NA 2294-53-130Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295113751), received between May 13, 2020 and Apr 18, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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.

• MalfunctionApr 18, 2024Naturally Worn; Naturally Worn

  THE O-RING IN THE SIGMA FEMORAL SLEEVE TRIAL IS DAMAGED AND NEEDS REPLACING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19133402 ↗
• MalfunctionAug 26, 2022Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ORANGE COLORED O RING IN THE SIGMA REV 40MM FEMORAL SLEEVE TRIAL HAS FALLEN OUT. AS A RESULT, THE UNIVERSAL FLUTED STEM TRIALS ARE NOT SECURE WHEN ATTACHED TO THE SLEEVE TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15303462 ↗
• MalfunctionMay 13, 2020Device-Device Incompatibility; Device-Device Incompatibility

  SURGEON WAS UNABLE TO CONNECT THE SAMPLE SLEEVE TO THE SAMPLE FEMUR WITH THE USE OF SCREW: 217861100. ALLEGATION AGAINST THE SCREW 217861100. PATIENT: (B)(6) OLD. SURGERY DELAY: 20MIN. NO ADVERSE PATIENT HARM. SURGERY PERFORMED: MBT REVISION AND LCS VVC BY LYING SPACER. SURGERY SUCCESSFULLY COMPLETED.

  Patient problems: Not Applicable

  MAUDE report 10052548 ↗