GLOBAL 1136-43-025Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295007005), received between Jul 7, 2020 and Jul 7, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT PRESENT IN THE DOCTOR'S OFFICE WITH A PAINFUL LEFT SHOULDER AND A DECREASE IN RANGE OF MOTION. SURGEON ORDERED A SERIES OF STUDIES AND FORMED THE OPINION THAT THE INDEX GLENOID COMPONENT WAS LOOSE. THE SURGEON REVISED THE SHOULDER. UPON EXPOSURE TO THE JOINT SPACE, DR. REMOVED THE 52X18 STANDARD HUMERAL HEAD FOR THE AP SHOULD SYSTEM, AND THE 135 TAPERED SPACER WITH THE STANDARD HEAD REMOVAL FORK IN THE GLOBAL AP TRAYS. THE SIZE 10 GLOBAL AP STANDARD STEM WAS KEPT IMPLANTED. SURGEON THEN EASILY REMOVED THE 52 ANCHOR PEG GLENOID WITH A PAIR OF KOCHERS. DUE TO BONE LOSS, SURGEON THEN IMPLANTED A COMPETITIVE GLENOID. NO INSTRUMENTATION BROKE DURING SURGERY AND THERE WERE NO DELAYS.

  Patient problems: Injury; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 10240911 ↗