S-ROM 2576-30-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295147039), received between Apr 18, 2018 and Nov 17, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT REAMER SHAFT WOULD NOT FIT INTO THE REAMER ADAPTER, AND IT LOOKED BENT. IT WAS FURTHER OBSERVED THAT THE NECK TRIAL AND STEM TRIAL WOULD NOT SCREW TOGETHER AND SEEM TO BE STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576013 ↗
• MalfunctionMar 16, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 30 STD NECK NO LONGER LOCKS ONTO STEM TRIALS. IT JUST SPINS ON THE STEM TRIAL. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16554084 ↗
• MalfunctionApr 13, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT WHILE SURGERY WAS TAKING PLACE, THE PRODUCTS LISTED BELOW WERE ALL TRIALED AND SHOWED SIGNS OF DYSFUNCTION. NEITHER THE BODIES OR THE STEMS WOULD FULLY LOCKED DOWN AND CONNECT TO EACH OTHER. SOME OF THE BODY SHOWED SIGNS OF THREADED THREADS. SURGERY WAS DELAYED. THERE WERE NO PARTS BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11657122 ↗
• MalfunctionAug 31, 2020Material Twisted/Bent; Material Twisted/Bent

  THIS EVENT OCCURRED DURING "SALES TRAINING"; SA LOAN INSTRUMENT KIT = BROKEN INSTRUMENT. STANDARD NECK TRIAL FROM THE SROM INSTRUMENT LOAN KIT IS CROSS THREADING AND A REPLACEMENT IS REQUIRED PLEASE. ITEM: D25763000; LOT: MT0606 (CORRECT).

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10471803 ↗
• MalfunctionFeb 25, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE TRIAL NECK DOES NOT ENGAGE WITH THE STEM. NEEDS REPLACEMENT TO LEYVA'S WH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9752118 ↗
• MalfunctionDec 9, 2019Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn; Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn

  30 STD TRIAL WOULD NOT THREAD.

  Patient problems: Not Applicable

  MAUDE report 9439141 ↗
• MalfunctionSep 7, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE NECK WON¿T TIGHTEN TO STEM. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7854950 ↗
• MalfunctionApr 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPACTOR HANDLE CRACKED AFTER YEARS OF USE. THE TWO NECK TRIALS ALSO STRIPPED AND IT WILL NOT STAY ON THE STEM TRIAL. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7439420 ↗