S-ROM 53-4153Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295171751), received between Nov 28, 2017 and Apr 24, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (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 16, 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.

• MalfunctionApr 24, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THESE INSTRUMENTS HAVE REACHED END OF LIFE. THE SURGEONS HAD CONTINUALLY COMPLAINED ABOUT WEAR AND TEAR OF INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981745 ↗
• MalfunctionApr 24, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THESE PRODUCT HAVE REACHED END OF LIFE DUE TO WEAR AND TEAR. THE SURGEONS ARE COMPLAINING ABOUT INSTRUMENT BEING DULL, ILLEGIBLE, AND GENERALLY WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981334 ↗
• MalfunctionJul 20, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE SROM 18X13 PILOT SHAFT STEM TRIAL THREADS ARE WORN. NO ADDITIONAL SURGERY TIME REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15064503 ↗
• MalfunctionJul 20, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE SROM 18X13 PILOT SHAFT STEM TRIAL THREADS ARE WORN. NO ADDITIONAL SURGERY TIME REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15064502 ↗
• MalfunctionFeb 5, 2018Component Missing; Component Missing

  AT STERILIZATION, THEY NOTICED THAT A PIECE WAS MISSING, THE PIN THAT HOLDS THE SCREWED END IN PLACE. PATIENT CONSEQUENCE? :NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7240464 ↗
• InjuryNov 28, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PROCEDURE: TOTAL HIP REPLACEMENT. DURING THE PROCEDURE, THE S-ROM TRIANGLE MILLER HANDLE WAS BROKEN BY THE SURGEON DURING ATTEMPTS TO REMOVE A MILLER SHELL AND SHAFT PILOT THAT HAD BECOME "STUCK" INSIDE THE FEMORAL CANAL. IT IS UNCLEAR AS TO WHY THE MILLER SHELL AND SHAFT PILOT HAD BECOME STUCK, BUT A SMALL FEMORAL FRACTURE OCCURRED WHILST ATTEMPTING TO REMOVE THE "STUCK" INSTRUMENTS. THIS WAS RECTIFIED INTRA-OPERATIVELY BY THE SURGEON BY PLACING A CERCLAGE CABLE AROUND PROXIMAL PORTION OF THE FRACTURED FEMUR. FEMALE PATIENT ID (B)(6), INITIALS (B)(6). ACTION TAKEN: A SLAP HAMMER EXTRACTION DEVICE WAS USED TO REMOVE THE "STUCK" INSTRUMENTS, FOLLOWING WHICH THE CASE WAS COMPLETED. IT WAS ALSO NOTED DAMAGE TO ONE OF THE 20X15 S-ROM SHAFT PILOTS (REPORTED ABOVE) INCLUDED IN THIS KIT, BUT IT IS UNCLEAR AS TO WHEN OR HOW THAT DAMAGE OCCURRED?

  Patient problems: Hip Fracture

  MAUDE report 7065947 ↗