NA 2294-53-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295113737), received between Aug 30, 2018 and May 16, 2025 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2025Break; Break

  IT WAS REPORTED THE RUBBER SEALS ON SEVERAL TRIALS WERE TORN. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036438 ↗
• MalfunctionSep 13, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT UPON INSPECTION THE FOLLOWING PARTS WERE FOUND. LCS/SIG REV FEM SLVE TRL 31M - BAD RUBBER RING INSIDE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20213187 ↗
• MalfunctionJul 12, 2021Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE PLUS 5 ADAPTER TRIAL HAS BEEN USED BEFORE AND WAS DAMAGED WHEN TRYING TO TAKE IT OUT OF THE 31MM SLEEVE TRIAL. THE METAL HAS BEEN SCRAPED UP AND THE TRIALS DON¿T FIT TOGETHER CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12154782 ↗
• MalfunctionOct 10, 2018Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE TWO TRIALS IS NO LONGER POSSIBLE TO DISCONNECT. NO SURGERY PROLONGATION, NO ADVERSE CONSEQUENCES FOR PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7952001 ↗
• MalfunctionOct 8, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE FEMORAL TRIAL WOULD NOT HOLD THE STEM TRIAL DURING CASE. THE RING ON THE END OF THE TORQUE WRENCH SNAPPED OFF WHEN TIGHTENING FINAL COMPONENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7943870 ↗
• MalfunctionAug 30, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  O-RING HAS DETERIORATED INSIDE TRIAL SLEEVE AND TIBIAL BROACH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7833102 ↗