GENESIS II 71440895Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 03596010592767), received between Feb 5, 2019 and Sep 25, 2025 — classified as 1 injury, 39 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY THE LOCKING SCREW OF ONE (1) GII UNIV PS FEMORAL IMPACTOR BROKE, PART OF IT FELL ON THE FLOOR AND WAS RETRIEVED. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23152008 ↗
• MalfunctionAug 13, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN THE DEFINITIVE FEMUR WAS BEING IMPACTED, THE PLASTIC EDGE OF THE GII UNIV PS FEMORAL IMPACTOR, BROKE. THE BROKEN PART WAS TAKEN AND VERIFIED THAT THERE WAS NOTHING IN THE PATIENT. 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 22801085 ↗
• MalfunctionJun 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE SPRING OF ONE (1) GII UNIV PS FEMORAL IMPACTOR WAS RELEASED. THE PROCEDURE WAS PERFORMED, 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 22235079 ↗
• MalfunctionAug 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, THE PLASTIC ON THE HOOK OF A GENESIS II UNIVERSAL PS FEMORAL IMPACTOR BROKE OFF IN THE PART THAT LATCHES ONTO FEMUR USING THE TRIGGER. ONE PIECE OF THE BROKEN DEVICE FELL INTO PATIENT AND WAS RETRIEVED BY HAND. 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 19961455 ↗
• MalfunctionAug 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, THE GII UNIV PS FEMORAL IMPACTOR TIP BROKE IN HALF AND WAS FULLY ACCOUNTED. NO PIECES FELL INTO PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19907242 ↗
• MalfunctionMay 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GII UNIV PS FEMORAL IMPACTOR BROKE WHILE PUTTING ON THE FINAL TRIAL. ALL PIECES WERE RECOVERED HAS SHOWN IN THE ABOVE PICTURE. 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 19377197 ↗
• MalfunctionMar 25, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA, WHEN TRAILING THE FEMUR, THE SCREW OF ONE (1) GII UNIV PS FEMORAL IMPACTOR SNAPPED OFF. THE PIECE WAS RETRIEVED USING FORCEPS. 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 18975644 ↗
• MalfunctionAug 1, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) GII UNIV PS FEMORAL IMPACTOR WAS BROKEN/FRACTURE OUTSIDE OF THE PATIENT. THERE WAS A RING COME OFF OF IT AND THE GREEN PLASTIC PART WAS BROKEN ALSO. 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 17439647 ↗
• MalfunctionJul 7, 2022Detachment of Device or Device Component; Mechanics Altered; Detachment of Device or Device Component; Mechanics Altered

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A COMPONENT WITHIN THE SPRING MECHANISM OF A GENESIS II UNIVERSAL PS FEMORAL IMPACTOR BROKE LOOSE AND THE THUMB SCREW CANNOT BE TIGHTENED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SN BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14952071 ↗
• MalfunctionJun 25, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GENESIS II UNIVERSAL PS FEMORAL IMPACTOR DID NOT FIX ON THE IMPLANT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. UPON VISUAL INSPECTION, IT WAS FOUND THAT THE GREEN CAM ARMS WERE BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14819133 ↗
• MalfunctionJun 10, 2022Fracture; Fracture

  IT WAS REPORTED THAT, (8) LID FOR OUTER CASES, A GII SPC P/S HOUS COLLET S 3-8 AND A GII UNIV PS FEMORAL IMPACTOR WERE BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655122 ↗
• MalfunctionJun 8, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN IMPACTING THE FEMORAL COMPONENT, THE GREEN SHIELD OF THE GII UNIV PS FEMORAL IMPACTOR BROKE. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING THE SAME DEVICE. PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14639610 ↗
• MalfunctionMay 6, 2022Crack; Crack

  IT WAS REPORTED THAT, AFTER GOING THROUGH THE WASHER, IT WAS NOTICED THAT THE GII UNIV PS FEMORAL IMPACTOR HAS A CRACK ON IT. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14307693 ↗
• MalfunctionApr 9, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, THREE GII UNIV PS FEMORAL IMPACTOR LEAVES PLASTIC PARTICLES AFTER USE. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14068223 ↗
• MalfunctionApr 6, 2022Flaked; Flaked

  IT WAS REPORTED THAT A GII UNIV PS FEMORAL IMPACTOR HAS CHIPPED COATING ON HOOK. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14023022 ↗
• MalfunctionFeb 21, 2022Flaked; Flaked

  IT WAS REPORTED THAT, DURING SET UP FOR A TKA SURGERY, THE PLASTIC COVER OF A GII UNIV PS FEMORAL IMPACTOR WAS NOTICED TO BE CHIPPED. NO SURGICAL DELAY WAS REPORTED TO OCCUR, AND THE PROCEDURE WAS CONCLUDED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO PATIENT HARM REPORTED TO OCCUR DUE TO THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13574114 ↗
• MalfunctionFeb 21, 2022Crack; Crack

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE PLASTIC PART OF A GII UNIV PS FEMORAL IMPACTOR CRACKED PRIOR TO IMPLANTATION. NO SURGICAL DELAY WAS REPORTED TO OCCUR, AND THE PROCEDURE WAS CONCLUDED WITH THE SAME DEVICE. NO PATIENT HARM WAS REPORTED TO OCCUR DUE TO THIS INCIDENT. NO PIECES OF THE IMPACTOR ENTERED THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13573905 ↗
• MalfunctionJan 12, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TOTAL KNEE ARTHROPLASTY, A GENESIS II UNIVERSAL FEMORAL IMPACTOR BROKE INSIDE THE PATIENT. NO PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED BEYOND THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13242178 ↗
• MalfunctionNov 22, 2021Break; Break

  IT WAS REPORTED THAT, THE SIDE OF A GII UNIV PS FEMORAL IMPACTOR HAD SNAPPED OFF. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12856059 ↗
• MalfunctionNov 15, 2021Break; Break

  IT WAS REPORTED THAT, AFTER TOTAL KNEE ARTHROPLASTY, A GENESIS II UNIVERSAL FEMORAL IMPACTOR WAS NOTICED TO BE BROKEN. AS THIS HAPPENED AFTER SURGERY WAS COMPLETED, THE PATIENT WAS NOT AFFECTED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12816761 ↗
• MalfunctionOct 6, 2021Break; Break

  IT WAS REPORTED THAT, AFTER TKA SURGERY, SOME OF THE PLASTIC HOUSING OF A GII UNIV PS FEMORAL IMPACTOR HAS BROKEN OFF. SURGERY HAD BEEN COMPLETED, 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 12583876 ↗
• MalfunctionAug 9, 2021Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT THE GREEN PLASTIC PART ON A GII UNIV PS FEMORAL IMPACTOR HAS CRACKED. THIS IS A CONSIGNED INSTRUMENT AND THE DAMAGE IS DUE TO WEAR AND TEAR AFTER SIGNIFICANT USE. THE DAMAGE WAS NOTICED DURING INSPECTION PRIOR TO A CASE AND ANOTHER CONSIGNED TRAY WAS OPENED TO USE FOR THE CASE. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12297522 ↗
• MalfunctionJun 24, 2021Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT AFTER A TKA, THE GII UNIV PS FEMORAL IMPACTOR WAS FOUND TO BE WORN. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. AFTER VISUAL INSPECTION OF THE REPORTED DEVICE IT WAS DETERMINED THAT THE TIP IS CRACKED AND BROKEN, RENDERING IT INOPERABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12058314 ↗
• MalfunctionJun 17, 2021Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE PLASTIC PART OF TWO GENESIS II UNIV PS FEMORAL IMPACTORS BROKE AWAY DUE TO GENERAL WEAR. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12020573 ↗
• MalfunctionJun 17, 2021Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE PLASTIC PART OF TWO GENESIS II UNIV PS FEMORAL IMPACTORS BROKE AWAY DUE TO GENERAL WEAR. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12020543 ↗

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