GLOBAL UNITE 1100-30-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10603295004356), received between Sep 20, 2017 and Feb 25, 2026 — classified as 30 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

9 other recalls cover devices cleared under the same FDA submission (K133834, K170748); they may or may not involve this specific model.

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 37 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH THE CONVERSION OF SHOULDER FROM ANATOMIC TO REVERSE DUE TO ROTATOR CUFF FAILURE. NO OTHER INFORMATION KNOWN AT THIS TIME. DOI: (B)(6) 2022. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24445556 ↗
• 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 24403023 ↗
• 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 24119218 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENTS' ROTATOR CUFF FAILED AND NEEDED CONVERSION TO A REVERSE DELTA XTEND SHOULDER. HUMERAL HEAD IMPLANT AND PROX BODY IMPLANT WERE RETRIEVED WITH NO DEFORMITIES, DAMAGE, OR LOSS OF FIXATION. NO OTHER INFORMATION IS KNOWN AT THIS TIME. LOT NUMBERS ARE UNKNOWN. DOI: (B)(6) 2021, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23920872 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS SUBSCAP FAILURE. IT WAS PUT IN REVERSE. THIS WAS A SUBSCAP FAILURE NOT CEMENT ISSUE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23401444 ↗
• 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 23368985 ↗
• 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 22937751 ↗
• 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 22359812 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A SHOULDER HEMIARTHROPLASTY (B)(6) 2017. RECENTLY COMPLAINING OF SHOULDER PAIN-ROTATOR CUFF INSTABILITY FOUND ON MRI. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity; Pain; Unspecified Tissue Injury

  MAUDE report 22157804 ↗
• 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 21994083 ↗
• 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 21976238 ↗
• InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME TO THE SURGEON WITH COMPLAINT OF PAIN IN RIGHT SHOULDER. THE PATIENT HAD A HEMI SHOULDER REPLACEMENT APPROXIMATELY 8 YEARS AGO WHERE THE PATIENT HAD A GLOBAL UNITE STEM, PROXIMAL BODY AND HEAD IMPLANTED. THE SURGEON DETERMINED THAT THE PATIENT NEEDED TO BE CONVERTED TO A REVERSE SHOULDER. DURING THE REVISION SURGERY, THE SURGEON REMOVED THE HUMORAL HEAD AND THE PROXIMAL BODY. IT WAS NOTED THAT THE COMPONENTS WERE WELL FIXED. THE SURGEON PREPARED THE PROXIMAL HUMERUS FOR A SZ 1 EPIPHYSIS AND IMPLANTED THE SZ 1 CENTRAL EPIPHYSIS AND A SZ 42 +3 POLY CUP. ON THE GLENOID, HE USED LINK METAGLENE AND 42MM GLENOSPHERE. IT WAS NOTED WHEN ALL IMPLANTS WERE IN, THE PATIENT SHOULDER WAS STABLE AND HAD GREAT RANGE OF MOTION. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Pain

  MAUDE report 21323979 ↗
• 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

  Patient problems: Unspecified Infection

  MAUDE report 21306919 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CUFF HAS TORN AND PATIENT WAS REVISED TO A REVERSE SHOULDER. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20204447 ↗
• 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 20127871 ↗
• InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A HEMI ARTHROPLASTY WITH GLOBAL UNITE IMPLANTS AS A RESULT OF A FRACTURE IN 2022. DUE TO PAIN AND POOR FUNCTION, SURGEON CONVERTED TO A DELTA XTEND REVERSE TSA TODAY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 20008379 ↗
• InjuryMar 26, 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 18980545 ↗
• 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 18443468 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. PATIENT HAD HIS LEFT SHOULDER REPLACED SOMETIME AGO, THE EXACT DATE IS UNKNOWN AT THIS TIME. PATIENT DID WELL INITIALLY, OVER THE LAST YEAR, THE PATIENT LOST RANGE OF MOTION, AND EXPERIENCE, PAIN AND DISCOMFORT. SURGEON STATED THE PATIENT HAD A REPAIRABLE ROTATOR CUFF TEAR, AND THAT HE WOULD NEED TO CONVERT THE ANATOMIC CONSTRUCT TO A REVERSE CONSTRUCT. THE ANATOMIC PROXIMAL BODY WAS EXPLANTED ALONG WITH A HUMERAL HEAD, AND ANATOMIC GLENOID. THE HUMERAL SAM WAS LEFT IN SITU. A REVERSE, PROXIMAL BODY, HUMERAL CLUB WARREN PLANTED ONTO THE STEM, A REVERSE BASE PLATE, WITH A GLENOSPHERE WAS IMPLANTED INTO THE GLENOID FOR A REVERSE SHOULDER CONSTRUCT. LOT NUMBERS FOR THE ANATOMIC AND GLENOID AND HUMERAL STEM WERE UNABLE TO BE RECORDED. THERE WAS NO SURGICAL DELAY AS A RESULT OF PRODUCTS. ACTIVITY LEVEL - YES. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

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

  MAUDE report 18138709 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS WAS A TSA PERFORMED ON (B)(6) 2023. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2023, THE PATIENT COMPLAINED OF PAIN. ON (B)(6) 2023, IT WAS CONFIRMED THAT THE GREATER TUBERCLE WAS DISPLACED AROUND THE TOP OF THE HEAD. THEREFORE, THE SURGEON DECIDED TO PERFORM REVISION SURGERY INSTEAD OF PRESERVATION. ON (B)(6) 2023, A REVISION SURGERY WAS PERFORMED. THE SURGEON ASSUMED THE WORST AND STARTED THE SURGERY WITH THE POSSIBILITY OF REPLACING RSA. ONLY THE BODY AND HEAD WERE REPLACED. IT WAS LOCKED WITH SOFT ANCHOR. A BURR HOLE WAS CREATED IN SHAFT. PERMATEPE AND DYNATAPE WERE PLACED OVER THE ROTATOR CUFF AND INSERTED INTO THE BURR HOLE, HOLDING THE GREATER TUBERCLE, IN PLACED AND LOCKED. DOI: (B)(6) 2023; DOE: (B)(6) 2023; AFFECTED SIDE: UNKNOWN.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 17117793 ↗
• InjuryNov 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use 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: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 15749146 ↗
• InjurySep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND LIMITED RANGE OF MOTION. DID A CONVERSION FROM A TOTAL SHOULDER TO A REVERSE. NO ADDITIONAL INFORMATION. THERE WAS NO LOOSENING EXPERIENCED AND THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 15392388 ↗
• 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 15084406 ↗
• 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 14112407 ↗
• InjuryDec 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOW GRADE INFECTION WHICH CAUSED STEM TO MOVE INTO VALGUS. DOI: (B)(6) 2017, DOR: (B)(6) 2021, RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 12953493 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133834, K170748. One submission often covers many models, so check the product and lot details in each record.

• Z-0485-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
• Z-0483-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
• Z-0487-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
• Z-0484-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
• Z-0489-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
• Z-0488-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
• Z-0486-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
• Z-0490-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
• Z-1012-2018 · Nov 28, 2017 · Terminated
  The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling: LEO-1100-30-000 REV D.pd