P.F.C. SIGMA 96-1042Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295234708), received between Mar 20, 2018 and Oct 17, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2023Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT THE SCREW IS ROLLED AND WILL NOT PROPERLY ASSEMBLE TO MATING DEVICE. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17948578 ↗
• MalfunctionSep 27, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE SIGMA PS SIZE 2 STB NOTCH TRIAL IS STRIPPED. IT WILL NOT THREAD INTO THE FEMORAL COMPONENT TRIAL. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15494602 ↗
• MalfunctionNov 5, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE FEM BOX SCREW STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9281010 ↗
• MalfunctionNov 5, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE FEM BOX SCREW STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9281008 ↗
• MalfunctionOct 25, 2019Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT THE SCREW OF THE PFC*SIGMA C S(PS)BOX TRIAL SZ3 WAS STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9239305 ↗
• MalfunctionJul 2, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE BOX TRIAL SCREW WAS STRIPPED DUE TO OUR TIGHTENING DURING OPERATION. TRIAL WAS NEITHER USED OR NEEDED FOR OPERATION. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8752883 ↗
• MalfunctionApr 25, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SCREW ON THE SIGMA SZ 5 BOX TRIAL WAS STUCK WOULD NOT LOOSEN. THERE WAS NO DELAY IN THE SURGERY AS THIS WAS IDENTIFIED BEFORE THE CASE STARTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7457671 ↗
• MalfunctionMar 20, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SCREW STRIPPED. DOES NOT LOCK INTO THE FEMORAL TRIAL WELL. IT WAS NOTICED UPON INSPECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7352634 ↗