SIGMA 1960-73-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295075479), received between Sep 17, 2019 and Jan 15, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LIGAMENTOUS INSTABILITY. THERE WAS TIBIAL LOOSENING AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI: (B)(6) 2020, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24079854 ↗
• InjuryDec 2, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF FEMUR AND TIBIA AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20820038 ↗
• InjuryJan 25, 2023Loss of or Failure to Bond; No Apparent Adverse Event; Loss of or Failure to Bond; No Apparent Adverse Event

  THE CEMENT HAS DISINTEGRATED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16239712 ↗
• InjuryFeb 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS LATE LIGAMENTOUS INSTABILITY. NO DELAY IN SURGERY. DOI: (B)(6) 2018; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11350979 ↗
• InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT KNEE REVISION - ORIGINAL SURGERY (B)(6) 2016. REMOVED FEMUR, TRAY & INSERT DUE TO INSTABILITY AND PAIN. LOOSENING IMPLANT TO CEMENT.

  Patient problems: Joint Laxity; Pain

  MAUDE report 10963107 ↗
• InjuryJul 28, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS AT CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. REIMPLANTED WITH A TC3 REVISION KNEE. DOI: (B)(6) 2014; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10335475 ↗
• InjurySep 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT RETURNED TO SURGERY FOR REVISION TO A KNEE SPACER FOR AN INFECTION. ALL THE IMPLANTS WERE REMOVED. DOI: (B)(6) 2018. DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9078417 ↗