GLOBAL 1137-85-025Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295007241), received between Dec 20, 2017 and Apr 4, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THERE WAS REVISION TSR TO RSR DUE TO CUFF FAILURE AND GLENOID LOOSENING. THE PATIENT HAS HAD A LONG-TERM GOOD RESULT FROM HER ANATOMIC TOTAL SHOULDER REPLACEMENTS. IN THE LAST COUPLE OF YEARS, THE RIGHT SIDE HAS BECOME PAINFUL, AND IT APPEARS THAT HER ROTATOR CUFF HAS GIVEN WAY, AS SUGGESTED BY THE SUPERIOR MIGRATION OF THE HUMERAL COMPONENT.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 21772290 ↗
• InjuryFeb 18, 2022Loss of or Failure to Bond; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO GLENOID IMPLANT FAILURE LEADING TO ROTATOR CUFF FAILURE. RIGHT SHOULDER. INITIAL SURGERY DATE: APPROX 16 YEARS AGO. EXACT DATE UNKNOWN AS NO NOTES AVAILABLE. REVISION OF RIGHT ANATOMIC SHOULDER REPLACEMENT. DOI: APPROX. 16 YEARS AGO, DOR: (B)(6) 2022, RIGHT SHOULDER.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 13559079 ↗
• InjuryNov 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 12869281 ↗
• InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SHOULDER ARTHROPLASTY. REMOVAL OF GLOBAL AP TSR, REVISING TO COMPETITOR REVERSE SHOULDER ARTHROPLASTY. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM JNJ SALES REPRESENTATIVE: SURGEON QUERIED INFECTION AT IMPLANT SITE, AS A REASON FOR POST OP PAIN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 10900824 ↗
• InjuryJul 23, 2018Osseointegration Problem; Osseointegration Problem

  REVISION TOTAL SHOULDER REPLACEMENT, DR (B)(6), (B)(6) HOSPITAL ON (B)(6) 2018. PRIMARY TOTAL SHOULDER REPLACEMENT WAS CARRIED OUT BY DR. (B)(6) ON THE (B)(6) 2007. THE PATIENT COMPLAINED OF A PAINFUL SHOULDER. THE SURGEON HAD XRAYS CARRIED OUT ON THE SHOULDER AND IT WAS NOTED THAT THERE WAS SUBSTANTIAL OSTEOLYSIS OF THE GLENOID MEDIAL TO THE PROSTHESIS. A REVISION TOTAL SHOULDER REPLACEMENT WAS CARRIED OUT BY THE SURGEON ON THE (B)(6) 2018. THE SURGEON REMOVED THE HUMERAL HEAD AND THE GLENOID PROSTHESIS. DURING EXPOSURE OF THE GLENOID THE SURGEON NOTED THAT THE GLENOID PROSTHESIS WAS LOOSE AND COULD BE REMOVED WITHOUT THE AID OF INSTRUMENTS. AN ANATOMIC TSR REVISION WAS CARRIED OUT AS THE ROTATOR CUFF WAS STILL INTACT, THE PATIENTS AGE AND THE FACT THAT THE PATIENT HAD A PLATE ON THE HUMERUS. THE GLENOID VAULT WAS BONE GRAFTED USING FEMORAL ALLOGRAFT, AN ANCHOR PEG GLENOID WAS IMPLANTED AND A GLOBAL ADVANTAGE HUMERAL HEAD WAS ATTACHED TO THE STEM. FEMALE PATIENT. (B)(6).

  Patient problems: Inadequate Osseointegration; Osteolysis; Pain

  MAUDE report 7709741 ↗
• InjuryDec 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  ALL COMPONENTS WERE REMOVED. THE PATIENT HAD PAIN, REDUCED RANGE OF MOTION AND SEVERE WEAR OF THE GLENOID BONE. A CEMENT SPACER WAS INSERTED AND WILL BE REVISED AT A LATER STAGE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 7133644 ↗