GLOBAL 1136-40-026Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10603295006954), received between Dec 11, 2017 and Jan 20, 2026 — classified as 34 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (6 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 35 reports, in the reporter's own words as published by the FDA.

• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL SURGERY ON (B)(6) 2019. OJPT TIME THE ROTATOR CUFF BECOME DEFICIENCY. ON (B)(6) 2026 THE IMPLANT TO A REVERSE TOTAL SHOULDER WITHOUT INCIDENT. DOI- (B)(6) 2019. DOR- (B)(6) 2026. AFFECTED SIDE - LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24119513 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT TORE ROTATOR CUFF AND NEEDED TO BE CONVERTED TO A REVERSE - ANOTHER SYSTEM WAS USED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24010597 ↗
• InjuryNov 26, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE SHOULDER FAILED. IT WAS LOOSE APG AND STEM. THERE WAS NO INFECTION AND NO HARM TO PATIENT. THERE WAS NO DELAYS. IT WAS CONVERTED TO A REVERSE. THERE WAS NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 23657695 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ANATOMIC SHOULDER WAS REVISED TO REVERSE DUE TO CUFF TEAR. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23407375 ↗
• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A TSA. SUBSCAP FAILED AND WAS CONVERTED TO AN RSA. DOI: (B)(6) 2017. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22358615 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CONVERSION OF AN ANATOMIC SHOULDER WAS REQUIRED DUE TO ROTATOR CUFF LIGAMENTS BEING WORN. THERE WAS NO SURGICAL DELAY. AFFECTED AREA: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21976259 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISES DUE TO THE FAILURE OF THE ROTATOR CUFF. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21854739 ↗
• InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL SHOULDER REPLACEMENT ON (B)(6) 2024. THE PATIENT DISRUPTED / TORE ROTATOR CUFF BUT DID NOT PRESENT TO SURGEON UNTIL ONE YEAR LATER. THE HUMERUS WAS COMPLETELY SCARRED IN AND IN A FIXED ANTERIOR POSITION. DOCTOR FELT REVISION TO REVERSE WOULD BE UNSTABLE. CHOSE TO CONVERT TO A 145 EPI AND A 48X26MM CTA HEAD. DOI- UNKNOWN. DOR (B)(6) 2024. AFFECTED SIDE- LEFT SHOULDER.

  Patient problems: Adhesion(s); Unspecified Tissue Injury

  MAUDE report 20610387 ↗
• InjuryAug 28, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  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 20084685 ↗
• InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO RUPTURED SUBSCAP. PATIENT HAD HER ANATOMIC TOTAL SHOULDER CONVERTED TO A REVERSE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18986434 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A CUFF TEAR. SURGEON CONVERTED FROM A TSA TO A REVERSE SHOULDER. SURGICAL DELAY UNKNOWN. ACTIVITY LEVEL - YES. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18442533 ↗
• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH ANATOMIC UNITE SHOULDER CONVERSION TO DELTA XTEND DUE TO SUBSCAPULARIS INJURY. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17958339 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ANATOMIC SHOULDER REPLACEMENT AT BOWEN HOSPITAL WELLINGTON IN (B)(6) 2022, UNSURE OF THE DATES. SHE PRESENTED WITH ROTATOR CUFF FAILURE AND REQUIRED CONVERSION FROM GLOBAL UNITE ANATOMIC TO DELTA XTEND REVERSE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16642955 ↗
• 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 14713521 ↗
• InjuryApr 14, 2022Adverse 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) 2022, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 14112410 ↗
• InjuryAug 5, 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

  CLINICAL ADVERSE EVENT RECEIVED FOR BICEPS TENDONITIS AFTER TENODESIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): 06/08/2020, (RIGHT SHOULDER). TREATMENT: MEDICAL INTERVENTION/MODIFICATION (DETAILS UNSPECIFIED).

  Patient problems: Inflammation; Muscle/Tendon Damage

  MAUDE report 12283053 ↗
• InjuryJul 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2020. DOR: (B)(6) 2021; RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 12135962 ↗
• InjuryApr 5, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE HEAD AND GLENOID WAS EXPLANTED FOR LOOSENING. HEAD EXCHANGED IN PROCESS. LOOSENING OF INTERFACE BONE/CEMENT. DOI: (B)(6) 2017 DOR: (B)(6) 2019 RIGHT SHOULDER.

  Patient problems: Osteolysis

  MAUDE report 11613868 ↗
• InjuryJul 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL SHOULDER. SURGEON EXPLANTED PROXIMAL UNITE BODY AND APG GLENOID, REVISING TO REVERSE. DOI: (B)(6) 2019 DOR: (B)(6) 2020 RIGHT SHOULDER.

  Patient problems: No Code Available; Pain

  MAUDE report 10289978 ↗
• InjuryJul 9, 2020Loss of or Failure to Bond; Device Dislodged or Dislocated; Loss of or Failure to Bond; Device Dislodged or Dislocated

  ANATOMIC TOTAL SHOULDER REPLACEMENT, (B)(6), (B)(6) 2020; PRIMARY IMPLANT DATE: (B)(6) 2019; REASON FOR REVISION: FAILURE OF FIXATION OF THE ANCHOR PEG GLENOID COMPONENT OF A GLOBAL ICON ANCHOR PEG GLENOID ATSR (B)(6) 2020. CT IMAGE AND X-RAY IMAGES AVAILABLE. BEING REVISED TO DELTA XTEND RTSR. PATIENT ACTIVITY LEVELS; SEMI SEDENTARY.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10251645 ↗
• InjuryApr 13, 2020Fracture; Fracture

  THE PATIENT HAD A REVISION SHOULDER FOR MALFUNCTIONING GLENOID COMPONENT. SIZE 40 GLENOID ANCHOR PEG SHEARED OFF AT BONE. GLENOID COMPONENT BECAME LOOSE WITH ANCHOR PEG STILL INTACT IN THE GLENOID BONE. PARTS WERE REMOVED & REVISION WAS PERFORMED. NO INFRA OP INCIDENTS OCCURRED DURING SURGERY. THERE WERE NO DELAYS IN SURGERY. THE SURGEON DECIDED INTRA OP TO USE A COMPETITIVE UNIVERSAL BASE PLATE. HE UNDERSTOOD THE IMPLICATIONS OF OFF LABEL USAGE.

  Patient problems: No Code Available

  MAUDE report 9953594 ↗
• 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 9930397 ↗
• InjuryJan 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS LOST FUNCTION OF SUBSCAP AND WAS CONVERTED TO A REVERSE SHOULDER FROM ANOTHER COMPANY. COULD NOT GET A COMPLETE SET OF RECORDS. PATIENT HAD TOTAL SHOULDER DONE IN 2010. DOI: (B)(6) 2010; DOR: (B)(6) 2019; RIGHT SHOULDER.

  Patient problems: No Code Available

  MAUDE report 9577419 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PERSISTENT PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2019 (LEFT SHOULDER).

  Patient problems: No Code Available; Pain

  MAUDE report 9520905 ↗
• InjuryNov 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR BURSITIS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019; DATE OF EVENT (ONSET): (B)(6) 2019; (RIGHT SHOULDER).

  Patient problems: No Code Available

  MAUDE report 9287766 ↗