SIGMA 86-6501Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295217213), received between Feb 21, 2019 and Sep 28, 2021 — classified as 3 malfunctions.

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

• MalfunctionSep 28, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A REVISION KNEE, A 13X30 MBT CEMENTED STEM TRIAL CAUSE ISSUES IN A CASE BECAUSE IT LACKED THE THREADS NEEDED TO INTERFACE WITH THE EXTRACTION INSTRUMENT. NO PATIENT CONSEQUENCES OR SURGICAL DELAYS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12541489 ↗
• MalfunctionSep 4, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS EXTREMELY SMALL AND HAD TIGHT CANALS AND UPON REMOVING TRIAL THE 13 X 30 CEMENTED TRIAL STEM WAS BROKEN AND BENT THE RETRIAL HANDLE.

  Patient problems: Not Applicable

  MAUDE report 8962013 ↗
• MalfunctionFeb 21, 2019Entrapment of Device; Entrapment of Device

  DURING A TKA YESTERDAY, THE 13X30 CEMENTED STEM TRIAL WAS LEFT IN THE PATIENT. IT WAS USED WITH A SIGMA KNEE. THE IMPLANT WAS CEMENTED IN PLACE AND THE WOUND CLOSED. THE RETAINED STEM WAS NOTED ON THE X-RAY AFTER THE PATIENT WAS OUT OF THE OR. THE DOCTOR HAS ELECTED TO LEAVE THE STEM TRIAL IN THE MEDULLARY TIBIAL CANAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8358570 ↗