GLOBAL ADVANTAGE 1137-10-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295007111), received between Dec 20, 2017 and Jan 31, 2025 — classified as 16 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJan 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: NO SURGICAL DELAY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21285914 ↗
• InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION GLOBAL ADVANTAGE HEMI ARTHROPLASTY. PATIENT PRESENTED TO SURGEON WITH PAIN. GLOBAL ADVANTAGE STEM AND HEAD REMOVED AND REVISION TO DJO REVERSE TOTAL SHOULDER ARTHROPLASTY PERFORMED. DOI: (B)(6) 2004; DOE: (B)(6) 2024;

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 19106266 ↗
• InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATENT WAS REVISED AFTER STROKE AND ROTATOR CUFF RUPTURE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18084995 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO HEMI SHOULDER ARTHROPLASTY PAIN. IT WAS REVISED TO A TOTAL REVERSE ARTHROPLASTY AND THERE WERE NO SIGNS OF INFECTION. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Pain

  MAUDE report 17440035 ↗
• InjuryMay 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR CONVERSION FROM HEMI TO TOTAL DUE TO GLENOID CYST. DOR: (B)(6) 2023.AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Cyst(s)

  MAUDE report 16954270 ↗
• InjuryMar 3, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION OF ANATOMIC SHOULDER TO REVERSE SHOULDER - ASEPTIC LOOSENING OF ANATOMIC SHOULDER COMPONENTS, IMPLANTS REMOVED AND REVERSE UNABLE TO BE COMPLETED, THEREFORE, REVERSE STEM WITH CTA HEAD WAS IMPLANTED. THE HEAD WAS REMOVED WITH THE REMOVAL TOOL, THEN BOTH THE STEM AND THE GLENOID WERE ABLE TO BE REMOVED WITH LITTLE TO NO EFFORT - WERE MORE JUST SITTING IN THE HUMERAL CANAL AND GLENOID BONE RATHER THAN ATTACHED TO THESE INTERFACES.

  Patient problems: Insufficient Information

  MAUDE report 11405243 ↗
• InjuryDec 8, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED STATING THAT IT WAS CONFIRMED THAT THERE HAS ONLY BEEN 1 REVISION PROCEDURE ON (B)(6) 2020. THE REASON WAS FOR INFECTION AND ROTATOR CUFF FAILURE. LOOSENING OF THE STEM WAS NOTED DURING EXTRACTION, BUT THE REASON FOR IT WAS NOT GIVEN BUY THE SURGEON. A CEMENT SPACER WAS IMPLANTED DURING THIS PROCEDURE AND A SECOND PROCEDURE IS PLANNED WHERE A COMPETITOR SYSTEM (REVERSE SHOULDER) WILL BE IMPLANTED.

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

  MAUDE report 10967863 ↗
• InjuryJan 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2020; LEFT SHOULDER.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9633567 ↗
• InjuryJan 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION AND PAIN. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT SHOULDER.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 9633429 ↗
• InjuryApr 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAINFUL HEMI WITH POTENTIAL CUFF DEFICIT. DOI: UNK DOR: (B)(6) 2019 LEFT SHOULDER.

  Patient problems: No Code Available; Pain

  MAUDE report 8482097 ↗
• InjuryJan 2, 2019Separation Problem; Separation Problem

  PATIENT REVISED DUE TO DISASSOCIATION OF IMPLANTS.

  Patient problems: No Code Available

  MAUDE report 8208805 ↗
• InjuryOct 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN, DISCOMFORT, AND TIGHTNESS IN SHOULDER.

  Patient problems: Discomfort; Loss of Range of Motion; No Code Available; Pain

  MAUDE report 7973124 ↗
• InjurySep 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNK; DOR: (B)(6) 2018; RIGHT SHOULDER.

  Patient problems: Not Applicable; Pain

  MAUDE report 7865618 ↗
• InjurySep 5, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE GLENOID AND HUMERAL STEM AT THE CEMENT TO IMPLANT INTERFACE POST REVISION SURGERY DONE APPROXIMATELY 10 YEARS AGO IN (B)(6). CEMENT MANUFACTURER IS UNKNOWN. FAILED TSA DUE TO PATIENT FALLING AND TRYING TO SLOW HIS FALL BY GRASPING FOR SUPPORT. ALL COMPONENTS REMOVED AND REPLACED. DOI: 10 YEARS AGO DOR: (B)(6) 2018 UNK SHOULDER.

  Patient problems: Fall

  MAUDE report 7845523 ↗
• InjuryJun 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS SHOULDER PAIN. DEFICIENT ROTATOR CUFF AND A CONVERSION FROM ANATOMIC TO REVERSE. DOI: (B)(6) 2016; DOR: (B)(6) 2018; RIGHT SHOULDER.

  Patient problems: Pain

  MAUDE report 7631039 ↗
• 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 7133625 ↗