S-ROM 2576-18-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295146599), received between Sep 6, 2017 and Jun 3, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Illegible Information” (6 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026Material Deformation

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT. BURRS HAD DEVELOPED ON THE INSIDE OF THE TRIAL SLEEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25375178 ↗
• MalfunctionMay 7, 2026Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SLEEVE WAS BEAT UP AT THE BOTTOM AND WAS DIFFICULT TO EXTRACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25116552 ↗
• MalfunctionMar 24, 2026Illegible Information

  IT WAS REPORTED THAT THE TOPS OF THE SLEEVE TRIALS HAVE THE SIZES SCRAPED OFF. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681577 ↗
• MalfunctionDec 1, 2025Material Deformation; Mechanical Jam; Illegible Information; Material Deformation; Mechanical Jam; Illegible Information

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT PROCEDURE IT WAS OBSERVED THAT THE BOTTOM OF TRIAL WAS WARPED AND WAS HARD TO REMOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23688886 ↗
• MalfunctionOct 31, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT. SLEEVE TRIAL WAS WARPED AT THE BOTTOM MAKING IT DIFFICULT TO EXTRACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439134 ↗
• MalfunctionJun 13, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SLEEVE TRIAL IS WARPED ON THE BOTTOM AND IT WOULD DIFFICULT TO EXTRACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22204022 ↗
• MalfunctionJul 26, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT, SLEEVE TRIALS WERE WORN DOWN AND NOT EASILY EXTRACTED FROM FEMUR. SURGEON REQUESTED FOR REPLACEMENT. LOT NUMBER NOT AVAILABLE DUE TO WEAR. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15101846 ↗
• MalfunctionJun 13, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT SLEEVE TRIAL IS WORN. LOT NUMBER IS WORN .THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14676238 ↗
• MalfunctionJun 13, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE SLEEVE TRIALS ARE NOT EASILY EXTRACTED FROM FEMUR FOR REPEATED USE AND WEAR. SURGEON HAS REQUESTED THEY BE REPLACED. LOT NUMBERS NOT AVAILABLE DUE TO WEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14675431 ↗
• MalfunctionJun 13, 2022Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE TRIAL SLEEVE IS DIFFICULT TO EXTRACT AND THE LOT NUMBER IS ILLEGIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14674400 ↗
• MalfunctionApr 1, 2020Scratched Material; Illegible Information; Scratched Material; Illegible Information

  IT WAS REPORTED THAT THE SROM SLEEVES CAN¿T BE READ OR USED AND ARE DAMAGED. CAN¿T READ LOT NUMBERS SO DON¿T ASK FOR THEM. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9912526 ↗
• MalfunctionFeb 27, 2020Material Twisted/Bent; Illegible Information; Material Twisted/Bent; Illegible Information

  IT WAS REPORTED THAT THE S-ROM SLEEVE TRIALS ARE DIFFICULT TO IMPOSSIBLE TO READ SIZING DUE TO WEAR AND TEAR AND NORMAL EVERYDAY USE. THE NEED TO BE REPLACED SO THAT THE SURGEON IS ABLE TO SAFELY DETERMINE THE SIZE OF THE TRIAL BEING USED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9765923 ↗
• MalfunctionFeb 25, 2020Material Twisted/Bent; Illegible Information; Material Twisted/Bent; Illegible Information

  IT WAS REPORTED THAT THE S-ROM SLEEVE TRIALS ARE EITHER DIFFICULT TO IMPOSSIBLE TO READ THE SIZE. THIS IS A SAFETY CONCERN FOR THE SURGEON WHO CAN'T EASILY DETERMINE THE SIZE OF THE TRIAL SLEEVE BEING INSERTED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9752890 ↗
• MalfunctionOct 23, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT THE SLEEVES TRIALS DISTAL EDGE HAS WORN AND CANNOT BE EXPLANTED EASILY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9226285 ↗
• MalfunctionOct 23, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT THE SLEEVES TRIALS DISTAL EDGE HAS WORN AND CANNOT BE EXPLANTED EASILY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9226283 ↗
• MalfunctionSep 12, 2019Material Twisted/Bent; Scratched Material; Material Twisted/Bent; Scratched Material

  IT WAS REPORTED THAT THE SLEEVES TRIALS HAVE BENT THE EDGE AROUND THE BOTTOM AND THE SLEEVE EXTRACTOR DOESN'T HAVE ANYTHING TO GRAB ON TO. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9010394 ↗
• MalfunctionMar 7, 2019Connection Problem; Material Twisted/Bent; Mechanical Jam; Scratched Material; Connection Problem; Material Twisted/Bent; Mechanical Jam; Scratched Material

  IT WAS REPORTED THAT THE 18 B LARGE SROM SLEEVE TRIAL NEEDS TO BE REPLACED BECAUSE IT WAS STICKING TO THE INSERTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8402365 ↗
• MalfunctionDec 11, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ALL OF THE 10 SROM INSTRUMENTS WERE DEEMED TO BE UNUSABLE BEACUSE THE SIZE MARKINGS ARE NO LONGER VISIBLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7104931 ↗
• MalfunctionSep 6, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT SROM SLEEVE TRIAL HAS BECOME WORN AND NOT LEGIBLE.

  Patient problems: No Information

  MAUDE report 6846325 ↗