SMS Stem 01.36.071Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030888830), received between Sep 23, 2020 and Jan 10, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2024Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY FOR STEM LOOSENING AT ABOUT 9 MONTHS POST-PRIMARY. STEM AND HEAD SUCCESSFULLY REVISED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18482244 ↗
• InjuryApr 26, 2023Osseointegration Problem; Osseointegration Problem

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE AND SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THE LOOSENING HAPPENED BEFORE THE SUBSIDENCE. AT ABOUT 5 MONTHS POST PRIMARY THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16813624 ↗
• InjurySep 23, 2020Osseointegration Problem; Osseointegration Problem

  4 MONTHS AFTER THE PRIMARY SURGERY, DUE TO PERIPROSTHETIC FRACTURE WHICH WAS CAUSED FROM FALLING, THE PATIENT WAS REVISED. THE SURGEON CABLED THE FRACTURE AND REVISED THE HEAD, STEM, AND LINER. NOW, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMORAL STEM 7 MONTHS AFTER THE FIRST REVISION SURGERY. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 10572823 ↗