SMS Stem 01.36.048Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030888670), received between Apr 8, 2020 and Sep 16, 2026 — classified as 5 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. 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.

• InjurySep 16, 2026Migration or Expulsion of Device

  The patient came in presenting pain due to a fracture and subsided stem and the cause is unknown. About 2 years and 9 months after the primary surgery, the surgeon revised the stem and head. Patient`s bone quality good (65 years old), the fracture was already healed at the time of the revision. M-vizion stem implanted.

  Patient problems: Bone Fracture(s); Implant Pain

  MAUDE report 50784460 ↗
• InjuryMay 12, 2026Device Appears to Trigger Rejection

  AT ABOUT 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE SMS SOLID STEM SIZE8 TO AN AMISTEM-C SIZE3, REVISED THE 28MM BIOLOX HEAD L TO A 40MM BIOLOX HEAD XL, AND REVISED THE D 28/DMF DOUBLE MOBILITY LINER TO A FACE CHANGING 10° HC LINER D 40/G. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25148979 ↗
• InjuryFeb 23, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 3 MONTHS FROM 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 ALL MEDACTA COMPONENTS WITH COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18765736 ↗
• InjuryAug 7, 2023Migration; Migration

  AT ABOUT 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM. THE SURGEON REVISED SUCCESSFULLY THE HEAD AND STEM.

  Patient problems: Implant Pain

  MAUDE report 17468214 ↗
• InjuryApr 8, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A SUBSIDED STEM. ABOUT 1 MONTH AFTER PRIMARY SURGERY THE SURGEON REVISED THE STEM AND CERAMIC HEAD SUCCESSFULLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON SUSPECTS THAT THE SUBSIDENCE OCCURED DUE TO AN UNDERSIZED STEM BEING IMPLANTED DURING THE PRIMARY.

  Patient problems: Joint Disorder

  MAUDE report 9937359 ↗