S-ROM 2365-31-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295120032), received between Aug 21, 2017 and Apr 20, 2026 — classified as 8 malfunctions.

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

• MalfunctionApr 20, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT. PRODUCT HAD REACHED END OF LIFE DUE TO WEAR AND TEAR. THE SURGEONS WERE COMPLAINING ABOUT INSTRUMENT BEING DULL, ILLEGIBLE, AND GENERALLY WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926354 ↗
• MalfunctionFeb 16, 2023Device-Device Incompatibility; Illegible Information; Device-Device Incompatibility; Illegible Information

  IT WAS REPORTED THE TRIALS WOULD NOT STAY ON THE NECK TRIAL. NO SURGICAL DELAY WAS THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16385846 ↗
• MalfunctionJan 27, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE TRIAL HEADS SHOW SIGNIFICANT WEAR DUE TO MULTIPLE USES AND NEED TO BE REPLACED. THE SALES REP BECAME AWARE OF THIS ON (B)(6) 2023, WHILE SETTING UP FOR THE PROCEDURE. FOUND TEMPORARY REPLACEMENTS FOR THIS SURGERY. LOT NUMBER COULD NOT BE READ ON THE 32MM +0. NO SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16253497 ↗
• MalfunctionDec 8, 2022Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT ON THE 36+12 SROM NECK TRIAL, THE SCREW-IN PIECE THAT CONNECTS TO THE DISTAL STEM STRIPPED. ALSO, THE 36+0 HEAD TRIAL WAS VERY LOOSE ON THE TRIAL NECK TRUNNION. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15940618 ↗
• MalfunctionJan 2, 2020Scratched Material; Scratched Material

  TRIAL HEAD IS DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9539534 ↗
• MalfunctionAug 2, 2019Scratched Material; Scratched Material

  IT WAS REPORTED THAT DEEP CUTS AND GOUGES FOUND WHEN SET RETURNED TO THE OFFICE FOR INSPECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8855380 ↗
• MalfunctionAug 8, 2018Scratched Material; Scratched Material

  GENERAL WEAR, SCRATCHES ON HEAD MAKING IT DIFFICULT TO READ.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7761444 ↗
• MalfunctionAug 21, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT HEAD TRIALS WERE FOUND TO HAVE DEEP GOUGES UPON POST SURGICAL OBSERVATION. IT WAS ALSO STATED THAT THE SURFACES ARE DAMAGED.

  Patient problems: No Information

  MAUDE report 6808253 ↗