Anatomic Shoulder Prosthesis 04.01.0003Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630040706025), received between Mar 7, 2019 and Dec 9, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryDec 9, 2025Device Dislodged or Dislocated; Osseointegration Problem; Device Dislodged or Dislocated; Osseointegration Problem

  REVISION SURGERY DUE TO JOINT SUBLUXATION AT ABOUT 5 YEARS 10 MONTHS FROM PRIMARY. NO PAIN REPORTED. IT WAS THEREFORE DECIDED TO PERFORM SURGERY TO INCREASE THE HEIGHT OF THE INLAY IN ORDER TO RESTORE SUFFICIENT STABILITY. DURING THE REVISION SURGERY IT WAS FOUND THAT THE STEM WAS ALSO LOOSE. THE SURGEON DECIDED TO REVISE THE STEM (SAME SIZE, CEMENTLESS TO CEMENTED), METAPHYSIS (+0 TO +9 MM) AND LINER (+3MM TO +6 MM E-CROSS CONSTRAINED) AT 155 DEGREES. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration; Joint Dislocation

  MAUDE report 23758551 ↗
• InjuryAug 5, 2022Positioning Problem

  REVISION SURGERY PERFORMED 4 YEARS AFTER THE PRIMARY SURGERY DUE TO GLENOSPHERE POSITION TOO SUPERIOR (IMPINGEMENT) AND STEM WAS NOT STABLE. ALL IMPLANTS REVISED. THE PATIENT ALREADY HAD PREVIOUS REVISION SURGERY DUE TO INFECTION.

  Patient problems: Failure of Implant

  MAUDE report 15174131 ↗
• InjuryMar 7, 2019Device Slipped

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY PROBABLY BECAUSE OF LOOSE SOFT TISSUE TENSION 2 WEEKS AFTER A FIRST REVISION OF DJO PRODUCTS WITH MEDACTA HUMERUS DEVICES. THE SURGEON REVISED THE MEDACTA LINER, METAPHYSIS AND DIAPHYSIS AND THE SURGERY WAS COMPLETED SUCCESSFULLY. INITIAL SURGERY WAS A PRIMARY REVERSE WITH DJO. THE PATIENT'S DJO PROSTHESIS BASEPLATE CENTRAL SCREW BROKE. THE PATIENT HAS BEEN REVISED TO (2ND SURGERY) MEDACTA HUMERUS AND TORNIER BASEPLATE AND GLENOSPHERE. THIRD PROCEDURE (THIS CASE IN QUESTION) THE BASEPLATE AND GLENOSPHERE IN WERE TORNIER, THEN WAS REVISED TO TORNIER. MEDACTA HUMERUS WAS REMOVED AND PLACED IN A MORE RETROVERTED POSITION AND UPSIZED WITH ALL NEW COMPONENTS.

  Patient problems: Joint Disorder

  MAUDE report 8399585 ↗

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