S-ROM 53-4318Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295171935), received between Apr 3, 2019 and Mar 24, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A THA SURGERY FOR OSTEOARTHRITIS OF THE LEFT HIP. DURING THE SURGERY, THE INTRODUCER SLEEVE BODY AND HANDLE WERE DETACHED EASILY. EVENTUALLY, THE HANDLE SLIPPED OUT AND BECAME UNCLEAN, SO THE INTRODUCER SLEEVE BODY HAD TO BE REMOVED BY STRIKING IT FROM THE OPPOSITE DIRECTION WITH A BONE FRAGMENT HAMMER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21683538 ↗
• MalfunctionOct 28, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SLEEVE INTRODUCER WOULD NOT CONNECT TO 20MM SLEEVE INTRODUCER BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12711879 ↗
• MalfunctionJun 17, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT THA WITH INSTRUMENTS IN QUESTION. WHEN THE SURGEON TRIED TO INSERT THE SLEEVE, THE BUTTON AT THE FITTING AREA BETWEEN THE INTRODUCER BODY AND THE HANDLE WAS LOOSE. WHEN THE SURGEON TRIED TO REMOVE THE INTRODUCER, THE BODY REMAINED. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THERE WAS ABOUT 10 MIN SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 12016770 ↗
• MalfunctionNov 3, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PIECE WOULD NOT SLIDE ONTO THE INSERTER HANDLE. NO ISSUE TO THE PATIENT AND NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10778938 ↗
• MalfunctionApr 3, 2019Difficult to Remove; Mechanical Jam; Scratched Material; Difficult to Remove; Mechanical Jam; Scratched Material

  IT WAS REPORTED THAT THE SLEEVE INTRODUCER STUCK ON HANDLE. SURGERY TIME NOT EXTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8479327 ↗