SMS Stem 01.36.045Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030888649), received between Oct 2, 2019 and Jul 8, 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.

• InjuryJul 8, 2026Fracture

  REVISION SURGERY DUE TO A PERIPROSTHETIC FRACTURE AFTER ABOUT 2 YEARS AND 2 MONTHS FROM PRIMARY SURGERY. THE SURGEON CABLED THE FRACTURE AND REVISED THE MEDACTA HEAD AND STEM TO A COMPETITOR HEAD AND STEM. THE SURGEON ALSO REVISED THE D 36/E HOODED PE HC LINER TO A D 36/E FLAT PE HC LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 25747725 ↗
• InjuryJan 27, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM 3 MONTHS AFTER THE PRIMARY. THE SURGEON REVISED THE HEAD WITH A LONGER HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 16253519 ↗
• InjuryAug 22, 2022Migration; Migration

  AT 16 DAYS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 15265024 ↗
• InjuryAug 27, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM. THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. THE SURGEON REVISED THE HEAD, STEM, AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 10458499 ↗
• InjuryOct 2, 2019Loose or Intermittent Connection

  THE PATIENT CAME IN, 3 MONTHS AFTER PRIMARY SURGERY, COMPLAINING OF PAIN DUE TO A SUBSIDED STEM. THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. THE SURGEON REVISED THE MEDACTA SMS SOLID STEM (B)(6) WITH A MEDACTA MINIMAX STEM - SIZE 5 LEFT, AND REVISED THE MEDACTA 36MM BIOLOX DELTA HEAD S WITH A MEDACTA 36MM BIOLOX DELTA HEAD S. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9144402 ↗