SMS Stem 01.36.044Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030888632), received between Mar 5, 2021 and Aug 27, 2025 — classified as 6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO A LEG LENGTH DISCREPANCY. ABOUT 2 WEEKS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE STEM, HEAD AND LINER. THE PATIENT WAS LONG BY 6MM; DOWNSIZING THE HEAD WOULD NOT BE ENOUGH; HE HAD TO DOWNSIZE THE STEM TO ADDRESS THE LENGTH. THE STEM WAS DOWNSIZED AND REVISED WITH THE SAME SIZE LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unequal Limb Length

  MAUDE report 22902786 ↗
• InjuryMar 14, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT 1 YEAR 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21604382 ↗
• InjuryOct 27, 2023Osseointegration Problem; Osseointegration Problem

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2021. ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A NEW MEDACTA STEM AND HEAD AND REVISED THE CUP AND LINER WITH A COMPETITOR CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18018914 ↗
• InjuryMay 16, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 3 WEEKS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC BONE FRACTURE AND THE CAUSE IS UNKNOWN. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 16938633 ↗
• InjuryJul 22, 2021Fracture

  THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE AND THE CAUSE OF THE PERIPROSTHETIC FRACTURE IS UNKNOWN. THE SURGEON CABLED THE FRACTURE AND REVISED THE HEAD AND STEM 3 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 12211788 ↗
• InjuryMar 5, 2021Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY 1 YEAR AND 2 MONTHS AFTER PRIMARY. THE PATIENT HAD A LOT OF PAIN AND DURING THE SURGERY THE STEM CAME OUT EASILY. STEM AND HEAD REVISED SUCCESSFULLY. THE SURGEON THINKS THAT THE REASON OF REVISION IS LOOSENING OF THE STEM.

  Patient problems: Pain

  MAUDE report 11421677 ↗