S-ROM 2576-09-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295146018), received between Aug 6, 2020 and Jul 23, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 23, 2025Break; Break

  IT WAS REPORTED THAT THE STEM TRIAL WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22578198 ↗
• MalfunctionMay 23, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT UPON INSPECTION OF THE SROM INSTRUMENTS BEFORE OUR NEXT SROM HIP REPLACEMENT, IT WAS DISCOVERED THAT THE 9MM STEM TRIAL IN THE AUXILIARY INSTRUMENT SET WAS BENT MAKING IT UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16983107 ↗
• MalfunctionAug 19, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE THREAD ON 9X14 STEM TRIAL WOULD NOT FULLY ENGAGE WITH NECK TRIAL. THREAD APPEARS TO BE DAMAGED. STEM TRIAL ALSO SLIGHTLY BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15258641 ↗
• MalfunctionJun 2, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SROM TRIAL STEM SLIGHTLY BENT. THIS WAS NOTICED IN SPD AND WAS NOT USED IN A CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14572126 ↗
• MalfunctionApr 13, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE SURGERY WAS DELAYED FOR AT LEAST 30 MINUTES. THE PATIENT HAD A GOOD OUTCOME. LOT NUMBERS ARE UNAVAILABLE; HOWEVER, AFFECTED TRIALS WERE SENT BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11657023 ↗
• MalfunctionAug 21, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SROM 9 MMX150 MM IS BENT/BOWED. NO TIME WAS ADDED TO THE CASE. THE PATIENT'S OUTCOME AND RESULT OF THE CASE WAS NOT IMPACTED.

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

  MAUDE report 10437198 ↗
• MalfunctionAug 6, 2020Naturally Worn; Naturally Worn

  PLEASE REPLACE WORN TRIAL COMPONENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10375209 ↗