SMS Stem 01.36.144Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630345701718), received between Jun 4, 2025 and May 26, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Osseointegrate” (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 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.

• MalfunctionMay 26, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AT APPROXIMATELY 2 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT EXPERIENCED IMPLANT LOOSENING. NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: Aseptic loosening

  MAUDE report 25275479 ↗
• InjuryNov 4, 2025Failure to Osseointegrate; Failure to Osseointegrate

  AFTER 1 YEAR AND 5 MONTHS, THE PATIENT PRESENTED WITH PAIN OF UNKNOWN CAUSE. THE SURGEON DETERMINED THERE WAS ASEPTIC LOOSENING OF THE FEMORAL COMPONENT AND REVISED THE HEAD AND LINER, UPSIZING THE STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 23461660 ↗
• InjuryJun 4, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT 5 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA HEAD AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22138796 ↗