Anatomical Shoulder™ Domelock® 01.04212.505Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024485297), received between Feb 3, 2021 and May 30, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 30, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Extraskeletal ossification; Loss of Range of Motion; Osteolysis; Pain; Radiolucent Lines

  MAUDE report 17018238 ↗
• InjuryNov 18, 2021Device Dislodged or Dislocated; Material Integrity Problem; Device Dislodged or Dislocated; Material Integrity Problem

  IT WAS REPORTED THAT, HEAD BECAME DISASSOCIATED FROM THE STEM. PATIENT OUTCOME- REVISION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12834684 ↗
• InjuryFeb 3, 2021Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS IMPLANTED ON RIGHT SIDE AND SUFFERED FROM A COMPLETE RUPTURE OF THE SUBSCAPULAR TENDON MEASURING MORE THAN 2 CM. THE PATIENT WAS INITIALLY HANDLED CONSERVATIVELY (NO INTERVENTION), BUT EVENTUALLY REVISION TOOK PLACE.

  Patient problems: Muscle/Tendon Damage; Rupture

  MAUDE report 11271128 ↗