SMS Stem 01.36.047Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07630030888663), received between Jul 10, 2020 and Mar 31, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO PERIPROSTHETIC FEMUR FRACTURE 1 MONTH AFTER PRIMARY SURGERY. THE SURGEON CABLED THE FRACTURE AND REVISED THE SMS SOLID STEM TO AN AMISTEM P COLLARED SIZE5 STEM, THE D 28 DM LINER TO A SAME SIZE LINER, AND THE 20MM BIOLOX M HEAD TO A 28MM BIOLOX S HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 24738816 ↗
• InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY AT ABOUT 9 MONTHS POST PRIMARY DUE TO STEM SUBSIDENCE, CAUSING LEG LENGHT DISCREPANCY. STEM NOT REVISED. HEAD AND LINER REVISED SUCCESSFULLY AND LEG LENGHT CORRECTED.

  Patient problems: Unequal Limb Length

  MAUDE report 19971303 ↗
• InjuryFeb 15, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ABOUT 1 WEEK AFTER THE PRIMARY SURGERY, THE SURGEON NOTED A FEMORAL FRACTURE ON CT SCANS. IT IS UNKNOWN HOW THE FRACTURE OCCURRED. OSTEOSYNTHESIS WAS PERFORMED WITH NESPRON TAPE AND THE STEM WAS NOT REVISED.

  Patient problems: Bone Fracture(s)

  MAUDE report 16377687 ↗
• InjuryFeb 8, 2023Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY ON BILATERAL PATIENT AT ABOUT 1 YEAR 7 MONTHS AFTER THE PRIMARY DUE TO ASEPTIC INSUFFICIENT OSTEOINTEGRATION OF THE SMS SOLID STEM. NO INFECTION DETECTED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16322734 ↗
• InjuryOct 25, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  REVISION SURGERY 3 MONTHS AFTER PRIMARY DUE TO STEM SUBSIDENCE. STEM LOOSENING, OSTEOLYSIS AND FRACTURE WERE FOUND ON THE FEMUR.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12688347 ↗
• InjuryMay 11, 2021Osseointegration Problem; Osseointegration Problem

  3 WEEKS AFTER THE PRIMARY SURGERY LOOSENING OF THE STEM THAT WAS LIKELY UNDERSIZED DURING PRIMARY SURGERY. THE SURGEON REVISED SUCCESSFULLY STEM, HEAD AND LINER.

  Patient problems: Failure of Implant

  MAUDE report 11805082 ↗
• InjuryJul 10, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  CRACK DETECTED AT THE CALCAR 1 MONTH AFTER THE PRIMARY SURGERY ((B)(6) 2020). IN JUNE THE SURGEON NOTICED AN OSSIFICATION ON THE CRACK ( BONE GROWTH). THE STEM WAS MOBILIZED AND THE MOBILIZATION OCCURRED BEFORE THE CRACK. ON (B)(6) 2020 THE SURGEON PERFORMED A PUNCTURE. REVISION SURGERY OF ALL IMPLANTS PERFORMED ON (B)(6) 2020.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 10256655 ↗