SIGMA 1960-30-450Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295074977), received between Dec 13, 2017 and Nov 29, 2021 — classified as 4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED OF THE REMOVAL OF TOTAL JOINT PROSTHESIS INSERTION OF ANTIBIOTIC SPACER DUE TO INFECTION. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2014; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12883430 ↗
• InjurySep 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND BONY LOSS ON TIBIA. NO LOOSENING REPORTED AND NO SURGICAL DELAY. DOI: (B)(6) 2013. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12454631 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORTS: THE PATIENT WAS REVISED TO ADDRESS PAIN AND POSSIBLE INFECTION. DEPUY CEMENT WAS USED. NO DELAY IN SURGERY. DOI: (B)(6) 2015, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 12438011 ↗
• InjuryDec 13, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES LATE ONSET OF INFECTION, REVISED TO ANTIBIOTIC SPACER. IT WAS ALSO STATED THAT LOOSENING OCCURRED AT THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2015 ; DOR: (B)(6) 2017 ; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7114047 ↗