Anatomic Shoulder Prosthesis 04.01.0026Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630040712644), received between Feb 21, 2025 and May 12, 2026 — classified as 2 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 5 YEARS 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING PERSISTENT PAIN AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA OR BONE QUALITY ISSUES. THE SURGEON REVISED THE ANATOMICAL SHOULDER TO A REVERSE SHOULDER SYSTEM, LEAVING THE DIAPHYSIS IMPLANTED FROM THE PRIMARY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 25148957 ↗
• InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2024. ON (B)(6) 2024, WHILE IN PHYSICAL THERAPY, IT WAS OBSERVED THAT THE BASEPLATE CUT OUT POSTERIORLY AND THE CAUSE IS UNKNOWN. THE SURGEON CONVERTED THE PATIENT FROM A REVERSE TO A HEMI. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2025, THE PATIENT HAS BEEN REPORTING PAIN AND LACK OF RANGE OF MOTION TO THE SURGEON. THE SURGEON HAS REQUESTED A CUSTOM GLENOID BASEPLATE TO ALLEVIATE THE PATIENT'S PAIN. THE PATIENT WILL UNDERGO A 2ND REVISION SURGERY.

  Patient problems: Loss of Range of Motion

  MAUDE report 21432768 ↗

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