GLOBAL ICONRecalls & reported problems across all models

We found 20 models of GLOBAL ICON by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 52 adverse event reports in the FDA's MAUDE database, received between Jun 28, 2018 and Jul 31, 2026 — classified as 46 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported GLOBAL ICON problems

GLOBAL ICON models

20 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GLOBAL ICON 1140-10-046

  Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
  6 reports
• GLOBAL ICON 1140-10-054

  Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
  6 reports
• GLOBAL ICON 1140-20-046

  Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
  6 reports
• GLOBAL ICON 1140-20-054

  Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
  5 reports
• GLOBAL ICON 1140-10-044

  Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
  4 reports
• GLOBAL ICON 1140-10-048

  Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
  4 reports
• GLOBAL ICON 1140-20-044

  Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
  3 reports
• GLOBAL ICON 1140-20-050

  Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
  3 reports
• GLOBAL ICON 1140-10-050

  Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
  2 reports
• GLOBAL ICON 1140-10-052

  Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
  2 reports
• GLOBAL ICON 1140-20-048

  Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
  2 reports
• GLOBAL ICON 1140-10-042

  Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
  1 report
• GLOBAL ICON 1140-20-052

  Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
  1 report
• GLOBAL ICON 2240-10-060

  Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
  1 report
• GLOBAL ICON 2240-13-052

  INSTRUMENT, CUTTING, ORTHOPEDIC
  1 report
• GLOBAL ICON 2240-11-042

  Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
  1 report
• GLOBAL ICON 1140-20-346

  Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
  1 report
• GLOBAL ICON 1140-20-348

  Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
  1 report
• GLOBAL ICON 1140-20-352

  Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
  1 report
• GLOBAL ICON 1140-20-354

  Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
  1 report

Recent GLOBAL ICON adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026Device-Device Incompatibility; Material Deformation

  It was reported that during a demonstration of the instruments it was observed that the icon Humeral punch bent and would not go through the icon Humeral prep guide. There was no surgical delay and no harm to the patient. All available information has been disclosed. No additional information could be provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50098108 ↗
• MalfunctionApr 6, 2026Incomplete or Missing Packaging; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT INTRAOPERATIVELY IN PRESENCE OF THE DPS SALES REP THE SHRINK-WRAPPED PRODUCT WAS OPENED. INSIDE BOTH STERILE PACKAGES WERE ALREADY OPENED AND THE IMPLANT WAS FOUND TO BE IN THE PACKAGE WITHOUT THE ELASTIC "SOCK". ANOTHER IMPLANT WAS USED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, NOR SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24789299 ↗
• InjurySep 4, 2024Use of Device Problem; Use of Device Problem

  REVISED TSR GLOBAL ICON AND APG+ DUE TO LOOSENING OF APG+ AND INSTABILITY. GLOBAL ICON WAS WELL FIXED BUT HAD AN APPROXIMATE 50 DEGREES OF RETROVERSION. THIS WAS REVISED TO A CEMENTED GLOBAL UNITE STEM. APG+ WAS LIFTING OFF THE BONE BOTH SUPERIOR AND INFERIOR BUT HAD GOOD FIXATION ON CENTRAL PEG. THIS WAS REVISED FOR THE SAME SIZE MATCHED APG+ IMPLANT BUT FULLY CEMENTED. PT HAD GOOD CUFF AND OPERATION WAS COMPLETED.

  Patient problems: Joint Laxity

  MAUDE report 20134206 ↗
• 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 ↗
• 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 ↗
• 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: (B)(6) 2019; DATE OF EVENT: (B)(6) 2023, (RIGHT SHOULDER). TREATMENT: REMOVAL OF OSTEOPHYTES AND SUBSCAPULARIS REPAIR.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 18857862 ↗
• 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 ↗
• 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 18118258 ↗
• MalfunctionAug 24, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL SHOULDER. DURING HUMERAL PREPARATION THE PIN BOUND IN THE PREP PLATE. NO TIME DELAY. NO HARM, ALL PARTS IDENTIFIED. PIN NOW PASSES THROUGH PLATE WITH DIFFICULTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17612719 ↗
• InjuryJun 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR FORAMINOTOMY SURGERY (NOT FOR THE STUDY SHOULDER) EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2019. DATE OF EVENT: (B)(6) 2020 (RIGHT SHOULDER).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14753025 ↗
• InjuryJun 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR FORAMINOTOMY SURGERY (NOT FOR THE STUDY SHOULDER) EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2019, DATE OF EVENT: (B)(6) 2020 (RIGHT SHOULDER).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14753022 ↗
• InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RAISED CRP LAB RESULT EVENT IS NOT SERIOUS AND IS CONSIDERED MILD EVENT IS POSSIBLY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018. DATE OF EVENT (ONSET): (B)(6) 2020. (LEFT SHOULDER) TREATMENT: NONE.

  Patient problems: Cardiac Arrest; Unspecified Infection

  MAUDE report 14713535 ↗
• InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RAISED CRP LAB RESULT. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018; DATE OF EVENT (ONSET): (B)(6) 2020; (LEFT SHOULDER). TREATMENT: NONE.

  Patient problems: Cardiac Arrest; Unspecified Infection

  MAUDE report 14713531 ↗
• InjuryFeb 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR AGGRAVATING NECK PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY EVENT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019; DATE OF EVENT (ONSET): (B)(6) 2019 (RIGHT SHOULDER). TREATMENT: UNSPECIFIED SURGICAL INTERVENTION NOT INVOLVING THE STUDY SHOULDER - NO PRODUCTS WERE REVISED.

  Patient problems: Pain

  MAUDE report 13414537 ↗
• InjuryFeb 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR AGGRAVATING NECK PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY EVENT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019; DATE OF EVENT (ONSET): (B)(6) 2019; (RIGHT SHOULDER). TREATMENT: UNSPECIFIED SURGICAL INTERVENTION NOT INVOLVING THE STUDY SHOULDER - NO PRODUCTS WERE REVISED.

  Patient problems: Pain

  MAUDE report 13414533 ↗

Other Depuy (Ireland) products

• ATTUNE1,475 models · 41,078 reports · 35 recalls
• QUICKSET66 models · 21,038 reports
• PINNACLE198 models · 7,240 reports
• DELTA XTEND194 models · 5,353 reports
• P.F.C. SIGMA487 models · 5,192 reports · 1 recall
• INHANCE202 models · 4,578 reports
• SMARTSET7 models · 4,415 reports
• SIGMA380 models · 3,831 reports