S-ROM 87-5928Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295218807), received between Aug 2, 2019 and Feb 6, 2025 — classified as 6 malfunctions.

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

• MalfunctionFeb 6, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TOTAL HIP, EXTRACTION OF STEM SLAP HAMMER SHAFT BENT. IT WAS UNKNOWN IF THE SURGERY WAS DELAYED OR IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21323000 ↗
• MalfunctionMay 24, 2024Break; Peeled/Delaminated; Break; Peeled/Delaminated

  IT WAS REPORTED THAT THE TRIAL HEAD IS TOO DAMAGED TO BE USED. NO DELAY TO SURGERY. PATIENT NOT COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19390297 ↗
• 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 16253500 ↗
• MalfunctionApr 3, 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 9919390 ↗
• MalfunctionFeb 19, 2020Material Twisted/Bent; Material Twisted/Bent

  CALL FROM THE HOSPITAL TO REPLACE 3 INSTRUMENTS DUE TO WEAR AND TEAR PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9728678 ↗
• MalfunctionAug 2, 2019Display Difficult to Read; Scratched Material; Display Difficult to Read; 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 8855374 ↗