S-ROM 52-3396Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295171027), received between Apr 30, 2026 and Apr 30, 2026 — classified as 1 injury.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAD THERE HIP REPLACED OVER 25 YEARS AGO BY DOCTOR WHERE HE IMPLANTED A SROM STEM WITH A STRYKER VITALOC CUP. THE PATIENT DID WELL UNTIL RECENTLY WHEN THEIR HIP BECAME UNSTABLE DUE TO POLYETHYLENE WEAR WITH THE STRYKER CUP. THE SROM HIP BALL AND STEM WERE EXPLANTED TO FACILITATE EXPOSURE TO THE ACETABULAR CUP. THE CUP WAS THE EXPLANTED AND A NEW ACETABULAR CUP WAS IMPLANTED. THE SROM SLEEVE WAS LEFT IN SITU AND A NEW SROM HIP BALL AND STEM WERE IMPLANTED BACK INTO THE EXISTING SLEEVE. UNFORTUNATELY THE LOTT # INFORMATION FOR THE STEM AND HIP BALL WERE NOT VISIBLE AND COULD NOT BE RECORDED. ACTIVITY LEVEL - YES. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 25048950 ↗