GENESIS II 71440472Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 03596010329875), received between Jul 28, 2019 and Nov 21, 2025 — classified as 1 injury, 36 malfunctions.

The most frequently reported specific device problem is “Break” (18 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, AT THE TIME OF IMPLANTATION OF THE TIBIAL COMPONENT, ONE (1) GII TIB TRY IMPL IMPACTOR WAS DISASSEMBLED, AND IT WAS FOUND THAT THE SCREW THAT HOLDS THE CLAMPING PLATE TO THE IMPACTOR HANDLE WAS FRACTURED, PREVENTING THE IMPLANT FROM BEING REASSEMBLED IN THE POSITIONER. NO PIECE FELL INSIDE THE WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT CURRENT HEALTH STATUS IS STABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617348 ↗
• MalfunctionOct 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT DURING THE IMPLEMENTATION OF THE TIBIAL COMPONENT ONE (1) GII TIB TRY IMPL IMPACTOR CAME APART. ALL PARTS WERE ACCOUNTED FOR. 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 23364106 ↗
• MalfunctionJun 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, UPON IMPLANTING THE TIBIAL IMPLANT, THE SCREW ON THE BACK OF THE GII TIB TRY IMPL IMPACTOR BROKE OFF INTO THE BOLT OF THE IMPACTOR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19487287 ↗
• InjuryApr 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GII TIB TRY IMPL IMPACTOR BROKE OFF DURING TIBIAL IMPLANT IMPACTION. THE PIECE FELL INTO THE BONE AND STILL REMAINS INTO THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, IF THERE WAS ANY DELAY OR IF THE BROKEN PIECE WILL BE REMOVED FROM THE PATIENT. NO FURTHER DETAILS PROVIDED AT THE MOMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19130518 ↗
• MalfunctionNov 27, 2023Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE LOCK NUT OF ONE (1) GII TIB TRY IMPL IMPACTOR BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209390 ↗
• MalfunctionOct 31, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, THE LIP ON THE TOP OF ONE (1) GII TIB TRY IMPL IMPACTOR BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING 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 18039918 ↗
• MalfunctionDec 27, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, THE HANDLE OF A GII TIB TRY IMPL IMPACTOR BROKE. SURGERY WAS RESUMED, 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 16056329 ↗
• MalfunctionOct 18, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ONE GII TIB TRY IMPL IMPACTOR WAS CHIPPED AT THE PLASTIC SECTION. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15629422 ↗
• MalfunctionMay 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, THE TIP OF A GENESIS II TIBIAL TRAY IMPLANT IMPACTOR BROKE OFF BEFORE IT WAS USED IN THE PATIENT. SURGERY WAS PERFORMED WITH A CHANGE IN SURGICAL TECHNIQUE, IN WHICH THE SURGEON CARRIED OUT THE PROCEDURE MANUALLY. IT IS UNKNOWN IF THERE WAS A DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14450770 ↗
• MalfunctionMar 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING SET UP, THE GII TIB TRY IMPL IMPACTOR FELL APART WHILE ASSEMBLING IT. PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13870259 ↗
• MalfunctionFeb 23, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GII TIB TRY IMPL IMPACTOR HAVE BECOME DAMAGED DUE TO USE AND WOULD NOT HOLD THE FINAL TIBIAL BASEPLATE ANYMORE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. THE PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13588780 ↗
• MalfunctionFeb 23, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GII TIB TRY IMPL IMPACTOR HAVE BECOME DAMAGED DUE TO USE AND WOULD NOT HOLD FINAL TIBIAL BASE PLATE ANYMORE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13588774 ↗
• MalfunctionDec 21, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT, THE CAPTURE WAS MISSING FROM THE GII TIB TRY IMPL IMPACTOR. IT IS UNKNOWN WHEN THE EVENT HAPPENED OR IF THERE WAS ANY DELAY NOR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13052365 ↗
• MalfunctionNov 17, 2021Break; Break

  IT WAS REPORTED THAT A GENESIS II TIBIAL TRAY IMPLANT IMPACTOR IS BROKEN. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12827430 ↗
• MalfunctionSep 30, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A GENESIS II TIB TRY IMPL IMPACTOR HEAD IS LOOSE. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12558490 ↗
• MalfunctionSep 27, 2021Failure to Align; Device Dislodged or Dislocated; Failure to Align; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, A GENESIS II TIBIAL TRAY IMPLANT IMPACTOR FAILED TO GRIP ONTO THE BASEPLATE. IN ADDITION, ON IMPACTION THE SCREW CAME LOOSE. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12532311 ↗
• MalfunctionSep 24, 2021Break; Break

  IT WAS REPORTED THAT THE CAPTURE OF A GENESIS II TIBIAL TRAY IMPLANT IMPACTOR BROKE OFF. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12530596 ↗
• MalfunctionSep 15, 2021Degraded; Degraded

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PLASTIC COMPONENT OF ONE GII TIB TRY IMPL IMPACTOR WAS DEGRADED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO HEALTH CONSEQUENCES ON THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12478877 ↗
• MalfunctionJul 9, 2021Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, A GII TIB TRY IMPL IMPACTOR BROKE, OUTSIDE OF THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12144585 ↗
• MalfunctionJul 5, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT, DURING STEP UP, BEFORE A TKA SURGERY, IN ONE (1) GII TIB TRY IMPL IMPACTOR THE MAIN SCREW CAME LOOSE. THIS HAPPENED BEFORE USE IN PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. NO HEALTH CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12119207 ↗
• MalfunctionJun 23, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A SCREW FROM A GII TIB TRY IMPL IMPACTOR FELL AND WAS LOST IN THE DECONTAMINATION AREA. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12053685 ↗
• MalfunctionMay 13, 2021Break; Connection Problem; Break; Connection Problem

  IT WAS REPORTED THAT DURING A TKA, THE GENESIS II TIB TRY IMPL IMPACTOR BROKE DURING SURGERY (OUTSIDE THE PATIENT) AND WOULD NOT LOCK INTO TIBIA BASEPLATE. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11820860 ↗
• MalfunctionApr 2, 2021Break; Break

  IT WAS REPORTED THAT DURING A TKA, THE LOCKING MECHANISM OF THE GII TIB TRY IMPL IMPACTOR BROKE. INSTRUMENTS OUTSIDE PATIENT. PROCEDURE FINISHED WITH S&N BACKUP DEVICE. NO SURGICAL DELAY OR INJURY TO PATIENT REPORTED DUE THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610707 ↗
• MalfunctionMar 11, 2021Break; Connection Problem; Break; Connection Problem

  IT WAS REPORTED THAT, DURING INSPECTION IT WAS NOTICED THAT THE GENESIS II TIB TRY IMPL IMPACTOR WAS CHIPPED AND COULD NOT HOLD THE TIBIAL BASEPLATE PROPERLY. ALL PIECES GOT RECOVERED. INCIDENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11458337 ↗
• MalfunctionMar 1, 2021Break; Break

  IT WAS REPORTED THAT, DURING A GENESIS II FEMORAL IMPACTOR WAS CHIPPED AND FLAKING. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11391221 ↗