Anatomic Shoulder Prosthesis 04.01.0004Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630040706032), received between Feb 22, 2018 and Aug 26, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

1 other recall cover devices cleared under the same FDA submission (K170910); they may or may not involve this specific model.

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 18, 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.

• InjuryAug 26, 2025Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY AT ABOUT 4 YEARS AND 9 MONTHS FROM PRIMARY DUE TO PROXIMAL STEM LOOSENING. THE SURGEON REVISED ALL COMPONENTS TO COMPETITOR COMPONENTS, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 22892575 ↗
• InjuryApr 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY AT ABOUT 1 YEAR AND 4 MONTHS POST PRIMARY THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 21771299 ↗
• InjuryNov 22, 2023Loss of Osseointegration; Loss of Osseointegration

  AT 3 WEEKS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM THAT CHANGED ROTATION. THE SURGEON REVISED THE LINER, METAPHYSIS AND DIAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18194079 ↗
• InjuryDec 16, 2020Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated

  REVISION SURGERY PERFORMED 2 MONTHS AFTER THE PRIMARY SURGERY DUE TO IMPLANT DISLOCATION (LINER FORM GLENOSPHERE). THE DISLOCATION OCCURRED DUE TO THE STEM RETROVERSION (25-30 DEGREES OVER THE DESIRED POSITION) AND OVERSIZING OF THE STEM. THE STEM, METAPHYSIS, INLAY AND GLENOSPHERE WERE REVISED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 11019536 ↗
• InjuryFeb 22, 2018Migration or Expulsion of Device

  STEM SUBSIDENCE AFTER ABOUT 6 WEEKS FROM TOTAL SHOULDER REPLACEMENT; REVISION SURGERY PLANNED FOR (B)(6) 2018.

  Patient problems: Joint Disorder

  MAUDE report 7288851 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170910. One submission often covers many models, so check the product and lot details in each record.

• Z-0775-2020 · Nov 4, 2019 · Terminated
  Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic Shoulder Prosthesis is indicated for treat