SIGMA 1024-08-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295001805), received between May 30, 2018 and Jun 27, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Component Missing” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: THE CHRONIC EFFUSION WAS THE ISSUE FOR THE REVISION.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 19629220 ↗
• InjuryNov 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF 15 YEAR OLD SIGMA PARTIAL COMPLETED DUE TO PAIN AND STIFFNESS. THE INLAY LOOKS FINE. SMALL SCRATCHES WERE FOUND ON THE SURFACE. FEMUR AND TIBIA VERY STABLE AND PERFECTLY INTEGRATED.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 15749458 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE PAIN. SURGEON CONVERTED TO TOTAL KNEE. DOI: (B)(6) 2017. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11869795 ↗
• InjuryApr 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. TOTAL KNEE REVISION WAS DONE. DOI: (B)(6) 2015 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11676125 ↗
• InjuryAug 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE EVENT WAS DUE TO NATURAL PROGRESSION AFTER 20 YEARS INSITU. THE PATELLA WAS NATIVE AND NO IMPLANT WAS REMOVED DURING REVISION. THERE WAS ALSO NO ALLEGATION AGAINST THE ALL POLY TIBIA.

  Patient problems: No Code Available; Pain

  MAUDE report 10420717 ↗
• InjuryMar 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DUE TO INCREASED PAIN, THE PATIENT'S UNI KNEE WAS CONVERTED TO A TOTAL. DOI: (B)(6) 2017. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9866603 ↗
• InjuryMay 30, 2018Component Missing; Packaging Problem; Component Missing; Packaging Problem

  IT WAS REPORTED THAT ONCE OPENED THE SEALED BOX, SOME STERILE PACKAGE AND SOME LABELS WERE FOUND IN IT INSTEAD OF THE DEVICE. SINCE THE HOSPITAL DIDN'T HAVE ANOTHER PROTHESIS OF THE SAME SIZE, THE INTERVENTION HAD A DELAY OF MORE THAN 2 HOURS.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7554678 ↗