S-ROM 2576-00-016Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295145318), received between Apr 8, 2020 and Jan 7, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE TRIAL SLEEVE REMOVER WAS NOT HOOKING ON THE TRIAL SLEEVE. POSSIBLY WORN OR BROKEN? WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> UNKNOWN, WERE FRAGMENTS GENERATED? --> UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> , WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23993570 ↗
• MalfunctionDec 3, 2025Device-Device Incompatibility; Material Deformation; Illegible Information; Device-Device Incompatibility; Material Deformation; Illegible Information

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGICAL PROCEDURE IT WAS OBSERVED THAT THE BOTTOM OF TRIAL WAS WARPED PREVENTING IT FROM BEING ABLE TO BE PULLED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707288 ↗
• MalfunctionSep 7, 2021Naturally Worn; Naturally Worn

  COMPASS CASE (B)(4) REPORTS: IT WAS REPORTED THAT THE EXTRACTION TIP WAS WORN OUT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12433378 ↗
• MalfunctionApr 8, 2020Scratched Material; Illegible Information; Scratched Material; Illegible Information

  IT WAS REPORTED THAT THE INSTRUMENTS ARE SCRATCHED UP OR DAMAGED AND SIZES CAN¿T BE READ OR IDENTIFIED EASILY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9940078 ↗