Anatomic Shoulder Prosthesis 04.01.0089Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630040713122), received between Feb 10, 2021 and Jan 8, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• InjuryJan 8, 2026Device Appears to Trigger Rejection

  AT ABOUT 3 WEEKS FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE DOUBLE ECCENTER AND HUMERAL HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24004371 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Separation Problem; Adverse Event Without Identified Device or Use Problem; Separation Problem

  ABOUT TWO WEEKS AFTER THE PREVIOUS REVISION SURGERY, THE HUMERAL HEAD WAS FOUND DETACHED FROM THE DOUBLE ECCENTRIC. THE SURGEON REVISED THE HUMERAL HEAD AND THE DOUBLE ECCENTRIC AND TRIMMED THE SURROUNDING BONE BY USING A RONGEUR. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT HISTORY: PRIMARY SURGERY PERFORMED ON (B)(6) 2025. FIRST REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO JOINT LUXATION; LINER AND GLENOSPHERE REVISED. SECOND REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO JOINT LUXATION; LINER AND GLENOSPHERE REVISED. THIRD REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO JOINT LUXATION; LINER, GLENOSPHERE, AND METAPHYSIS REVISED. FOURTH REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE JOINT LUXATION; PATIENT CONVERTED TO HEMIARTHROPLASTY - GLENOSPHERE AND BASEPLATE REMOVED, LINER AND METAPHYSIS REPLACED WITH ANATOMICAL COMPONENTS. THIS IS THE FIFTH REVISION SURGERY PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 22585412 ↗
• InjuryFeb 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PATIENT CAME IN REPORTING PAIN DUE TO THE HUMERAL HEAD DISSOCIATING FROM THE DOUBLE ECCENTER 2 WEEKS AFTER THE PRIMARY. THE SURGEON TOOK THE HEAD OUT, CLEANED UP THE AREA AND WAS ABLE TO PUT THE ORIGINAL HEAD BACK ON. THE SURGEON DID NOT USE ANY NEW IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 11306024 ↗

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