GLOBAL UNITE 1100-50-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295004639), received between Apr 23, 2018 and Jan 22, 2026 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT PATIENT WAS REVISED FROM ANATOMIC TO REVERSE DUE TO ROTATOR CUFF FAILING OVERTIME. NO FURTHER INFORMATION AVAILABLE. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24149992 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INCOMPETENT ROTATOR CUFF SO IMPLANT WAS REVISED FROM A PRIMARY TOTAL SHOULDER TO A REVERSE TOTAL SHOULDER. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23366150 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISE REVISED DUE TO PAIN. AND IT HAS APPEARED TO TEAR ROTATOR CUFF. PLAN IS TO CONVERT PATIENT TO REVERSE TSA. SURGICAL DELAY UNKNOWN. ACTIVITY LEVEL - YES . DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 19721721 ↗
• 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 19689543 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF TOTAL SHOULDER REPLACEMENT - CONVERTED TO REVERSE SHOULDER DUE TO ROTATOR CUFF FAILURE CAUSING PAIN AND REDUCED FUNCTION. RIGHT SHOULDER ALL COMPONENTS EXPLANTED AND REPLACED WITH REVERSE SHOULDER. DOI: (B)(6) 2022 DOE: (B)(6) 2024.

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

  MAUDE report 18857363 ↗
• InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S TOTAL SHOULDER WAS REVISED DUE TO CUFF TEAR. THERE WAS NO LOOSENING REPORTED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16876663 ↗
• InjuryDec 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD SHOULDER HEMIARTHROPLASTY PERFORMED IN 2014, IT HAS RECENTLY BECOME UNSTABLE AND REQUIRED REVISION TO TOTAL. SUPERIOR-POSTERIOR WHICH REQUIRED CORRECTION WHEN REAMING, ALSO THE PROXIMAL BODY WAS REVISED FROM 135DEG TO 142DEG TO HELP IMPROVE STABILITY FURTHER. DOI: 2014. DOR: (B)(6) 2022. UNKNOWN SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 16033375 ↗
• InjuryOct 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT TORE HIS SUBSCAPULARIS AND NEEDED TO CONVERT TO A REVERSE. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15697585 ↗
• MalfunctionJun 23, 2022Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A DELIVERY WHERE THE PLASTIC WRAPPING OF THE PRODUCT BOX WAS LOOSE AND SOMEHOW DAMAGED, THE CUSTOMER DID NOT DARE TO USE IT BECAUSE IT CAN BE NON-STERILE NOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14788727 ↗
• InjuryMar 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HIS SHOULDER REPLACED BY SURGEON SOMETIME AGO .THE PATIENT HAD A GLOBAL UNITE CONSTRUCT IMPLANTED. THE PATIENT DID WELL INITIALLY BUT INJURED HIS ROTATOR CUFF AND LOST ROM OVER TIME. IT WAS DECIDED THAT SURGEON WOULD CONVERT THE ANATOMIC CONSTRUCT TO A REVERSE CONSTRUCT. THE APG , HUMERAL HEAD, AND PROXIMAL BODY WERE EXPLANTED DURING THE REVISION SURGERY. THE STEM WAS LEFT IN SITU AND A DELTA REVERSE CONSTRUCT WAS IMPLANTED. THE ORIGINAL IMPLANT DATE IS UNKNOWN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT SHOULDER.

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

  MAUDE report 13667197 ↗
• InjuryJun 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SINGLE STAGE REVISION OF GLOBAL UNITE ANATOMIC SHOULDER REPLACEMENT DUE TO CONFIRMED INFECTION. HUMERAL HEAD, PROXIMAL BODY AND GLENOID COMPONENT REMOVED, AREA FLUSHED, NEW IMPLANTS PUT IN. DOI: (B)(6) 2020. DOR: (B)(6) 2021; RIGHT SHOULDER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11945826 ↗
• InjuryMar 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO A CUFF TEAR. TOTAL SHOULDER REVISED TO A REVERSE. WHILE IN REVISION, IT WAS NOTICED THAT PART NUMBER 230785000 WAS IN THE JOINT FROM THE PRIOR SURGERY. DOI: (B)(6) 2020. DOR: (B)(6) 2020; RIGHT SHOULDER.

  Patient problems: No Code Available

  MAUDE report 9878732 ↗
• InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015: PATIENT UNDERWENT A RIGHT TSA WITH A DEPUY IMPLANT-GLOBAL UNITE SECONDARY TO ARTHRITIS AND MILD POSTERIOR SUBLUXATION. NO INTRAOPERATIVE COMPLICATIONS NOTED. CEMENT MANUFACTURER IS UNKNOWN. ON (B)(6) 2015: PATIENT SEEN IN OFFICE SECONDARY TO SWELLING AND PAIN. THE DOCTOR ALSO REPORTED HIS ULTRASOUNDS ¿SHOWED SOME CLOTS IN UPPER ARM VEINS¿ AND WAS TREATED WITH ASPIRIN. NO FURTHER INTERVENTIONS PROVIDED OR INDICATED. HE WAS ALSO DIAGNOSED WITH A RIGHT RUPTURED ROTATOR CUFF AND WAS TREATED WITH A LIDOCAINE INJECTION AND KENALOG INJECTION. ON (B)(6) 2015: THE PATIENT WAS SEEN IN OFFICE SECONDARY TO SWELLING AND PAIN. PATIENT REPORTS APPOINTMENT WITH PA IN HIS FAMILY PHYSICIAN¿S OFFICE SUSPECTS PHLEBITIS AND NOT A BLOOD CLOT. PATIENT TREATED WITH FULL ASPIRIN DAILY. PATIENT ALSO DIAGNOSED WITH BURSITIS OF RIGHT ELBOW. AND RECEIVED ASPIRATION OF THE RIGHT ELBOW WITH REMOVAL OF 25-30 CC OF FLUID. ON (B)(6) 2015: PATIENT WAS SEEN IN OFFICE DUE TO SWELLING IN RIGHT HAND AND ARM; WITH 1 TO 2+ PITTING EDEMA IN THE BACK OF HIS HAND AND IS INTERFERING WITH THE ABILITY TO OPEN AND CLOSE HIS HAND. BASED ON THIS INFORMATION, THE PATIENT WAS DIAGNOSED WITH LYMPHEDEMA AND REFERRED OU

  Patient problems: Edema; Muscular Rigidity; No Code Available; Pain

  MAUDE report 9738424 ↗
• InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD ANATOMIC TOTAL SHOULDER REPLACEMENT, WITH SUBSEQUENT ROTATOR CUFF FAILURE, REQUIRING CONVERSION TO REVERSE SHOULDER REPLACEMENT.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9713920 ↗
• InjuryNov 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PARTIAL CUFF TEAR. GLOBAL UNITE PRIMARY CONVERTED TO REVERSE. DOI: (B)(6) 2018; DOR: (B)(6) 2019; RIGHT SHOULDER.

  Patient problems: No Code Available

  MAUDE report 9289938 ↗
• InjuryApr 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LIMITED MOBILITY. DOI: (B)(6) 2015; DOR: (B)(6) 2018; LEFT SHOULDER.

  Patient problems: Loss of Range of Motion; Not Applicable; Pain

  MAUDE report 7450715 ↗

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-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-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-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-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
• 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