Anatomic Shoulder Prosthesis 04.01.0006Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630040706056), received between May 30, 2018 and Sep 9, 2025 — classified as 1 death, 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathSep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2025 (B)(6) MEDICAL CENTER. ON (B)(6) 2025 REVISION SURGERY PERFORMED. THE PATIENT CAME IN REPORTING PAIN AFTER FALLING AND LANDING ON THE SHOULDER, LEADING TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED ONLY THE LINER (0 MM TO 6 MM). SOMETIME IN MID-(B)(6) 2025, THE PATIENT PASSED AWAY DUE TO HEART FAILURE. NO ISSUE WITH MEDACTA DEVICES.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 23001781 ↗
• InjuryDec 20, 2018Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO INFECTION 3 WEEKS AFTER THE PRIMARY SURGERY. THE SURGEON REVISED THE METAPHYSIS, HUMERAL STEM AND INLAY.

  Patient problems: Unspecified Infection

  MAUDE report 8184351 ↗
• InjuryMay 30, 2018Device Dislodged or Dislocated

  THE PATIENT CAME IN COMPLAINING OF PAIN 18 DAYS AFTER PRIMARY. THE SURGEON DETERMINED THAT THE PATIENT HAD DISLOCATED. THE CAUSE OF DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE DIAPHYSIS, METAPHYSIS, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 7552096 ↗

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