SIGMA 1960-50-600Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295075172), received between Apr 20, 2018 and Feb 10, 2021 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2011, DATE OF REVISION: (B)(6) 2020, (RIGHT KNEE). TREATMENT: REVISION OF TOTAL KNEE CONSTRUCT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 11311606 ↗
• InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. ALL COMPONENTS REMOVED. DOI: (B)(6) 2011, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 11107793 ↗
• InjuryFeb 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SPACER WAS EXPLANTED AND A NEW ONE IMPLANTED. HAS BEEN IN FOR TWO YEARS AND REINFECTED. DOI: 2 YEARS. DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9681331 ↗
• InjuryJan 29, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS THE LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS AT THE CEMENT TO THE IMPLANT INTERFACE. UNKNOWN BONE CEMENT WAS USED. IT IS ALSO UNKNOWN WHERE OR WHO DID THE PREVIOUS SURGERY AND LOT #S COULD NOT BE FOUND FOR ALL PRODUCTS THAT WERE REMOVED AND AS WELL AS THE PART NUMBER OF THE POLY THAT WAS REMOVED. THE PATELLA WAS LEFT IN PLACE. DOI: UNKNOWN; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9641496 ↗
• InjuryOct 23, 2018Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMUR AT THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACE.

  Patient problems: No Code Available

  MAUDE report 7996087 ↗
• InjuryApr 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS NICKEL ALLERGY AND LOOSENING OF UNKNOWN COMPONENT AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. IT WAS ALSO REPORTED THAT ALL IMPLANTS WERE EXPLANTED AND PUT IN KNEE FOR HYPERSENSITIVE NICKEL ALLERGY. DOI: (B)(6) 2016. DOR: (B)(6) 2018. RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hypersensitivity/Allergic reaction; Not Applicable; Pain

  MAUDE report 7446491 ↗