GLOBAL UNITE 1100-44-610Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295004554), received between Sep 15, 2017 and May 22, 2026 — classified as 20 injuries, 1 malfunction.

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

8 other recalls cover devices cleared under the same FDA submission (K101996, 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT TORE HIS SUBSCAPULARIS AND HAD SURGERY TO REPAIR. SURGEON CHANGED UNITE HEAD FROM 44X18MM ECCENTRIC HEAD TO 48X18MM ECCENTRIC HEAD. DOI-(B)(6) 2026. DOR- (B)(6) 2026. AFFECTED SIDE-RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25254535 ↗
• 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 24445639 ↗
• 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 23407372 ↗
• 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 A RSA. DOI: (B)(6) 2017 DOR: (B)(6) 2025. AFFECTED SIDE : RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22359769 ↗
• 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 21856445 ↗
• InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: THERE WERE NO ALLEGATIONS AGAINST ANY DEVICE.

  Patient problems: Pain

  MAUDE report 21323982 ↗
• 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 21306922 ↗
• 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 20610494 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO ROTATOR CUFF DYSFUNCTION FOLLOWING LEFT SHOULDER HEMIARTHROPLASTY FOR FRACTURE. UNKNOWN SURGICAL DELAY. DOR: (B)(6) 2024 AFFECTED SIDE: LEFT SHOULDER

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18977770 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. IMPLANTS WERE EXPLANTED AND A CEMENT SPACER WAS PUT IN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2015, DOR: (B)(6) 2023; AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 16853896 ↗
• 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12833112 ↗
• 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 12135918 ↗
• InjuryJan 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED ON (B)(6) 2021 DUE TO LOOSENING OF THE GLENOID AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. IT IS NOTED THAT PATIENT HAS HAD PRIOR ARTHROSCOPIC EVALUATION ALONG WITH MANIPULATION FOR STIFFNESS AND PAIN. ON (B)(6) 2021 PATIENT HUMERAL HEAD WAS REMOVED AND REPLACED, AS WELL AS THE 44 GLENOID WHICH WAS CEMENTED WITH ALL THE PEGS INCLUDING THE CENTRAL PEG. PATIENT UNDERWENT A LEFT TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2020. A 44 GLENOID WAS IMPLANTED AT THAT TIME. DOI: (B)(6) 2020 DOR: (B)(6) 2021 LEFT SHOULDER.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 11253258 ↗
• InjuryMar 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN, STIFFNESS AND LOOSENING OF THE GLENOID COMPONENT AT CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. IT WAS ALSO REPORTED THAT THE HEAD WAS EXCHANGED AND A NEW 44 GLENOID WAS CEMENTED IN PLACE. DOI: (B)(6) 2019; DOR: (B)(6) 2020; LEFT SHOULDER.

  Patient problems: No Code Available; Pain

  MAUDE report 9806165 ↗
• InjuryDec 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. ROTATOR CUFF FAILURE AND CONVERSION TO A RTSA DONE. DOI: (B)(6) 2015 DOR: (B)(6) 2019 UNKNOWN SHOULDER.

  Patient problems: No Code Available; Pain

  MAUDE report 9425982 ↗
• InjuryAug 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL SHOULDER. DOI: UNK; DOR: (B)() 2018; UNKNOWN SHOULDER.

  Patient problems: Not Applicable; Pain

  MAUDE report 7767554 ↗
• MalfunctionMar 6, 2018Connection Problem; Positioning Problem; Connection Problem; Positioning Problem

  DER STATES THAT THE GLOBAL AP STEM WAS ASSEMBLED USING THE FIX 135 NECK ANGLE. THE SURGEON NOTICED AFTER IT WAS IMPLANTED THAT THE HEAD SAT PROUD . IT WAS REMOVED AND DISASSEMBLED. USING THE SAME STEM THEY CONVERTED IT TO A VARIABLE ANGLE AND THE WAS PREPARED AS PER TECHNIQUE BUT DID NOT MATCH THE TRIAL IMPLANT. THE SIZE 10 STEM WAS REPLACED WITH THE NEW STEM AND USED THE VARIABLE ANGLE AGAIN. THERE WAS A SURGICAL DELAY OF 20 MINUTES. DOE: (B)(6) 2018 RIGHT SHOULDER.

  Patient problems: Not Applicable

  MAUDE report 7315988 ↗
• InjuryJan 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. IT APPEARED TO BE BICEPS RELATED. DOI: (B)(6) 2017; DOR: (B)(6) 2018; RIGHT SHOULDER.

  Patient problems: Pain

  MAUDE report 7227101 ↗
• InjuryJan 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN. SURGEON CONVERTED THE PROXIMAL BODY TO A REVERSE SHOULDER. (B)(6) 2017; (B)(6) 2018 LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 7218184 ↗
• InjuryDec 8, 2017Disassembly; Disassembly

  DER STATES THAT THE HEAD DISASSOCIATED FROM HUMERAL HEAD CAUSING PAIN TO LEFT SHOULDER. DOI: UNKNOWN. DOR: (B)(6) 2017. LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 7099972 ↗
• InjurySep 15, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE HEAD OF UNITE SHOULDER HEAD DETACHED.

  Patient problems: No Information

  MAUDE report 6869788 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101996, K170748. One submission often covers many models, so check the product and lot details in each record.

• Z-0490-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
• Z-0486-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
• Z-0489-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
• Z-0484-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
• Z-0483-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
• Z-0485-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
• Z-0487-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
• Z-0488-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100