SIGMA 97-0432Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295250449), received between Jul 24, 2018 and Mar 27, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO KNEE WAS STIFF AND POLY WAS EXCHANGED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 21710703 ↗
• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD STIFF KNEE, POLY EXCHANGE. DOE: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 21709823 ↗
• MalfunctionApr 30, 2019Difficult to Insert; Fitting Problem; Defective Device; Difficult to Insert; Fitting Problem; Defective Device

  IT WAS REPORTED THAT THE CVD PLUS INSERT DID NOT LOCK, THEY HAD TO USE ANOTHER INSERT WHICH GOT LOCKED IN FIRST TIME. NO PATIENT CONSEQUENCES. SURGERY COMPLETED BY USING ANOTHER INSERT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8564818 ↗
• MalfunctionJul 24, 2018Fitting Problem; Defective Device; Fitting Problem; Defective Device

  PFC KNEE REPLACEMENT, (B)(6), (B)(6) HEALTH (B)(6) 2018. DURING THE IMPACTING OF THE LINER IT WOULD NOT SEAT INTO THE TRAY, THE SURGEON TRIED SEVERAL TIME TO RESEAT, A NEW LINER WAS OPENED AND THE NEW LINER FITTED FIRST TIME. ON INSPECTION ONE OF THE TAPS ON THE UNDERNEATH OF THE LINER DID NOT LOOK LIKE THE OTHER SIDE. PATIENT INITIAL (B)(6), AGED (B)(6) YEARS, DOB: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7714551 ↗