Anatomic Shoulder Prosthesis 04.01.0130Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630040713252), received between Mar 9, 2021 and Oct 18, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Malposition of Device” (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 16, 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.

• InjuryOct 18, 2023Malposition of Device; Malposition of Device

  AT ABOUT 1 YEAR AND 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE WAS UNKNOWN. AFTER REVIEWING X-RAYS, THE SURGEON NOTICED THAT THE GLENOID WAS NOT POSITIONED CORRECTLY. PARTICULARLY, THE SURGEON COMMENTED THAT HE DID NOT PUT THE GLENOID IN THE POSITION THAT HE WOULD HAVE PREFERRED DURING THE PRIMARY. THE SURGEON REVISED ALL IMPLANTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 17956404 ↗
• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN DUE TO A FAILED SUBSCAPULARIS MUSCLE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE ANATOMIC HEAD, DOUBLE ECCENTER, POLY, AND ANATOMIC METAPHYSIS 9 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 14488699 ↗
• InjuryMar 9, 2021Unstable

  REVISION SURGERY DUE TO INSTABILITY 8 MONTHS AFTER THE PRIMARY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED ALL ANATOMIC COMPONENTS (EXCEPT THE STEM) TO REVERSE COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11445733 ↗

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