SIGMA 9505-01-263Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295225669), received between Dec 22, 2017 and Sep 19, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2024Incorrect Measurement; Incorrect Measurement

  FAULTY FEMORAL SIZING GUIDE NO FURTHER INFORMATION IS AVAILABLE AT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20255264 ↗
• MalfunctionJan 31, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE SIZE BROKE DUE TO WEAR AND TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18615462 ↗
• MalfunctionJun 23, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE STYLUS ON THE HP SIZER GUIDE IS COLD WELDED AND WILL NOT MOVE. NO PIECES BROKE OFF OF THE INSTRUMENT. THERE WAS NO DELAY SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14790647 ↗
• MalfunctionApr 28, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ONE OF THE POSTERIOR FEET OF THE FIXED REFERENCE SIZER WAS FOUND BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11738652 ↗
• MalfunctionOct 27, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  DURING CASE THE FEMORAL SIZER AND THE FEMORAL POSTERIOR REFERENCING FEMORAL ROTATION GUIDES WERE NOT GOING TOGETHER EASILY. THEN ONCE WE GOT IT ON IT WAS EXTREMELY DIFFICULT TO TAKE OFF. HAD TO USE A HOHMAN TO REMOVE THE FEMORAL ROTATION GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 10741443 ↗
• MalfunctionApr 29, 2020Material Discolored; Material Twisted/Bent; Material Discolored; Material Twisted/Bent

  INSTRUMENTS SHOW SIGNS OF WEAR AND DISCOLOURATIONS. NOTICED DURING CLEANING PROCESS. NO SURGICAL AFFECT. NO PATIENT AFFECT. INSTRUMENTS ARE FURTHER IN USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10012585 ↗
• MalfunctionMay 22, 2019Material Twisted/Bent; Material Twisted/Bent

  STYLUS FOR FIXED REF FEMORAL SIZER WILL NOT SCREW DOWN. PATIENT STATUS/OUTCOME/CONSEQUENCES: NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8631743 ↗
• MalfunctionFeb 22, 2019Mechanical Jam; Mechanical Jam

  THE INSTRUMENTS MOVABLE PART / SENSING ELEMENT BECAME STUCK AND IS NO LONGER POSSIBLE TO MOVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8361520 ↗
• MalfunctionFeb 11, 2019Failure to Disconnect; Failure to Disconnect

  THE INSTRUMENT IS NO LONGER POSSIBLE TO DISASSEMBLE AS THE SCREW WAS TIGHTENED TOO TIGHTLY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8327998 ↗
• MalfunctionJan 10, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN INSTRUMENT DEMO WITH THE SURGEON, THE FEMORAL SIZER WAS NOTED TO BE BENT AND DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8235242 ↗
• MalfunctionJan 9, 2018Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE INSTRUMENT WAS DEFECTIVE ON THE KIT WHEN IT ARRIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7176343 ↗
• MalfunctionJan 9, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE INSTRUMENT´S WINDING BUTTON IS JAMMED AND IS NOT POSSIBLE TO MOVE ANY LONGER. NO ADVERSE EFFECT FOR PATIENT, NO SURGERY PROLONGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7174970 ↗
• MalfunctionDec 22, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE KNOB WILL NOT LOOSEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7142543 ↗