SIGMA 2011-03-013Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10603295081340), received between Aug 10, 2017 and Jul 7, 2022 — classified as 1 injury, 33 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE TC3 BOX TRIAL SCREW WAS STRIPPED. NO PIECES LEFT. NO SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14945742 ↗
• MalfunctionMar 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INSTRUMENT WAS REPORTED FOR AN UNKNOWN REASON. THE INSTRUMENT INVOLVE WAS SIGMA REVISION TC3 SIZE 3 BOX TRIAL AND NEEDS TO BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13720488 ↗
• MalfunctionNov 30, 2021Break; Break

  IT WAS REPORTED THAT THE COMPONENT HAS FRACTURED THROUGH THE LOCKING SYSTEM. NO INCIDENT RELATING TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12892684 ↗
• MalfunctionNov 29, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE BOX TRIAL SCREW WAS STRIPPED AND WOULD NOT LOCKED IN. IT WAS DISCARDED BY THE OPERATING ROOM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12885541 ↗
• MalfunctionApr 13, 2021Break; Break

  IT WAS REPORTED THAT THE BOX TRIAL'S ATTACHMENT BROKE AND THE TORQUE WRENCH STRIPPED DURING NORMAL USE. NO DELAY TO SURGERY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11657171 ↗
• MalfunctionFeb 22, 2021Break; Break

  IT WAS REPORTED THAT THE SIGMA SIZE 3 TC3 BOX TRIAL BROKE DURING CASE. EVENT DID NOT CAUSE DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11359185 ↗
• MalfunctionOct 23, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE WINGS ON THE BOX TRIAL ARE NOT ENGAGING PROPERLY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10726836 ↗
• MalfunctionSep 18, 2020Break; Break

  TC3 BOX TRIAL TABS BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10556294 ↗
• MalfunctionSep 18, 2020Break; Break

  IT WAS REPORTED THAT THE SCREW ON THE INSTRUMENT BROKE INTO TWO PIECES. ALL PIECES WERE RECOVERED. THIS DID NOT DELAY THE SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10554775 ↗
• MalfunctionMar 27, 2020Crack; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Crack; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE SIZE 3 TC3 BOX TRIAL WILL NOT SCREW INTO A SIZE 3 FEMORAL TRIAL. BOX TRIAL SEEMS TO BE DEFECTIVE AND IS BEING RETURNED WITH ALL PIECES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9889245 ↗
• MalfunctionMar 25, 2020Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE PRODUCT RECEIVED WITH (B)(4) WITH NO ALLEGATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9878607 ↗
• 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 9752126 ↗
• MalfunctionJan 30, 2020Break; Break

  IT WAS REPORTED THAT DURING TIGHTENING OF THE BOX TRIAL TO THE FEMORAL TRIAL THE BOX BROKE INTO SEVERAL PIECES. ALL PIECES WERE RETRIEVED AND ARE BEING SENT BACK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9648625 ↗
• MalfunctionJan 21, 2020Naturally Worn; Naturally Worn

  STERILE PROCESSING DISCARDED A TC3 HP BOX TRIAL SECONDARY TO THE METAL STUBS THAT ROLL INTO THE SOLID SIGMA FEMORAL TRIALS BEING "WORN OUT".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9613400 ↗
• MalfunctionJan 2, 2020Break; Break

  IT WAS REPORTED THAT WHILE TRYING TO REMOVE THE FEMORAL TRIAL FROM THE FEMUR, THE SIGMA HP REVISION BOX TRIAL WAS BROKEN. THE BAR THAT LOCKS THE BOX TRIAL ONTO THE FEMUR WAS BROKEN AT THE THREADS. ALL PIECES WERE RECOVERED. THE SURGERY WAS NOT DELAYED OR HINDERED IN ANY WAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9539734 ↗
• MalfunctionNov 21, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE FEMUR IMPACTOR WAS BROKEN, SIGMA BOX TRIAL WAS BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9354154 ↗
• MalfunctionOct 25, 2019Component Missing; Component Missing

  MISSING "WINGS".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9240480 ↗
• MalfunctionOct 7, 2019Break; Material Twisted/Bent; Break; Material Twisted/Bent

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. THE TIBIAL TRAY IS WELL FIXED, BUT THE FEMORAL COMPONENT IS LOOSE. THE SURGEON REVISED THE FEMORAL COMPONENT AND RETAINED THE WELL-FIXED TIBIAL TRAY. DURING THE PROCEDURE, THE HUDSON ADAPTOR, FEMORAL ADAPTOR ROD, AND THE #3 TC3 BOX TRIAL BROKE OR WERE STRIPPED. ALL THE PIECES WERE PRESENT. A SURGICAL DELAY OF 1 MINUTE WAS NOTED. DOI: (B)(6) 2018. DOR: (B)(6) 2019. LEFT KNEE.

  Patient problems: Not Applicable

  MAUDE report 9162982 ↗
• 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 8470474 ↗
• MalfunctionNov 16, 2018Loose or Intermittent Connection; Device-Device Incompatibility; Loose or Intermittent Connection; Device-Device Incompatibility

  THE BOX TRIAL WOULD NOT CONNECT PROPERLY INTO THE BACK OF THE FEMORAL COMPONENT - WOULD NOT SEAT PROPERLY INTO THE DIVOTS IN THE POSTERIOR FEMUR. THE GRUB SCREW WAS ALSO COMING OUT OF THE BACK OF THE BOX TRIAL COMPLETELY BUT IT SHOULDN'T BE ABLE TO COME LOOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8081208 ↗
• MalfunctionSep 12, 2018Break; Break

  IT WAS REPORTED THAT THE TC3 FEMUR BOX FEET ARE BROKEN. NOTICED WHILE EXAMINING INSTRUMENTS BEFORE PROCESSING FOR CASE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7869261 ↗
• MalfunctionJun 8, 2018Break; Break

  IT WAS REPORTED THAT THE PEGGS BROKE OFF THAT SECURE THE BOX INTO THE FEMUR WHILE BEING DISASSEMBLED. ALL PIECES RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7582157 ↗
• MalfunctionMay 22, 2018Break; Break

  IT WAS REPORTED THAT THE SCREW OR LOCKING MECHANISM BROKE DURING INSTRUMENT DISASSEMBLY WHILE REASSEMBLING REVISION KNEE INSTRUMENT SET. NOT INVOLVED IN SURGICAL CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7532812 ↗
• MalfunctionMay 15, 2018Break; Break

  IT WAS REPORTED THAT WHEN THE FEMORAL TRIAL ASSEMBLY WERE TAKEN APART AFTER THE CASE WAS DONE, IT WAS OBSERVED THAT THE TC3 REVISION BOX TRIAL SET SCREW HAD BROKEN. ALL PARTS WERE ACCOUNTED FOR. NO SURGICAL DELAY NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7513737 ↗
• MalfunctionFeb 14, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT BOX TRIAL WILL NOT ENGAGE WITH FEMUR TRIAL. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7269960 ↗