S-ROM 2576-05-023Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295145554), received between Sep 25, 2018 and Nov 20, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2024Material Deformation; Material Deformation

  IT WAS REPORTED, THAT THE PATIENT UNDERWENT A TOTAL HIP REPLACEMENT. THE MILLER FRAME SIZING RING INDICATORS WERE BENT, DUE TO SURGEON IMPACTING. THERE WAS NO ADDITIONAL SURGERY TIME REQUIRED. AND THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20736665 ↗
• MalfunctionJul 17, 2023Break; Break

  IT WAS REPORTED THAT INSTRUMENT BROKE WHILE TAKING IT OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17333750 ↗
• MalfunctionJul 16, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT HE DO NOT KNOW WHEN THIS HAPPENED STERILE SERVICES GAVE TO SALES REP WHEN THE REP WAS CHECKING INSTRUMENTS AND SAID IT WAS BROKEN. DID NOT HAPPEN DURING SURGERY. THE RINGS ON THE INSTRUMENT ARE BENT AND THE SCREWS HEADS ARE OFF ONE SIDE NEEDS TO BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10283344 ↗
• MalfunctionMar 30, 2020Illegible Information; Illegible Information

  IT WAS REPORTED THAT SROM INSTRUMENTS ARE DIFFICULT OR IMPOSSIBLE TO READ THE SIZING. SURGEON IS CONCERNED THIS IS A PATIENT SAFETY ISSUE AND INSTRUMENTS SHOULD BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9900570 ↗
• MalfunctionFeb 20, 2020Material Twisted/Bent; Illegible Information; Material Twisted/Bent; Illegible Information

  IT WAS REPORTED THAT THE INSTRUMENT WERE DIFFICULT OR IMPOSSIBLE TO READ ETCHING DUE TO WEAR AND TEAR OVER THE YEARS. THE SURGEON IS CONCERNED ABOUT THE PATIENT SAFETY ISSUE AND THE INSTRUMENTS NEED TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9732484 ↗
• MalfunctionSep 25, 2018Break; Break

  IT WAS REPORTED THAT THE SROM CALCAR MILLER FRAME WAS BROKEN, THE 16F PORTION BROKE OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7908414 ↗