SIGMA 1960-69-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295075356), received between Dec 21, 2018 and Jul 14, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. SURGEON REMOVED ALL COMPONENTS AND PUT IN SPACERS. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10271845 ↗
• InjuryJul 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAINFUL STIFF KNEE. DOI: (B)(6) 2018; DOR: (B)(6) 2019 LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8757667 ↗
• MalfunctionDec 21, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DER STATES FEMUR IMPLANT WAS SEVERELY SCRATCHED AND NOT USABLE, CAME FROM ORIGINAL PACKAGING DAMAGED. A SECOND FEMUR IMPLANT WAS OPENED. THE DAMAGED IMPLANT IS BEING RETURNED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8190237 ↗