GLOBAL 1136-43-026Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10603295007012), received between Dec 19, 2017 and Mar 31, 2026 — classified as 1 death, 41 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (9 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 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Loss of or Failure to Bond; Naturally Worn

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR CONCERN FOR GLENOID COMPONENT LOOSENING/POLY WEAR RESULTING IN PAIN AND DYSFUNCTION IN RIGHT SHOULDER DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: PROBABLE, PROCEDURE RELATED: PROBABLE, DATE OF EVENT: 1 JAN 2026, DATE OF IMPLANT: ON (B)(6) 2013, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT SHOULDER. TREATMENT/IMPACT: ASPIRATION: YES. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 113643026, LOT NUMBER: 348444, COMPONENT TYPE: ANCHOR, DESCRIPTION: PREMIERON XLINKED GLENOID ANCHOR PEG 52MM, CATALOG NUMBER: 113014000, LOT NUMBER: 351106, COMPONENT TYPE: STEM, DESCRIPTION: GLOBAL HUMERAL STEM SZ 14, CATALOG NUMBER: 110052520, LOT NUMBER: FK1JD1, COMPONENT TYPE: HEAD, DESCRIPTION: GLOBAL UNITE HEAD 52X21 STD, CATALOG NUMBER: 113002000, LOT NUMBER: 371961, COMPONENT TYPE: TAPER ASSEMBLY, DESCRIPTION: GLOBAL AP TAPER ASSEMBLY 135 DEGREE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 24743483 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FAILED ROTATOR CUFF, RESULTING IN THE IMPLANTATION OF A REVERSE SHOULDER SYSTEM. DOI: (B)(6) 2015. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24210845 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S SHOULDER CONVERTED FROM A ATOMIC TO REVERSE DUE TO FAILURE OF THE ROTATOR CUFF. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23704815 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ROTATOR CUFF FAILURE LEADING TO CONVERSION OF ANATOMICAL SHOULDER TO REVERSE SHOULDER REPLACEMENT IN RIGHT ARM DOMINANT BUILDER. SURGEON SAYS THE PATIENT JUST WORE IT OUT FROM OVERUSE; HE ADVISED IT WAS NOT AN IMPLANT FAILURE. PATIENT EXPERIENCED PAIN AND INSTABILITY AS A RESULT OF THE EVENT.

  Patient problems: Joint Laxity; Pain; Unspecified Tissue Injury

  MAUDE report 23368992 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION AND ALL IMPLANTS WERE REMOVED AND NEW IMPLANTS WERE PUT IN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 23330304 ↗
• InjuryJul 7, 2025Loss of or Failure to Bond; Device Dislodged or Dislocated; Loss of or Failure to Bond; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAS A HISTORY OF MULTIPLE DISLOCATION WITH CLOSED REDUCTION. LAST CLOSED REDUCTION KNOCKED THE GLENOID COMPONENT LOOSE. THERE WAS GLENOID LOOSENING AT THE CEMENT/IMPLANT INTERFACE AND COMPETITOR CEMENT WAS USED. SURGEON REMOVED THE GLENOID COMPONENT AND 52 18 STD HEAD AND PUT IN 52 18 ECC HEAD WITH POSTERIOR ECCENTRICITY AS TENDENCY TO POP OUT ANTERIORLY. THE STEM WAS WELL FIXED. TREATED LIKE REAM AND RUN DID NOT THE REIMPLANT THE GLENOID. THIS OCCURRED ON THE LEFT SIDE. THERE WAS NO BROKEN IMPLANTS. THE PAST DISLOCATIONS WERE WHAT WAS REVISED IN THIS SURGERY. ALL PARTS OF THE HEAD AND GLENOID WERE REMOVED. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 22413140 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF ANATOMIC TO REVERSE TOTAL SHOULDER DUE TO ROTATOR CUFF FAILURE. STAFF WERE UNSURE OF THE IMPLANTATION DATE AND CANNOT READ THE LOT NUMBER OFF OF IMPLANT. THERE WAS NO IMPLANT FAILURE, NO LOOSENING, NO SURGEON COMPLAINTS, NO DELAY AND NO ADVERSE EVENT. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21993938 ↗
• InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ORIGINAL SURGERY WAS DONE IN 2013. DEPUY ADVANTAGE STEM, HUMERAL HEAD AND APG WERE REMOVED BECAUSE THE ROTATOR CUFF WAS TORN. DEPUY DELTA SHOULDER SYSTEM WAS IMPLANTED. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21583871 ↗
• InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN ANATOMIC IN AND WAS REVISED TO A REVERSE. ANATOMIC IMPLANTS WERE EXPLANTED. NO SURGICAL DELAY. NO PATIENT CONSEQUENCE. DOI: (B)(6) 2020, DOR: (B)(6) 2024, AFFECTED SIDE: UNKNOWN SHOULDER SIDE.

  Patient problems: Joint Laxity

  MAUDE report 21243614 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF TOTAL SHOULDER REPLACEMENT - CONVERTED TO REVERSE SHOULDER DUE TO ROTATOR CUFF FAILURE CAUSING PAIN AND REDUCED FUNCTION. RIGHT SHOULDER. ALL COMPONENTS EXPLANTED AND REPLACED WITH REVERSE SHOULDER. DOI: (B)(6) 2022; DOE: (B)(6) 2024.

  Patient problems: Loss of Range of Motion; Pain; Unspecified Tissue Injury

  MAUDE report 18857365 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A, ROTATOR CUFF TEAR. DOI: (B)(6) 2016. DOR: DEC 28, 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18448313 ↗
• InjurySep 8, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY? WHAT WAS THE DURATION OF THE DELAY? B. IT WAS INDICATED THAT THERE WAS GLENOID LOOSENING. ON WHAT INTERFACE DID THE LOOSENING OCCUR? C. WAS THERE ANY REVISION SURGERY PERFORMED BEFORE FOR THE MULTIPLE FALLS? D. WAS THERE AN ALLEGATION AGAINST THE STEM AND THE HUMERAL HEAD? A. NO SURGICAL DELAY. B. UNKNOWN. C. NO. D. NO ALLEGATION AGAINST STEM OR HEAD, SURGEON PREFERENCE TO REMOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17710603 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR PAIN. EXPLANTED THE PROXIMAL BODY OF THE GLOBAL UNITE STEM, THE GLOBAL HEAD AND ANCHOR PEG GLENOID. DOI: (B)(6) 2022. DOE: AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 17649986 ↗
• 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 17549810 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS TORN THEIR ROTATOR CUFF. WE CONVERTED TO A REVERSE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16993539 ↗
• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO THE SURGEON SUSPECTS INFECTION AND REMOVED COMPONENTS TO WAIT 6 WEEKS TO RETURN TO IMPLANT A REVERSE TOTAL SHOULDER. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 15084427 ↗
• InjuryJun 7, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO NO MOTION IN THE RIGHT SHOULDER. A SURGERY WAS PLANED TO REMOVE THE ADHESIONS AND IMPLANT A SMALLER HEAD. CULTURES WERE SENT TO RULE OUT INFECTION. RELEASES WERE PERFORMED AND ADHESIONS WERE REMOVED. RANGE OF MOTION WAS OBSERVED TO BE INCREASED FROM ZERO TO APPROXIMATELY 80 DEGREES. BUT, IT WAS ALSO DISCOVERED THAT THE GLENOID COMPONENT WAS LOOSE. THE DECISION WAS MADE TO CONVERT TO A HEMI SHOULDER ARTHROPLASTY AND GRAFT THE GLENOID. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 14625667 ↗
• InjuryMar 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HIS SHOULDER REPLACED BY SURGEON SOMETIME AGO .THE PATIENT HAD A GLOBAL UNITE CONSTRUCT IMPLANTED. THE PATIENT DID WELL INITIALLY BUT INJURED HIS ROTATOR CUFF AND LOST ROM OVER TIME. IT WAS DECIDED THAT SURGEON WOULD CONVERT THE ANATOMIC CONSTRUCT TO A REVERSE CONSTRUCT. THE APG , HUMERAL HEAD, AND PROXIMAL BODY WERE EXPLANTED DURING THE REVISION SURGERY. THE STEM WAS LEFT IN SITU AND A DELTA REVERSE CONSTRUCT WAS IMPLANTED. THE ORIGINAL IMPLANT DATE IS UNKNOWN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Loss of Range of Motion; Unspecified Musculoskeletal problem

  MAUDE report 13667216 ↗
• InjuryDec 20, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENTS GLENOID BECAME LOOSE. REMOVED THE LOOSE GLENOID AND HUMERAL HEAD. SURGEON WANTED TO CONVERT THE SHOULDER TO A HEMI. SURGEON TRIALED A 56X21 AND FOUND IT TO BE STABLE. THE REAL HUMERAL HEAD WAS OPENED AND IMPLANTED. CLOSING PROCESS BEGAN AND SURGEON WAS UNSURE OF WHERE AND WHEN THE PATIENTS INITIAL SURGERY WAS PERFORMED. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2021. RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 13045531 ↗
• DeathNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). THE CASE IS STILL ONGOING, OUR ASSESSMENT THEREFORE PRELIMINARY: SERIOUSNESS: YES, CAUSALITY TO MEDICAL DEVICE: NO, CAUSALITY TO STUDY PROCEDURE: YES (POSSIBLE), EXPECTEDNESS: YES, INFLUENCE ON RISK/BENEFIT RATIO: NO, PROPOSED MEASURES FOR PATIENT SAFETY: NONE. OUR NARRATIVE AT THE MOMENT: A (B)(6) MALE PARTICIPANT OF THE (B)(6) STUDY WHO HAD UNDERGONE SURGICAL IMPLANTATION OF GLOBAL ICON SHOULDER PROSTHESIS ON (B)(6) 2021 AS PER STUDY PROTOCOL EXPERIENCED A BILATERAL FULMINANT PULMONARY EMBOLISM THAT LED TO A CARDIOVASCULAR STANDSTILL ON (B)(6) 2021 4:20 P.M. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE MEDICAL DEVICE BUT POSSIBLY TO THE STUDY PROCEDURE (SURGICAL IMPLANTATION). THE PATIENT HAS CURRENTLY REGAINED HIS OWN RHYTHM BUT IS STILL ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THE EVENT IS STILL ONGOING. SITE AWARENESS DATE: 18-10-2021. DATE OF SURGERY : (B)(6) 2021.

  Patient problems: Heart Failure/Congestive Heart Failure; Pulmonary Embolism

  MAUDE report 12811579 ↗
• InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR PAROXYSMAL ATRIAL FIBRILLATION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY THE EVENT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018, DATE OF EVENT (ONSET): (B)(6) 2019, (LEFT SHOULDER). TREATMENT: HOSPITALIZATION WITH MEDICAL INTERVENTION (UNSPECIFIED).

  Patient problems: Arrhythmia

  MAUDE report 12631394 ↗
• InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR PNEUMONIA. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY THE EVENT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018, DATE OF EVENT (ONSET): (B)(6) 2019, (LEFT SHOULDER). TREATMENT: HOSPITALIZATION WITH MEDICAL INTERVENTION (UNSPECIFIED).

  Patient problems: Pneumonia

  MAUDE report 12631351 ↗
• InjuryJun 25, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION RECEIVED. UPDATED EVENT DESCRIPTION: CLINICAL ADVERSE EVENT RECEIVED FOR PAIN IN RIGHT BICEPS TENDON. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2018, DATE OF EVENT: 24 MAR 2021 (RIGHT SHOULDER). TREATMENT: MARCAINISATION.

  Patient problems: Pain

  MAUDE report 12066949 ↗
• InjuryMar 1, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT HAD A CONVERSION OF PRIMARY ARTHROPLASTY TO REVERSE CONSTRUCT DUE TO MALPOSITIONING OF THE GLENOID. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 11392037 ↗
• InjuryFeb 12, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS PAIN, INSTABILITY AND LOOSENING OF THE GLENOID COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2018, DOR: (B)(6) 2021, LEFT SHOULDER.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11321985 ↗