S-ROM 53-0300Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295171522), received between Jun 19, 2018 and Jul 17, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2023Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS WERE DAMAGED DURING SURGERY DUE TO VERY HARD BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17333669 ↗
• MalfunctionJan 20, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE WHITE ADAPTER SHAFT IS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16214575 ↗
• MalfunctionFeb 9, 2021Break; Break

  BROKEN SROM INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11302066 ↗
• MalfunctionFeb 9, 2021Break; Break

  BROKEN SROM INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11302054 ↗
• MalfunctionDec 17, 2020Unintended Movement; Unintended Movement

  THE PRIMARY SURGERY WAS PERFORMED ON AN UNKNOWN DATE VIA THA. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020. THE REASON OF THE REVISION SURGERY IS THE CUP SINKING TO THE ACETABULAR. THE FIXATION OF THE STEM WAS GOOD, BUT IT WAS REMOVED BECAUSE IT INTERRUPTED TO REMOVE THE CUP. DURING THE SURGERY, WHEN THE SURGEON SET A CONE REAMER TO THE EXTENSION REAMER HUDSON, ATTACHED THEM TO A POWER TOOL AND CHECKED THE ACTION, THE ROTATION WAS ECCENTRIC. THE SURGEON USED THE DEVICES TO DRILL THE FEMORAL MEDULLARY CAVITY, THE SURGEON HAD A RISK TO BREAK THE FEMUR DUE TO THE DEVICE¿S ECCENTRIC ROTATION. HE PROCEEDED WITH THE PROCEDURE CAREFULLY AND AS A RESULT THE DURATION OF THE SURGERY WAS EXTENDED ABOUT LESS THAN 30 MINUTES. THE FEARED EVENT DID NOT HAPPEN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 11026941 ↗
• MalfunctionJul 6, 2020Break; Break

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020 VIA THA. DURING THE SURGERY, AFTER CONE REAMING, THE EXTENSION REAMER (P/N: 530300) BROKE WHEN THE SURGEON DETACHED THE REAMER FROM A POWER TOOL. THE BREAKAGE OCCURRED OUT OF SURGICAL FIELD, AND THE SURGEON CONFIRMED THAT THERE WAS NO PIECE IN THE BODY. THE SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10235979 ↗
• MalfunctionJun 19, 2018Difficult to Remove; Device Contamination with Chemical or Other Material; Difficult to Remove; Device Contamination with Chemical or Other Material

  AFTER RECEIPT OF A LOANER KIT THE CSSD IS COMPLAINING TWO INSTRUMENTS NOT TO BE POSSIBLE TO DISASSEMBLE FOR RE-PROCESSING. RE-PROCESSING OF INSTRUMENTS IS UNCLEAR/DIFFICULT. NO PATIENT INVOLVEMENT, NO SURGERY DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7613559 ↗