Anatomic Shoulder Prosthesis 04.01.0129Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630040713245), received between Oct 22, 2020 and Jan 23, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

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.

• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 8 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SUSPECTED DISLOCATION, BUT WITH ONLY INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE ANATOMICAL SHOULDER TO A REVERSE TOTAL SHOULDER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24162764 ↗
• InjuryApr 14, 2023Off-Label Use; Loosening of Implant Not Related to Bone-Ingrowth; Off-Label Use; Loosening of Implant Not Related to Bone-Ingrowth

  TOTAL ANATOMIC SHOULDER WAS IMPLANTED ON (B)(6) 2022. ANATOMIC HUMERAL HEAD (48MM) AND POLY GLENOID COMPONENT (42MM) WERE IMPLANTED, THIS COUPLING IS NOT ALLOWED AS PER MEDACTA ANATOMIC SHOULDER SURGICAL TECHNIQUE. AT 9 MONTHS FROM PRIMARY SURGERY THE PATIENT HAD PAIN AND SHOULDER INSTABILITY. THE SURGEON REVISED ALL COMPONENTS AND DURING REVISION IT WAS FOUND THAT THE GLENOID WAS MOBILIZED FROM BONE. REVERSE SHOULDER SYSTEM IMPLANTED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 16743206 ↗
• InjuryNov 8, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 1 YEAR 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A LOOSE GLENOID AND THE CAUSE IS UNKNOWN. THE SURGEON CONVERTED THE PATIENT FROM AN ANATOMIC SHOULDER TO REVERSE SHOULDER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 15750573 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN, 1 YEAR AND 3 MONTHS AFTER PRIMARY SURGERY, REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED ALL ANATOMIC COMPONENTS TO REVERSE COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 10718019 ↗

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