S-ROM 87-5920Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295218777), received between May 24, 2018 and Apr 26, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  INSTRUMENT STUCK INSIDE OF ANOTHER INSTRUMENT. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19197483 ↗
• MalfunctionJan 8, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE SURGEON LOST THE TRIAL HIP BALL IN THE PATIENT¿S PELVIS AND WAS UNABLE TO RETRIEVE IT.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18465032 ↗
• 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 16253499 ↗
• 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 8855384 ↗
• MalfunctionMay 24, 2018Material Deformation; Material Deformation

  (B)(6) HOSPITAL (B)(6) 2018. PINNACLE CUP IMPACTOR THREAD DAMAGED, UNABLE TO PUT A CUP ON THE HANDLE REQUIRES REPLACEMENT SROM 28+0 HEAD DAMAGED. NO AE TO PATIENT. NO DELAY TO PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7540713 ↗