S-ROM 54-0002Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295173519), received between Sep 13, 2019 and Apr 7, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE SURGERY VIA THA FOR RIGHT OA WITH THE TRIANGLE MILLER SHELL IN QUESTION. DURING THE SURGERY, THE SURGEON ASSEMBLED THE TRIANGLE MILLER SHELL TO A SHAFT AND USED THEM. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE SURGEON TRIED TO DISSEMBLE THE MILLER SHELL FROM THE SHAFT, BUT HE COULDN¿T. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11628968 ↗
• MalfunctionSep 13, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  GUIDES ARE TO WORN AND NOT FUNCTIONAL. PATIENT STATUS / OUTCOME / CONSEQUENCES? NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9030784 ↗