SIGMA 9505-01-238Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295225430), received between Dec 3, 2017 and Oct 24, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PIECES WERE NOT FITTING TOGETHER. THE EVENT DID NOT OCCUR IN A PROCEDURE. THERE WAS NO SURGEON INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23378420 ↗
• MalfunctionApr 20, 2022Device-Device Incompatibility; Device-Device Incompatibility

  INSTRUMENTS ARE JAMMED TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14160420 ↗
• MalfunctionFeb 23, 2022Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  THE SPRING CAME LOOSE. IT NO LONGER CONNECTS TO THE CUTTING BLOCK. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13588056 ↗
• MalfunctionJul 12, 2021Off-Label Use; Device-Device Incompatibility; Off-Label Use; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DISTAL CUTTING BLOCK AND THE DISTAL CUTTING BLOCK ADAPTOR WERE NOT CONNECTING TOGETHER PROPERLY. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12151128 ↗
• MalfunctionMay 13, 2021Device-Device Incompatibility; Device-Device Incompatibility

  THE INSTRUMENTS ARE NORMALLY EASILY DISCONNECTED FROM EACH OTHER. THE FEMUR RESECTION GUIDE IS USED TO ADJUST FOR THE DISTAL FEMORAL CUT. ON TWO OF THE INSTRUMENTS, THIS SETTING DOES NOT WORK ANY LONGER. NO SURGICAL DELAY, NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11821860 ↗
• MalfunctionMay 13, 2021Device-Device Incompatibility; Device-Device Incompatibility

  THE INSTRUMENTS ARE NORMALLY EASILY DISCONNECTED FROM EACH OTHER. THE FEMUR RESECTION GUIDE IS USED TO ADJUST FOR THE DISTAL FEMORAL CUT. ON TWO OF THE INSTRUMENTS, THIS SETTING DOES NOT WORK ANY LONGER. NO SURGICAL DELAY, NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11821777 ↗
• MalfunctionDec 10, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE KNOB ON THE DISTAL FEMORAL CUTTING GUIDE GETS STUCK, AND THE SLEEVE WRENCH WON¿T PROPERLY GRASP THE TIBIAL SLEEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10986582 ↗
• MalfunctionJul 27, 2018Loose or Intermittent Connection; Device Slipped; Connection Problem; Device-Device Incompatibility; Loose or Intermittent Connection; Device Slipped; Connection Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT CUTTING BLOCK HAS TOO MUCH PLAY WHERE IT ATTACHES TO JIG. LOT UNAVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7726000 ↗
• MalfunctionMay 30, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED SIGMAL DISTAL FEM CONNECTOR IS LOCKED INSIDE DISTAL FEM RESECTION GUIDE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7554324 ↗
• MalfunctionMay 25, 2018Sticking; Positioning Problem

  IT WAS REPORTED THAT DURING THE REVISION OF THIS PATIENT'S RIGHT TOTAL BIOMET KNEE, THE DISTAL CUTTING GUIDE STUCK AND WOULD NOT ADJUST TO CONTROL DISTAL RESECTION. ALL PIECES WERE PRESENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7545314 ↗
• MalfunctionApr 6, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  TOTAL KNEE REVISION (B)(6) HOSPITAL (B)(6) 2018. DISTAL FEMORAL RESECTION GUIDE AND CONNECTOR: UNABLE TO DIAL THE RESECTION GUIDE ALL THE WAY WHEN CONNECTOR IS INSERTED. SEEMS TO JAM UP. WRENCH: DOES NOT GRIP ON TIBIAL IMPLANT WHEN IN USE. FEMALE PATIENT INITIALS:(B)(6), (B)(6) YEARS OLD, (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7402578 ↗
• MalfunctionDec 3, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SIGMA DISTAL CUTTER ON THE DIAL WAS SEIZING UP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7078163 ↗