SMS Stem 01.36.165Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630345701879), received between Jul 4, 2025 and Nov 18, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ON (B)(6) 2025, THE PATIENT HAD PRIMARY LEFT HIP SURGERY USING A MEDACTA HEAD AND STEM. A COMPETITOR'S LINER WAS USED. ON 20 (B)(6) 2025, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD AND REVISED THE COMPETITOR LINER WITH A COMPETITOR LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN DUE TO INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA HEAD AND STEM WITH A MEDACTA HEAD AND STEM. THE SURGEON REVISED THE COMPETITOR LINER WITH A COMPETITOR LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23579960 ↗
• InjuryJul 4, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT 1 YEAR FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED STEM, HEAD, AND LINER AND ALSO IMPLANTED A DM COVERTER. SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22402969 ↗