GLOBAL ICON 1140-10-048Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295381129), received between Jan 29, 2020 and Mar 7, 2024 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR REMOVAL OF OSTEOPHYTES AND SUBSCAPULARIS REPAIR. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: ON (B)(6) 2019, DATE OF EVENT: UNK JUL 2023, (RIGHT SHOULDER). TREATMENT: REMOVAL OF OSTEOPHYTES AND SUBSCAPULARIS REPAIR.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 18857875 ↗
• MalfunctionNov 13, 2023No Apparent Adverse Event; No Apparent Adverse Event

  CLINICAL ADVERSE EVENT RECEIVED FOR GLENOID FRACTURE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2018. DATE OF EVENT: (B)(6) 2020. (RIGHT SHOULDER) TREATMENT: NONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18118259 ↗
• InjuryDec 14, 2020Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  REVISION OF A GLOBAL ICON DUE TO PAIN. ALL DEPUY SYNTHES PRODUCTS WERE REMOVED. WHEN THE COMPONENTS WERE REMOVED IT LOOKED LIKE THE PATIENT MAY HAVE HAD AN INFECTION. TISSUE SAMPLES WERE TAKEN. PRIMARY SURGERY WAS DONE ON (B)(6) 2018. COMPETITOR PRODUCTS WERE THEN IMPLANTED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN. WERE FRAGMENTS GENERATED? UNKNOWN. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: UNKNOWN. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. OTHER INFORMATION: LEFT SIDE. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4). DEVICE PROPERTY OF: NONE. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 11003886 ↗
• InjuryJan 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR BURSITIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS PROBABLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018; DATE OF EVENT (ONSET): (B)(6) 2020; (RIGHT SHOULDER).

  Patient problems: No Code Available

  MAUDE report 9641657 ↗