SIGMA 2011-03-015Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295081364), received between Jul 21, 2017 and Jul 9, 2024 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Break” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionJul 9, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE TRIAL IS BENT AND WILL NO LONGER WORK. THE EVENT DID NOT HAPPEN DURING A SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19707490 ↗
• MalfunctionJun 18, 2024Break; Break

  IT WAS REPORTED THAT THE TRIALS WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19564187 ↗
• MalfunctionJun 18, 2024Break; Break

  IT WAS REPORTED THAT THE TRIALS WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19564185 ↗
• MalfunctionJan 3, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BOX TRIAL NO LONGER CONNECTS TO FEMUR. IT WAS UNKNOWN ABOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18434866 ↗
• MalfunctionMar 16, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT SZ 4 AND 5 TC3 BOX TRIALS BENT AT BOTTOM. PIECE REMOVED AND TOSSED. SCREWDRIVER STRIPPED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16551628 ↗
• MalfunctionDec 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSTRUMENT WILL TORQUE BUT NOT LATCH. THE INSTRUMENT WILL NOT SECURE TIGHTLY IN SCREW SLOT. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15940880 ↗
• MalfunctionApr 25, 2022Naturally Worn; Naturally Worn

  THE TRIAL SCREW STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14193202 ↗
• MalfunctionOct 20, 2021Break; Break

  A. ACCOUNT NAME: THIS WAS A LOANER TRAY FROM OUR OFFICE. B. PLEASE PROVIDE THE DATE OF EVENT. THIS COMPLAINT WAS RECEIVED ON (B)(6) 2021. I DON¿T KNOW WHEN THE ACTUAL DAMAGE OCCURRED. I ONLY NOTICED IT WHEN I HAD THE INSTRUMENT SENT IN. C. PLEASE PROVIDE THE LOT NUMBER OF THE SIG HP REV TC3 BOX TRIAL SZ5. OUR OFFICE NOW HAS THE INSTRUMENT TO BE SENT BACK SO THEY I CAN¿T GET THE LOT # PERSONALLY ANYMORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12666315 ↗
• MalfunctionSep 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TC3 BOX TRIAL WOULD NOT TIGHTEN TO THE FEMORAL TRIAL. NO FURTHER INFORMATION IS AVAILABLE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12476897 ↗
• MalfunctionMar 18, 2020Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE FOOT PEGS FELL/ LOCKING SCREW FELL OUT OF BOX TRIAL. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9848495 ↗
• MalfunctionMar 10, 2020Break; Break

  IT WAS REPORTED THAT THE TC3 SIZE 5 BOX TRIAL CAME APART THE FOLLOWING DAY AFTER IT WENT THROUGH CENTRAL STERILE AND CLEANING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9811797 ↗
• MalfunctionJan 10, 2020Material Twisted/Bent; Material Twisted/Bent

  WORN OUT PER CENTRAL STERILE PROCESSING. CSR ASKED FOR REPLACEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9575400 ↗
• MalfunctionNov 6, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE SIZE 5 BOX TRIAL SEEMS BENT AND WILL NOT CONNECT TO THE SIZE 5 FEMUR TRIAL. BOTH PARTS BEING RETURNED. NO TIME ADDED TO CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9287701 ↗
• MalfunctionSep 23, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TC3 SIZE 5 BOX DISTAL FEET WAS BENT AND NOT ADHERE TO THE SIZE 5 TRIAL. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9105922 ↗
• MalfunctionApr 3, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE BOX TRIAL FOR THE FEMUR NO LONGER FITS DUE TO ONE PART BEING BENT. NO SURGICAL DELAY HAPPEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8480164 ↗
• MalfunctionApr 1, 2019Crack; Material Twisted/Bent; Crack; Material Twisted/Bent

  IT WAS REPORTED THAT DURING INSPECTION OF THE INSTRUMENTS IT WAS NOTICED THAT THERE WAS SOME CRACKING AND BENDING GOING ON WITH THE FEET ON THE NOTCH TRIALS IN THE SIGMA REVISION INSTRUMENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8470468 ↗
• MalfunctionFeb 25, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT THE SMALL SCREW THAT ALLOWS THE FIXATION OF THE TC3 BOX ON THE TEST FEMUR WAS MISSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8367561 ↗
• MalfunctionJan 2, 2019Break; Break

  IT WAS REPORTED THAT THE LOCKING MECHANISM FOR POSTERIOR CONDYLES FAILED WHEN SCREW WAS LOOSENED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8207804 ↗
• MalfunctionMay 10, 2018Bent; Crack; Bent; Crack

  IT WAS REPORTED THAT THE SIGMA BOX TRIAL SIZE 4 AND SIZE 5 MECHANISM THAT TIGHTENS THE BOX TO THE FEMUR TRIAL WAS BENT AND CRACKED. THE BOX TRIAL WOULD NOT FULLY SEAT ONTO THE FEMUR TRIAL. NO PIECES WERE BROKE OFF JUST NEED TO BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7502082 ↗
• MalfunctionMar 8, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A REVISION THEY REALIZED THAT THE BOX HAD BEEN STRIPPED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7323201 ↗
• MalfunctionMar 5, 2018Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE BOX TRIAL WILL NOT SCREW INTO THE FEMUR. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7313407 ↗
• MalfunctionNov 28, 2017Disassembly; Disassembly

  IT STATES THAT AFTER SURGERY A FEW WEEKS BACK THE POSTERIOR LOCKING SCREW USED TO LOCK THE BOX TO THE FEMORAL TRIAL SEPARATED FROM THE REST OF THE INSTRUMENTS AS THE FEMORAL TRIAL WAS BEING DISASSEMBLED.

  Patient problems: No Information

  MAUDE report 7063219 ↗
• MalfunctionOct 24, 2017Break; Break

  IT WAS REPORTED THAT THE OFFICE SET SIG HP REV TC3 BOX TRIAL SZ5 BROKE.

  Patient problems: No Information

  MAUDE report 6973852 ↗
• MalfunctionOct 6, 2017Break; Break

  IT WAS REPORTED THAT THE SCREW MECHANISM IN THE BACK OF THE BOX TRIAL CAME APART AND IS NOW MISSING. DON'T THINK IT WAS DEFECTIVE BUT THOUGHT THE SCREW JUST BACKED OUT.

  Patient problems: No Information

  MAUDE report 6922180 ↗
• MalfunctionJul 21, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SCREW IS STUCK.

  Patient problems: No Information

  MAUDE report 6732138 ↗