S-ROM 53-4316Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295171928), received between Aug 13, 2018 and Oct 23, 2020 — 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.

• MalfunctionOct 23, 2020Device-Device Incompatibility; Device-Device Incompatibility

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020 VIA THA. DURING THE SURGERY, THE SURGEON INSERTED A SLEEVE WITH THE INTRODUCER SLEEVE BODY CONNECTED THE HANDLE SLEEVE DRIVER. THEN, THE SURGEON TRIED TO REMOVE THE DEVICES WITH A HAMMER, THE CONNECTION POINT OF THE INTRODUCER SLEEVE BODY AND THE HANDLE SLEEVE DRIVER CAME OFF EASILY. THE SURGEON COULD REMOVE THE DEVICES WITH TRYING A FEW TIMES. AFTER THAT, THE NURSE CHECKED THE DEVICES, HE/SHE COULD NOT DISCONNECT THE DEVICES BY HAND. HOWEVER, HE/SHE TRIED TO GET THEM OFF WITH A HAMMER, THE DEVICES CAME OFF EASILY. THE SURGERY WAS COMPLETED WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 10726648 ↗
• MalfunctionOct 10, 2019Connection Problem; Device-Device Incompatibility; Material Deformation; Naturally Worn; Connection Problem; Device-Device Incompatibility; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT THE SIZE 16 SLEEVE INTRODUCER AND HANDLE NO LONGER STAY ATTACHED. DOCTOR INDICATES BOTH PARTS WERE WORN AND NEEDED REPLACING. PLEASE SEND REPLACEMENT PARTS TO KNOXVILLE OFFICE. THERE WAS A 30 SECONDS SURGICAL DELAY.

  Patient problems: Not Applicable

  MAUDE report 9175669 ↗
• MalfunctionAug 13, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2018 VIA THA. AFTER THE TRIAL SLEEVE WAS INSERTED TO THE PATIENT¿S FEMUR, IT WAS REPORTED THAT THE SURGEON FELT DIFFICULTY TO REMOVE THE TRIAL SLEEVE BECAUSE THE CONNECTION PART OF THE SLEEVE INTRODUCER AND INTRODUCER HANDLE WERE DETACHED WHEN THE SURGEON HIT THE CONNECTION PART TO RELEASE WHILE THE TRIAL SLEEVE WAS REMOVED. THE SURGEON ATTEMPTED TO REMOVE THE TRIAL SLEEVE SEVERAL TIMES, AND FINALLY IT WAS REMOVED BY USING ELEVATORS. THE SAME CONDITION WAS OCCURRED (DIFFICULTY TO RELEASE) WHEN THE SLEEVE WAS IMPLANTED TO PATIENT¿S FEMUR. THERE WAS LESS THAN 30MIN. SURGICAL DELAY AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: Not Applicable

  MAUDE report 7777444 ↗