GLOBAL ADVANTAGE 1137-12-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295007142), received between Dec 19, 2017 and Feb 2, 2026 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHOULDER REVISION, REMOVAL OF GLOBAL ADVANTAGE TO ZIMMER COMPREHENSIVE. UNKNOWN IMPLANT DATE. REASON FOR REVISION IS ROTATOR CUFF ARTHROPATHY; ROTATOR CUFF NOT INTACT DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24232636 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR SHOULDER PAIN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 20182003 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO RULE OUT INFECTION. DOI: (B)(6) 2018. DOR: (B)(6) 2024. AFFECTED SIDE : LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 20086031 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED A ROTATOR CUFF TEAR. DOI: (B)(6) 2016. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18448503 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 17549813 ↗
• InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION RIGHT TOTAL SHOULDER REPLACEMENT. REVISION OF GLOBAL ADVANTAGE TOTAL SHOULDER REPLACEMENT. REMOVAL OF GLOBAL ADVANTAGE IMPLANTS INCLUDING ADVANTAGE STEM, ADVANTAGE HEAD, GLOBAL S-FIT METAL BACK GLENOID AND GLOBAL S-FIT POLY LINER. SURGEON THEN REVISED TO A DJO REVERSE TOTAL SHOULDER. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: NO, IP-01695932. DEVICE PROPERTY OF PATIENT, DEVICE IN POSSESSION OF DISCARDED, IP-01695933. DEVICE PROPERTY OF PATIENT, DEVICE IN POSSESSION OF NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: Pain

  MAUDE report 16868181 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD GLOBAL ADVANTAGE HEMI SHOULDER CONVERTED TO DELTA REVERSE DUE TO ROTATOR CUFF DEFICIENCY AND PAIN. THERE WERE NO ISSUES WITH EXPLANTED ITEMS AND NO NOTED PROBLEMS OR DELAYS. IMPLANTS ARE UNAVAILABLE FOR RETURN. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 16140402 ↗
• InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS LACK OF FUNCTION AND PAIN. NO SURGICAL DELAY. THE PATIENT HAD NO UPWARD MOBILITY WITH THEIR ARM. DOI: 10-11 YEARS AGO, DOR: (B)(6) 2021, LEFT SHOULDER.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 11286206 ↗
• MalfunctionApr 6, 2020Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem; Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem

  THE ¿PACKAGING¿ THAT SURROUNDED THE BOX AND THAT GUARANTEES THE STERILITY OF THE MATERIALS WAS DAMAGED AND, AS REPORTED BELOW, WAS ALERTED BY OUR TECHNICAL ASSISTANT, WHERE THE CORRECT CONDUCT OF THE HOSPITAL SHOULD HAVE BEEN TO REPROCESS THE MATERIAL BEFORE THE START OF SURGERY. THE BOX WITH THE DAMAGED ¿PACKAGING¿ REFERRED ONLY TO THE MAIN INSTRUMENTS THAT WOULD BE USED IN SURGERY; OTHER DISPOSABLE MATERIALS AND IMPLANTS WERE IN COMPLIANCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9930454 ↗
• InjuryAug 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN; DOR: (B)(6) 2019, RIGHT SHOULDER.

  Patient problems: No Code Available; Pain

  MAUDE report 8888910 ↗
• InjuryFeb 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND BROKE MID SHAFT HUMERUS; THE PATIENT HAD A PERIPROSTHETIC FRACTURE. THE INCIDENT INVOLVED THE LEFT SHOULDER. THE IMPLANT DATE IS UNKNOWN. THERE WAS A REVISION PROCEDURE ON (B)(6) 2019.

  Patient problems: Fall; Fracture, Arm; No Code Available

  MAUDE report 8317979 ↗
• InjuryDec 11, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 8150742 ↗
• InjuryNov 27, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM AND GLENOID DUE TO INFECTION. GLOBAL ADVANTAGE GLENOID, STEM AND HEAD WAS REMOVED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8107576 ↗
• InjuryNov 27, 2018Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF HUMERAL STEM AT BONE TO IMPLANT INTERFACE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8105420 ↗
• InjuryDec 19, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IMPLANT REMOVED DUE TO INFECTION. PATIENT CONSEQUENCE? :UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: Unspecified Infection

  MAUDE report 7130466 ↗