GLOBAL UNITE 1100-48-510Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295004585), received between Sep 20, 2017 and Feb 20, 2026 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT THE GLOBAL UNITE HEMI WAS REVISED TO REVERSE TSR DUE TO ROTATOR CUFF FAILURE. DOI: UNKNOWN DATE IN 2019, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24405390 ↗
• InjuryFeb 19, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT SHOULDER DISLOCATING, CONVERSION FROM GLOBAL UNITE TO DELTA XTEND. NO DELAY IN CASE. REMOVAL WENT EXCELLENT, CONVERSION WENT WELL. DOI-(B)(6) 2014, DOR-(B)(6) 2026, AFFECTED SIDE-UNKNOWN SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 24388986 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON REVISED THE FAILED FRACTURE HEMI TO REVERSE TOTAL SHOULDER. THERE WAS NO IMPLANT FAILURE, CUFF FAILURE. DOI-UNKNOWN, DOR (B)(6) 2025, AFFECTED SIDE- RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23305308 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT UNITE PROXIMAL BODY, HEAD, AND ANCHOR PEG GLENOID WERE REMOVED TO CONVERT TO A REVERSE TOTAL SHOULDER BECAUSE OF SUBSCAPULARIS DEFICIENCY. DOI: (B)(6), 2025. DOR: (B)(6), 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22608796 ↗
• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT HAD HER SHOULDER REPLACED SOMETIME AGO BY A SURGEON WHO IS UNKNOWN. THE PATIENT DID WELL INITIALLY AND THEN EXPERIENCED CUFF TEAR ARTHROPLASTY AND BEGAN TO LOOSE FUNCTION. THE SURGEON REVISED THIS ANATOMIC UNITE CONSTRUCT TO A DELTA REVERSE CONSTRUCT. THE HUMERAL HEAD, THE HUMERAL BODY, AND THE GLENOID COMPONENT WERE EXPLANTED AND REPLACED WITH REVERSE COMPONENTS. THE HUMERAL STEM WAS LEFT IN-SITU. THE ANCHOR GLENOID WAS NOT RECORDED ON THIS SHEET BECAUSE THE CATALOGUE AND LOT WERE ILLEGIBLE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17939677 ↗
• InjuryNov 30, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISION DUE TO PAIN.

  Patient problems: Not Applicable; Pain

  MAUDE report 8119470 ↗
• InjuryOct 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SHOULDER REPLACEMENT: (B)(6), (B)(6), (B)(6) 2018. ORIGINAL CASE (B)(6) 2017, (B)(6), SURGEON: (B)(6). REASON FOR REVISION: PAIN AND LACK OF FUNCTION. CONVERSION OF UNITE FRACTURE STEM TO DELTA EXTEND. REMOVED FRACTURE BODY AND HEAD, AND CONVERTED TO STANDARD DELTA EPI 1 LEFT, 38/3 HIGH MOBILITY STANDARD METAGLENE, AND 38 ECCENTRIC HEAD. WAS EXTREMELY HARD TO REDUCE, MAINLY AS ORIGINAL CASE LOOKED LIKE IT HAD BEEN CEMENTED TOO HIGH. FEMALE PATIENT INITIALS (B)(6), AGED (B)(6), DOB: (B)(6).

  Patient problems: No Code Available; Pain

  MAUDE report 8006261 ↗
• MalfunctionOct 10, 2018Defective Device; Defective Device

  THE SIZE OF THE IMPLANT IS WRONG.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7953052 ↗
• InjuryMar 9, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE REPORTED DEVICE WAS USED DURING THE PROSTHETIC ARTHROPLASTY OF SHOULDER JOINT ON (B)(6) 2017 DUE TO A SHOULDER FRACTURE. THE PATIENT WAS A (B)(6)-YEAR-OLD MALE. HIS RIGHT SHOULDER SURGERY WAS PERFORMED. POST-SURGICALLY, ON (B)(6) 2018, THE PATIENT REPORTED HAVING A SHOULDER PAIN. THE X-RAY IMAGES WERE TAKEN. IT WAS FOUND THAT THE HEAD OF THE REPORTED DEVICE HAD BEEN DISLODGED. ON (B)(6) 2018, THE REOPERATION WAS PERFORMED. THE HEAD AND COLOR WERE REMOVED, AND THE HEAD40X15 WAS REPLACED. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO DELAY IN SURGERY AND NO HARM TO THE PATIENT.

  Patient problems: Pain

  MAUDE report 7326610 ↗
• InjuryFeb 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2017; DOR: (B)(6) 2017; RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 7259046 ↗
• InjuryDec 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE UNKNOWN COMPONENT AT BONE TO CEMENT INTERFACE, DEPUY CEMENT WAS USED.

  Patient problems: Unspecified Infection

  MAUDE report 7084598 ↗
• InjuryNov 29, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7068937 ↗
• InjurySep 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6880084 ↗

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-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-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-0490-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
• 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-0489-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100