GLOBAL 1136-41-026Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 10603295006978), received between Jun 22, 2017 and Jun 30, 2026 — classified as 54 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (14 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CONVERTED PATIENT FROM A TOTAL SHOULDER ARTHROPLASTY TO REVERSE SHOULDER ARTHROPLASTY. THEY REMOVED THE SIZE 10 PROXIMAL BODY, SIZE 44X15 STANDARD HUMORAL HEAD AND A SIZE 44 ANCHOR PEG GLENOID. THE PATIENT HAD A ROTATOR CUFF TEAR WHICH LED TO A CONVERSION OF A TSA TO AN RSA. AFFECTED SIDE-RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25664727 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO SUBSCAP FAILURE CONVERTED FROM A TOTAL SHOULDER TO REVERSE, KEEPING THE DISTAL STEM IN PLACE. AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25334740 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A SUBSCAP FAILURE. SURGEON CONVERTING ANATOMIC SHOULDER TO A REVERSE SHOULDER. NO KNOWN INFECTION, NO DELAY IN SURGERY, UNKNOWN LOT NUMBERS. DOI: (B)(6) 2018. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24859068 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS LEFT SHOULDER PAIN. SUBSCAP DYSFUNCTION.

  Patient problems: Pain

  MAUDE report 24402990 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ANATOMIC TO REVERSE REVISION NOT DUE TO IMPLANT FAILURE BUT TO ROTATOR CUFF WEAR. NO FURTHER INFORMATION KNOWN AT THIS TIME. PRODUCT LOTS ARE UNTRACEABLE THROUGH OPTIMIZE DUE TO LACK OF PRIOR CASE DGR. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24389147 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION PROCEDURE DUE TO POSTERIOR GLENOID FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 24048456 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SHOULDER REVISION DUE TO A FRACTURE. EXTRACTION OF DEPUY IMPLANTS. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Bone Fracture(s)

  MAUDE report 24011074 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE DUE TO A CUFF TEAR, DURING WHICH ALL COMPONENTS EXCEPT THE STEM WERE REMOVED AND THE CASE WAS CONVERTED FROM AN ANATOMIC SHOULDER TO A REVERSE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23688451 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION FROM A GLOBAL AP TO A DELTA EXTEND DUE TO CUFF TEAR AND SUPERIOR MIGRATION OF THE HUMERUS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23512097 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTS WERE REVISED TO CONVERT TO A REVERSE BECAUSE OF CUFF TEAR. ORIGINAL DATE OF SURGERY IS UNKNOWN. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23082611 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANATOMIC TO REVERSE SURGERY. THERE WAS ROTATOR CUFF FAILURE. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22937809 ↗
• MalfunctionMay 12, 2025Loss of or Failure to Bond; Improper or Incorrect Procedure or Method; Loss of or Failure to Bond; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE ANCHOR PEG GOT PULLED OFF AFTER IT WAS IMPLANTED ON TO THE GLENOID WITH CEMENT. SURGERY WAS DELAYED BY TEN MINUTES DUE TO THE EVENT. SURGEON USED A NEW IMPLANT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. IT WAS REPORTED THAT HE APG IMPLANT GOT PULLED OUT AFTER THE CEMENT WAS SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22003029 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CONVERSION TO REVERSE SHOULDER DUE TO ROTATOR CUFF FAILURE. NO IMPLANT LOOSENING OR FAILURE. DOI: (B)(6) 2017. DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT SHOULDER .

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21892348 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DATA USE AGREEMENT WAS RECEIVED WHICH INCLUDES SAFETY RELATED DATA ABOUT SURVIVORSHIP WORKSHEET 145 DEGREE EPIPHYSIS AND SHORT STEMS. 145 DEGREE EPIPHYSIS SUBJECTS SUBJECT #1: REPORTING A REVISION AT DAY 29 OF THE DELTA XTEND CUP AND GLENOSPHERE. UNKNOWN REASON FOR REVISION. GLENOSPHERE LOT: D20011257 CUP LOT: 5382816 SUBJECT #2: REPORTING A REVISION AT DAY 397 OF THE DELTA XTEND CUP AND GLENOSPHERE. UNKNOWN REASON FOR REVISION. GLENOSPHERE LOT: D19031580 CUP LOT: 5376548 SUBJECT #3: REPORTING A REVISION AT DAY 95. BASEPLATE REVISION WITH ILIAC CREST BONE GRAFT. UNKNOWN REASON FOR BONE GRAFT. METAGLENE LOT: 9724001 NON LOCKING SCREW LOT: 5378693 LOCKING SCREW LOT: 5375467 LOCKING SCREW LOT: 5379290 SUBJECT #4: REPORTING A REVISION AT DAY 251 OF THE DELTA XTEND CUP AND GLENOSPHERE. UNKNOWN REASON FOR REVISION. GLENOSPHERE LOT: D19082641 CUP LOT: 5372912 SHORT STEM SUBJECTS SUBJECT #1: REPORTING A REVISION AT DAY 29 OF THE DELTA XTEND CUP AND GLENOSPHERE. UNKNOWN REASON FOR REVISION. GLENOSPHERE LOT: D20011257 CUP LOT: 5382816 SUBJECT #2: REPORTING A REVISION AT DAY 397 OF THE DELTA XTEND CUP AND GLENOSPHERE. UNKNOWN REASON FOR REVISION. GLENOSPHERE LOT: D1903158

  Patient problems: Unspecified Infection

  MAUDE report 21306917 ↗
• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT STARTED HAVING TROUBLE WITH ELEVATION, WEAKNESS AND PAIN. NO SPECIFIC INJURY. IMPLANTS WERE IN GOOD CONDITION WITH NO ISSUES. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Fatigue; Loss of Range of Motion; Pain

  MAUDE report 21027954 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 20127870 ↗
• InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 19833700 ↗
• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED REVISION WAS COMPLETED DUE TO ROTATOR CUFF ARTHROPATHY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19689537 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SUBSCAPULARIS FAILURE. DOI - (B)(6) 2022. DOR - (B)(6) 2023. AFFECTED SIDE - LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16378202 ↗
• InjuryNov 7, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE GLOBAL UNITE SHOULDER WAS REMOVED AND REPLACED WITH A REVERSE SHOULDER DUE TO CUFF INSTABILITY AND MALPOSITIONING OF IMPLANTS. DOI: ON (B)(6) 2022, DOR: ON (B)(6) 2022, AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 15749384 ↗
• InjuryApr 20, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION COMPLETED DUE TO ASCEPTIC GLENOID LOOSENING. NO INFECTION. ALL IMPLANTS WERE REMOVED. THE SPACER WAS REMOVED AND REVISED TO A DELTA XTEND. DOI: (B)(6) 2020, DOR: (B)(6) 2022, LEFT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 14159134 ↗
• InjuryMar 1, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT HAS CUFF FAILURE AND INSTABILITY. SURGEON ALSO REALIZED GLENOID HAD COME LOOSE AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2012, DOR: (B)(6) 2022, RIGHT SHOULDER.

  Patient problems: Joint Laxity; Unspecified Musculoskeletal problem

  MAUDE report 13636235 ↗
• InjuryFeb 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TORE ROTATOR CUFF (SUB SCAP) NEEDED TO CONVERT TO REVERSE FOR STABILITY AND ROM. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT SHOULDER AFFECTED.

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

  MAUDE report 13584653 ↗
• InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. LOT NUMBER: GLOBAL UNITE HEAD 44X18 ECC (110044610/68660Z). B. WAS THE EVENT DUE TO NATURAL PROGRESSION? C. PLEASE CONFIRM THE QUANTITY OF DEPUY CMW 2 20G (3322020/9242374). ANSWER: LOT INFORMATION IS NOT AVAILABLE. IT IS NOT KNOWN IF ITS NATURAL PROGRESSION. IT WOULD HAVE BEEN DEPUY 2 & THE LOT # IS NOT KNOWN.

  Patient problems: Muscular Rigidity

  MAUDE report 12833126 ↗
• InjuryAug 17, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  (B)(6) ELECTED TO PERFORM A LEFT SHOULDER REVISION ARTHROPLASTY ON A PATIENT WHO HE PERFORMED A PRIMARY TOTAL SHOULDER ARTHROPLASTY ON AT (B)(6) ON (B)(6) 2010. (B)(6) NOTED THAT THE PATIENT PERFORMED WELL POST OPERATIVELY AFTER HER PRIMARY SHOULDER ARTHROPLASTY UNTIL 2018 WHEN SHE EXPERIENCE SEVERAL DISLOCATIONS. (B)(6) DID NOT SPECIFY THE EXACT NUMBER OF DISLOCATIONS OF THE LEFT SHOULDER. DOI: (B)(6) 2010, DOR: 2018. LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 12330425 ↗