Anatomic Shoulder Prosthesis 04.01.0131Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630040713269), received between Sep 4, 2019 and Jun 12, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Unstable” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2020Unstable

  THE SURGEON REVISED THE ANATOMICAL SHOULDER TO A REVERSE SYSTEM 9 MONTHS AFTER THE PRIMARY SURGERY. THE PATIENT CAME IN ((B)(6) 2020) WITH INSTABILITY AND PAIN, THE PEGGED GLENOID WAS MOBILIZED ALSO. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019, AT 5 MONTHS FOLLOW-UP VISIT THE PATIENT WAS FINE. THE SUBSCAPULARIS OSTEOTOMY PERFORMED IN ANATOMICAL REPLACEMENT HAD PROBABLY DISPLACED AND NEVER HEALED, LEADING TO ECCENTRIC LOADS, INSTABILITY AND EVENTUALLY DISSOCIATION OF THE HC PEGGED GLENOID FROM THE BONE.

  Patient problems: Joint Disorder

  MAUDE report 10148614 ↗
• InjurySep 4, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN, 2 MONTHS AFTER PRIMARY SURGERY, COMPLAINING OF PAIN DUE TO A TORN SUBSCAPULARIS MUSCLE. THE CAUSE OF THE TEAR IS UNKNOWN. THE SURGEON REMOVED THE HC PEGGED GLENOID, METAL HUMERAL HEAD, DOUBLE ECCENTER AND HUMERAL ANATOMICAL METAPHYSIS-CEMENTLESS AND IMPLANTED REVERSE SYSTEM IMPLANTS SUCCESSFULLY.

  Patient problems: No Code Available; Pain

  MAUDE report 8959608 ↗

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