GENESIS II 71440009Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00885556034736), received between Feb 6, 2019 and Apr 28, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Fracture” (12 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN ONE (1) FEMORAL TRIAL IMPACTOR WAS BEING REMOVED, AFTER PLACEMENT OF THE TRIAL FEMUR, IT FELL APART INTO TWO PIECES IN THE DOCTOR'S HAND. THE PROCEDURE WAS RESUMED, 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 25024053 ↗
• MalfunctionFeb 3, 2026Break; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) FEMORAL TRIAL IMPACTOR BROKE WHILE IMPACTING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245070 ↗
• MalfunctionMay 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY ONE (1) FEMORAL TRIAL IMPACTOR BROKE WHILE IMPACTING TRIAL FEMUR. 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 22105091 ↗
• MalfunctionNov 25, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, THE METAL PART THAT HOLDS THE TRIAL ON A FEMORAL TRIAL IMPACTOR BROKE OFF. THERE WAS A NO-NSIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20772458 ↗
• MalfunctionSep 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, A FEMORAL TRIAL IMPACTOR BROKE WHILE TRIALING. THE PROCEDURE WAS RESUMED, USING A S+N BACK-UP DEVICE. IT IS UNKNOWN IF A DELAY OCCURRED DUE TO THIS EVENT. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20225079 ↗
• MalfunctionFeb 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE CENTRAL PIECE OF ONE (1) FEMORAL TRIAL IMPACTOR 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 18707164 ↗
• MalfunctionOct 18, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING IMPACTION OF FEMORAL TRIAL IMPACTOR, BLACK PLASTIC EDGE OF IMPACTOR BROKE OFF AND A SLIVER OF IT WAS IMBEDDED IN SURGEON'S FINGER THROUGH BOTH SURGICAL GLOVES. THE SURGEON PERFORMED ALL APPROPRIATE ACTIONS TO ADDRESS THE PUNCTURE BEFORE PERFORMING A NEW SURGICAL SCRUB AND RESUME SURGERY. THE PLASTIC SLIVER IMBEDDED INTO SURGEON'S FINGER; IT WAS REMOVED WITHOUT INJURY. NONE OF THE FRAYED PLASTIC ENTERED THE PATIENT; HOWEVER, AS A PRECAUTION, THE WOUND WAS COPIOUSLY IRRIGATED. 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: Needle Stick/Puncture

  MAUDE report 17958321 ↗
• MalfunctionJul 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE FEMORAL TRIAL IMPACTOR BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, BUT IT IS UNKNOWN HOW. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17248884 ↗
• MalfunctionApr 4, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A FEMORAL TRIAL IMPACTOR BROKE UPON IMPACTION OF THE TRIAL FEMUR. IT IS UNKNOWN HOW SURGERY WAS FINISHED AND IF THIS INCIDENT CAUSED ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16678469 ↗
• MalfunctionOct 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, THE METAL PIECE ON THE FEMORAL TRIAL IMPACTOR WAS FALLING OFF. SINCE INCIDENT OCCURRED DURING DEVICE REPROCESSING; PATIENT WAS NO LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15590968 ↗
• MalfunctionSep 30, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE METAL PIECE IN THE MIDDLE OF A FEMORAL TRIAL IMPACTOR BROKE OFF. 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 15519093 ↗
• MalfunctionMar 1, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING THE SET UP FOR A TKA SURGERY, THE HANDLE OF A FEMORAL TRIAL IMPACTOR BROKE OFF. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13639290 ↗
• MalfunctionJan 6, 2022Break; Break

  IT WAS REPORTED THAT DURING SET UP FOR A TKA SURGERY, THE BLACK TIP OF THE FEMORAL TRIAL IMPACTOR BROKE OFF OF HANDLE. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13181874 ↗
• MalfunctionJul 13, 2021Break; Break

  IT WAS REPORTED THAT, THE SILVER PART OF THE FEMORAL TRIAL IMPACTOR WAS BROKEN. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12164323 ↗
• MalfunctionMay 24, 2021Break; Break

  IT WAS REPORTED THAT, A FEMORAL TRIAL IMPACTOR IS BROKEN. AS THIS WAS NOTICED DURING INSPECTION IN CENTRAL STERILE, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11873200 ↗
• MalfunctionFeb 5, 2021Break; Break

  IT WAS REPORTED THAT AFTER USING IMPACTOR AND UNLATCHING IT FROM THE FEMORAL TRIAL IT FELL A PART. NO SURGICAL DELAY. UNKNOWN HOW THE PROCEDURE FINISHED. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11284791 ↗
• MalfunctionDec 2, 2020Break; Break

  IT WAS REPORTED THAT, UPON INSPECTION OF INSTRUMENTS BEFORE A TKA, THE FEMORAL TRIAL IMPACTOR WAS FOUND BROKEN. S&N BACKUP WAS AVAILABLE TO PERFORM THE SURGERY WITHOUT DELAY. PATIENT WAS NOT IMPACTED BY THE ALLEGED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10937035 ↗
• MalfunctionJul 28, 2020Break; Break

  IT WAS REPORTED THAT THE IMPACTOR WAS FOUND TO BE BROKEN IN THE TRAY WHEN IT WAS ABOUT TO BE USED FOR THE TKA PROCEDURE. THERE WAS A REPLACEMENT INSTRUMENT PEAL PACKED AND IT WAS USED TO COMPLETE THE SURGERY. NO DELAY. NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10336077 ↗
• MalfunctionDec 5, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE INSTRUMENT BROKE. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9419820 ↗
• MalfunctionApr 15, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, DEVICE BROKE. IT DID NOT BREAK ABOVE THE INCISION AND NO PIECES FELL INTO THE PATIENT. NO INJURY REPORTED. NO DELAY REPORTED. SURGERY WAS COMPLETED BY HAND.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8512787 ↗
• MalfunctionFeb 6, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, METAL PIECE THAT ATTACHES TO TRIAL BROKE OFF. NO DELAY, HAD BACKUP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8310893 ↗

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