GLOBAL ICON 1140-10-046Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295381112), received between Oct 17, 2019 and Jun 12, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Use of Device 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2024Use of Device Problem; Use of Device Problem

  STUDY NO: DOTS. CLINICAL NOTIFICATION RECEIVED, FOR REVISION, DUE TO MALPOSITION/NON-UNION. DATE OF IMPLANT: (B)(6) 2024; DATE OF REVISION: (B)(6) 2024 (LEFT SHOULDER). TREATMENT: STEM, GLENOID, CUP, METAGLENE AND HEAD WERE REVISED.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 19525448 ↗
• InjuryJul 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ROTATOR CUFF RUPTURE IN PATIENT WITH RA EVENT IS SERIOUS AND IS CONSIDERED MODERATE EVENT IS PROBABLY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2019, (RIGHT SHOULDER). TREATMENT: REVISION TO REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10224420 ↗
• InjuryMar 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN AND STIFFNESS LEFT SHOULDER. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019; DATE OF EVENT (ONSET): (B)(6) 2020; (LEFT SHOULDER). TREATMENT: MEDICAL INTERVENTION/MODIFICATION (UNSPECIFIED): YES. DIAGNOSTIC INTERVENTION (UNSPECIFIED): YES. PHYSICAL THERAPY: YES.

  Patient problems: No Code Available; Pain

  MAUDE report 9788492 ↗
• InjuryJan 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DORSAL SUBLUXATION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019; DATE OF EVENT (ONSET): (B)(6) 2020; (RIGHT SHOULDER). TREATMENT: DIAGNOSTIC INTERVENTION (UNSPECIFIED) ONLY.

  Patient problems: No Code Available; Pain

  MAUDE report 9623644 ↗
• InjuryOct 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PERSISTENT PAIN AFTER AC RESECTION AND PROBABLE RUPTURE SUBSCAPULARIS EVENT IS NOT SERIOUS EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019; DATE OF EVENT (ONSET OR WORSENING): (B)(6) 2019; (RIGHT SHOULDER).

  Patient problems: No Code Available; Pain

  MAUDE report 9214346 ↗
• InjuryOct 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CLINICAL DATABASE DOCUMENTED THAT THE ASPIRATION OF THE LEFT SHOULDER TO ADDRESS PAIN IS NOT RELATED TO DEPUY PRODUCTS OR PROCEDURES.

  Patient problems: No Code Available; Pain

  MAUDE report 9202149 ↗