SIGMA 97-2350Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295251095), received between May 9, 2018 and Jun 8, 2022 — classified as 3 malfunctions.

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

• MalfunctionJun 8, 2022Break; Break

  DURING THE IMPLANT TEST, LOOSE PARTICLES OF THE TEST POLYETHYLENE WERE DETECTED. ALL PARTICLES WERE REMOVED. NO SURGICAL DELAY. NO CHANGE IN SURGICAL METHOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14633947 ↗
• MalfunctionNov 5, 2020Break; Break

  IT WAS REPORTED THAT THE TRIAL POLY LEFT TINY PIECES BEHIND IN PATIENT. ANOTHER TRIAL WAS USED FOR CEMENTING AND THE CASE PROCEEDED AS PLANNED. A DELAY OF 1 MINUTE IN SURGERY.

  Patient problems: No Code Available

  MAUDE report 10792301 ↗
• MalfunctionMay 9, 2018Break; Break

  IT WAS REPORTED THAT WHILE TRAILING WITH THE 3 X 8MM CVD+ FB INSERT TRIAL, THE BOTTOM OF THE TRIAL CRACKED AND BROKE OFF. ALL PIECES WERE RETRIEVED FROM THE PATIENT AND SURGERY TIME WAS NOT EXTENDED DUE TO BROKEN INSTRUMENT. NO LOT NUMBER IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7497939 ↗