SIGMA 2011-03-012Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295081333), received between Aug 23, 2017 and Jan 15, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2025Break; Break

  IT WAS REPORTED THAT THE NON-REMOVABLE SET SCREW ON THE 2.5 TC3 BOX TRIAL WAS BROKEN AND NEEDED TO BE REPLACED. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21161571 ↗
• MalfunctionAug 3, 2022Break; Break

  IT WAS REPORTED THAT THE TRIAL IS BROKEN. NO IMPACT ON SURGERY OR PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15156743 ↗
• MalfunctionApr 13, 2022Break; Break

  IT WAS REPORTED THAT DURING CLEANUP REP NOTED THAT THE PIECE WAS BREAKING AT THE THREADED SCREW JUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14102120 ↗
• MalfunctionJan 14, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BOX TRIAL HAVING DIFFICULTY CONNECTING TO FEMORAL TRIAL. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13257646 ↗
• MalfunctionSep 21, 2020Break; Break

  TC3 BOX TRIAL TABS BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10563765 ↗
• MalfunctionJul 22, 2020Break; Break

  IT WAS REPORTED THAT THE SIGMA TIBIA IMPACTOR BROKE IN HALF WHILE IMPACTING THE IMPLANT. ADDITIONALLY, THE UNIVERSAL INSERT HANDLE BROKE WHILE IMPACTING FEMUR. LASTLY, IT WAS ALSO REPORTED THAT THE SIZE 2.5 FEMORAL TRIAL BROKE WHILE REMOVING FEMUR POST TRIALING. NO SURGICAL DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10306292 ↗
• MalfunctionMay 15, 2020Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT THE BOX TRIAL BROKE WHILE TRAILING THE FEMORAL COMPONENT.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 10061739 ↗
• MalfunctionFeb 25, 2020Break; Break

  IT WAS REPORTED THAT THE SCREW IN THE FRONT OF THE SIZE 2.5 AND SIZE 3 SIGMA TC3 FEMORAL TRIAL BOXES CAME OUT AND NEEDS TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9752124 ↗
• MalfunctionSep 13, 2019Break; Break

  IT WAS REPORTED THAT THE SECOND STAGE OF A TWO STAGE REVISION WAS DUE TO INFECTION. CEMENT SPACES WERE REMOVED. THE SIGMA HP REVISION SYSTEM WAS USED FOR REIMPLANTATION. THE SURGERY PROCEEDED AS PLANNED AND WAS ACCOMPLISHED WITHOUT ANY ISSUES OR DELAYS. UPON DISASSEMBLING THE 2.5 BOX TRIAL IN CENTRAL STERILE AFTER THE SURGERY, THE BOX TRIAL "FELL APART". ALL OF THE PIECES WERE RECOVERED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9027365 ↗
• MalfunctionJun 3, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT TC3 TRIAL BOX COULD NOT ATTACH TO THE TRIAL FEMUR. SOMETHING IS BENT ON THE 2.5 TC3 TRIAL BOX.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8664066 ↗
• MalfunctionMay 30, 2018Break; Break

  IT WAS REPORTED UPON DISASSEMBLY THE FEET OF THE TRIAL BROKE. ALL PIECES ARE ACCOUNTED FOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7554723 ↗
• MalfunctionApr 19, 2018Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT TC3 BOX TRIAL AND SCREW DRIVER SHAFT WAS NOT WORKING PROPERLY. NEEDS TO BE REPLACED, PRODUCTS WILL BE RETURNED. ITEMS ARE BROKEN AND STRIPPED. THESE ARE AN OFFICIAL SET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7442896 ↗
• MalfunctionApr 11, 2018Fracture; Fracture

  THE INSTRUMENTS WAS REPORTED FOR UNKNOWN REASON. EXAMINATION OF THE RETURNED DEVICE FINDS THE PIN JACK FEATURES ARE DISASSOCIATED FROM THE INSTRUMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7422024 ↗
• MalfunctionDec 2, 2017Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE BOLT WAS STUCK INSIDE OF THE BOX AND STRIPPED OUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7077933 ↗
• MalfunctionAug 23, 2017Break; Break

  IT WAS REPORTED THAT TC3 SIZE 2.5 SIGMA REVISION BOX TRIAL LOCKING MECHANISM IS NOT WORKING PROPERLY TO CHANGE FEMUR POSITION AND SIDE, SURGEON ASKED TO HAVE IT REPLACED.

  Patient problems: No Information

  MAUDE report 6815330 ↗