SIGMA 97-0442Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295250500), received between Jul 23, 2019 and Dec 4, 2025 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Expiration Date Error” (1 report).

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.

• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS SHOWING SIGNS OF INFECTION AFTER A FALL. SURGEON DECIDED TO SWAP POLY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 23716916 ↗
• InjuryJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A POLY SWAP AND THE 20-YEAR OLD SIGMA KNEE WAS REVISED. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17423525 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTED KNEE. ORIGINAL IMPLANT DATE UNKNOWN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16627222 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. WASH OUT WAS PERFORMED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16372891 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S KNEE SHOWED SIGNS OF INFECTION. THE DOCTOR TOOK CULTURES TO SEE IF THEY COULD IDENTITY THE BUG. THE POLY WAS TAKEN OUT AND THE KNEE WAS WASHED. THE SAME SIZE NEW POLY WAS IMPLANTED. THERE WAS NO LOOSENING. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2014, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14142823 ↗
• InjuryApr 21, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THERE WAS REVISION TO CHANGE 20 YEAR OLD PFC SIGMA KNEE INSERT DUE TO WEAR.

  Patient problems: Insufficient Information

  MAUDE report 11702244 ↗
• MalfunctionDec 3, 2019Expiration Date Error; Packaging Problem; Expiration Date Error; Packaging Problem

  IT HAS COME TO NOTICE TODAY ABOUT SURGERY DONE ON MONDAY (B)(6) 2019. EXPIRED ARTICULAR SURFACE IMPLANT IN THE KNEE CONSTRUCT SIZE (2.5* 12.5) HAS BEEN IMPLANTED IN THE PATIENT KNEE. THE IMPLANTS FOR THE SURGERY SUPPLIED BY UNIVERSAL TRADERS, PUNE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9401905 ↗
• InjuryJul 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION TOTAL KNEE FOR STIFFNESS AND LACK OF ROM. KNEE FIXED FLEXION DEFORMITY OF 25 DEGREES. COMPONENTS WELL FIXED AND WELL ALIGNED. PATELLA SKYLINE VIEW WELL POSITIONED. NO OBVIOUS ISSUES TO CAUSE STIFFNESS AS SUCH.

  Patient problems: Joint Disorder; Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8815812 ↗