SMS Stem 01.36.051Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030888700), received between Jul 14, 2020 and Mar 30, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY DUE TO STEM LOOSENING ABOUT 3 YEARS AND 11 MONTHS AFTER PRIMARY SURGERY.THERE WAS NO INDICATION OF TRAUMA. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD. THE SURGEON ALSO REVISED THE MEDACTA LINER TO A SAME SIZE MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 24711051 ↗
• InjuryMar 6, 2024Fracture; Fracture

  AT ABOUT 2 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC BONE FRACTURE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. IT HAS BEEN REPORTED A GOOD BONE QUALITY.

  Patient problems: Bone Fracture(s)

  MAUDE report 18847130 ↗
• InjuryJan 4, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN FEW DAYS AFTER THE PRIMARY SURGERY REPORTING INSTABILITY DUE TO A LEG LENGTH DISCREPANCY AND THE CAUSE OF THE LEG LENGTH DISCREPANCY IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unequal Limb Length

  MAUDE report 13153122 ↗
• InjuryJul 14, 2020Appropriate Device Problem Term/Code Not Available

  3 MONTHS AFTER PRIMARY REVISION SURGERY NECESSARY FOR A PATIENT WHO HAD PRIMARY HIP SURGERY ON THE (B)(6) 2020. THE REASON OF REVISION IS UNDER INVESTIGATION.

  Patient problems: No Code Available

  MAUDE report 10270326 ↗