141 ↗
• MalfunctionJan 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GREEN BUMPER OF ONE (1) FEMORAL IMPLANT IMPACTOR BROKE WHILE IMPACTING THE FEMORAL IMPLANT. 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 21164713 ↗

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