SIGMA 1960-50-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295075103), received between Mar 28, 2024 and Mar 12, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT UNDERWENT A PRIMARY SURGERY ON (B)(6) 2009. ON (B)(6) 2019, A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING OF THE FEMORAL COMPONENT. AFTER THE SURGERY, A SECOND REVISION WAS PERFORMED ON (B)(6) 2025 DUE TO LOOSENING OF THE TIBIAL TRAY. THIS REPORT CAPTURES THE LOOSENING OF THE FEMORAL COMPONENT WHICH OCCURRED AFTER THE PRIMARY SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 21585169 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION COMPLAINT RECEIVED AD 12 MAR 2024 WAS REVIEWED BY CLINICIAN. ON (B)(6) 2014, THE PATIENT HAD A BILATERAL CEMENTED TOTAL KNEE ARTHROPLASTY TO ADDRESS, BILATERAL KNEE PAIN AND BILATERAL KNEE OSTEOARTHRITIS END-STAGE. ALL COMPONENTS IMPLANTED WERE DEPUY PRODUCTS, INCLUDING THE CEMENT AND PATELLA. ON (B)(6) 2020, THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY, TO ADDRESS MECHANICAL LOOSENING OF INTERNAL RIGHT KNEE PROSTHETIC JOINT. THE SURGEON REPORTED FINDING TIBIAL TRAY LOOSENING. THE FEMORAL COMPONENT WAS WELL FIXED, BUT THERE WAS SIGNIFICANT OSTEOLYSIS BEHIND THE FEMORAL IMPLANT WITH LARGE CAVITARY DEFECT. SIGNIFICANT SYNOVITIS WAS ALSO NOTED. COMPETITOR PRODUCTS WERE IMPLANTED DURING THIS PROCEDURE. DOI: (B)(6) 2014 DOR: (B)(6) 2020 RIGHT KNEE.

  Patient problems: Osteolysis; Synovitis; Unspecified Musculoskeletal problem

  MAUDE report 18993050 ↗