Anatomic Shoulder Prosthesis 04.01.0093Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630040713160), received between Jul 1, 2021 and Oct 4, 2023 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT 1 YEAR AND 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO NOT BEING ABLE TO HAVE FULL ARM ROTATION. RANGE OF MOTION WAS LIMITED AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 17868939 ↗
• InjuryApr 12, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 3 YEARS 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A TORN ROTATOR CUFF AND THE CAUSE IS UNKNOWN. THE SURGEON CONVERTED THE PATIENT FROM ANATOMIC TO REVERSE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 16723117 ↗
• InjuryOct 20, 2021Appropriate Device Problem Term/Code Not Available

  AT 6 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND LACK OF RANGE OF MOTION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE GLENOID, HEAD, DOUBLE ECCENTER, AND PROXIMAL BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 12663709 ↗
• InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem

  1 YEAR AND 5 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN DUE TO A FAILED SUBSCAPULARIS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HUMERAL HEAD, HUMERAL ANATOMIC METAPHYSIS, DOUBLE ECCENTER, AND HC PEGGED GLENOID. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 12098250 ↗

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