SMS Stem 01.36.070Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030888823), received between Dec 28, 2021 and Feb 24, 2026 — classified as 5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2026Fracture

  REVISION SURGERY ABOUT 2 WEEKS POST OP DUE TO FEMUR BONE FRACTURE. STEM AND HEAD REVISED SUCCESSFULLY. THE SURGEON REPORTED THAT THE FRACTURE IS LIKELY DUE TO A POOR BONE QUALITY OF THE PATIENT ASSOCIATED WITH A VARUS MORPHOLOGY OF THE FEMUR.

  Patient problems: Medical device site infection

  MAUDE report 24429840 ↗
• InjuryAug 22, 2023No Apparent Adverse Event; No Apparent Adverse Event

  REVISION DUE TO PERIPROSTHETIC BONE FEMORAL FRACTURE, AT ABOUT 5 DAYS POST PRIMARY. IT IS UNKNOWN IF A TRAUMATIC EVENT OCCURRED. A QUADRA STEM HAS BEEN IMPLANTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 17594766 ↗
• InjuryJun 16, 2023No Apparent Adverse Event; No Apparent Adverse Event

  DURING THE SURGERY, THE IMPLANT SUBSIDED AND THE POST-OP CT SCANS SHOWED A BONE FRACTURE. NO REVISION SURGERY HAS BEEN PLANNED AND THE SURGEON IS MONITORING THE PATIENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 17144077 ↗
• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem

  AT 2 WEEKS AFTER THE PRIMARY SURGERY, THE PATIENT FEMORAL BONE FRACTURED. THE FEMUR FRACTURE WAS NOT SEEN DURING SURGERY. THE SURGEON CABLED IN PRIMARY ONLY BECAUSE THE STEM WAS UPSIZED. THE FRACTURE WAS ONLY SEEN 2 WEEKS POST-OP. THE SURGEON IS NOT PLANNING TO REVISE.

  Patient problems: Hip Fracture

  MAUDE report 14191935 ↗
• InjuryDec 28, 2021Appropriate Device Problem Term/Code Not Available

  DURING THE PRIMARY HIP SURGERY, THE SURGEON OBSERVED THAT A FEMUR FRACTURE HAD OCCURRED INTRAOPERATIVELY, WHEN IMPLANTING THE STEM, AND THE CAUSE IS UNKNOWN. THE SURGEON USED THE IMPACTOR/INSERTER DEDICATED FOR SMS. THE SURGEON REVISED THE SMS SOLID STEM LAT SIZE 10 WITH A QUADRA-P COLLARED LAT. SIZE 5 AND CABLED THE FRACTURE. THE BONE QUALITY WAS EXCELLENT, TYPE A FEMPUR. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 13091642 ↗