Anatomic Shoulder Prosthesis 04.01.0024Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630040712620), received between Jul 29, 2022 and Apr 23, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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.

• InjuryApr 23, 2026Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE ANATOMICAL SHOULDER TO A REVERSE SHOULDER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24964780 ↗
• InjuryFeb 16, 2026Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON REMOVED THE IMPLANTS AND PLACED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24343897 ↗
• InjuryDec 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND POOR RANGE OF MOTION WAS OBSERVED. THE SURGEON AT ABOUT 3 YEARS AND 4 MONTHS POST PRIMARY DECIDED TO REMOVE ALL COMPONENTS EXCEPT THE STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 16032690 ↗
• InjuryJul 29, 2022Loose or Intermittent Connection; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD PRIMARY SURGERY OF MEDACTA PRODUCTS ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE HUMERAL COMPONENT AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE DIAPHYSIS, METAPHYSIS, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE COMPETITOR GLENOSPHERE AND STEM LOOSENING. THE SURGEON REMOVED THE REVERSE LINER, METAPHYSIS AND STEM AND IMPLANTED AN ANATOMIC METAPHYSIS, DOUBLE ECCENTER AND HUMERAL HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD A PREVIOUS REVISION SURGERY OF COMPETITOR'S PRODUCTS: REVERSE 6+ YEARS POST PRIMARY THAT WAS MISSING A LARGE PORTION OF THE PROXIMAL HUMERUS. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO SUSTAINING A WOUND BREAKDOWN FROM THE PREVIOUS REVISION SURGERY. THE SURGEON REMOVED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 15127596 ↗

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