GLOBAL UNITE 1100-12-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10603295004127), received between Dec 8, 2017 and Sep 30, 2026 — classified as 27 injuries, 2 malfunctions.

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

1 FDA recall record name this device's identifier.

7 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.

Recalls naming this device

1. Dec 7, 2021Class IITerminated

   Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

   Z-0488-2022 · Root cause: Equipment maintenance · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

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

  It was reported that patient had left anatomic total shoulder approximately 10 years ago. Original date of surgery and hospital are unknown. Patient developed rotator cuff arthropathy and was revised to a reverse total shoulder.DOI: Unknown. DOR: (b)(6) 2026.Affected side: Left shoulder.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50944837 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50923266 ↗
• InjurySep 17, 2026Osseointegration Problem

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 50810889 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHOULDER REVISED FOR BASEPLATE LOOSENING DUE TO INFECTION. 48MM ANTIBIOTIC SPACER IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24494236 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. SURGEON REMOVED ALL COMPONENTS AND INSERTED ANTIBIOTIC SPACER. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 24307566 ↗
• 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 24010837 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT TORE ROTATOR CUFF AND NEEDED TO BE CONVERTED TO A REVERSE - ANOTHER SYSTEM WAS USED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24010834 ↗
• MalfunctionOct 31, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO CONNECT THE EPIPHYSIS AT THE STEM´S PROXIMAL PEG. ANOTHER STEM WAS USED WITHOUT ANY ISSUE. THERE WAS NO SURGICAL DELAY AND NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. SURGERY WAS FINISHED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23434573 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION OF SHOULDER. ALL IMPLANTS REMOVED. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22717434 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S SHOULDER BECAME INFECTED AND HARDWARE NEEDED TO BE REMOVED. DOI: (B)(6) 2022, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22160853 ↗
• 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 21892040 ↗
• InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE 1ST STAGE REVISION DUE TO INFECTION AND 3 IMPLANTS WERE REMOVED. ORIGINAL OPERATION DUE TO HUMERAL FRACTURE. IMPLANTS USED GLOBAL UNITE FRACTURE HEMI ARTHROPLASTY RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 21337278 ↗
• InjuryJul 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WHAT WAS THE PRIMARY REASON FOR REVISION? WAS IT PAIN OR INFECTION OR INSTABILITY? B. WAS THE PATIENT REVISED FOR PAIN AND INFECTION FOUND UPON REVISION ? OR INFECTION WAS FOUND EARLIER? "IT WAS REVISED FOR PAIN AND FOUND INTRAOPERATIVELY TO BE GROSSLY INFECTED. "

  Patient problems: Joint Laxity; Pain; Unspecified Infection

  MAUDE report 19781958 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO DOTS CLINICAL ADVERSE EVENT RECEIVED FOR SUSPICION OF PROSTHETIC INFECTION - LEFT SHOULDER. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE OR PROCEDURE. DATE OF IMPLANT: (B)(6) 2024 DATE OF EVENT: (B)(6) 2024 (LEFT SHOULDER). TREATMENT: I&D NO REVISION COMPLETED.

  Patient problems: Unspecified Infection

  MAUDE report 19562925 ↗
• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 17939757 ↗
• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A RIGHT DELTA XTEND REVISION FOR INFECTION. ALL COMPONENTS REMOVED AND CEMENT SPACER PUT IN. PROCEDURE SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. DATE OF ORIGINAL SURGERY WAS (B)(6) 2023.

  Patient problems: Unspecified Infection

  MAUDE report 17894108 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 17747269 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 17191582 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN IN SHOULDER REGION AFTER SHOULDER REPLACEMENT; CHRONIC PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2020. DATE OF EVENT: (B)(6) 2020. (RIGHT SHOULDER). TREATMENT: INITIAL WORK UP FOR INFECTION WITH BLOOD WORK.

  Patient problems: Loss of Range of Motion; Nerve Damage; Numbness; Pain; Paresthesia; Unspecified Infection

  MAUDE report 15951610 ↗
• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND LACK OF ROM. PATIENT HAD PREVIOUS PROXIMAL HUMERUS FX AND THE SURGEON USED UNITE FX STEM, SUTURE COLLAR, AND HUMERAL HEAD IMPLANTS. SURGEON THEN REVISED THE HEMI SHOULDER TO A REVERSE TOTAL SHOULDER WITH A DIFFERENT COMPANY (TORNIER). THERE WERE NO DEFICIENCIES SUGGESTED AND NO DELAY IN PROCEDURE. IMPLANTS WERE NOT AVAILABLE FOR RETURN. DOI: (B)(6) 2017. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 14944536 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AND REVIEWED: IT IS NOTED THE DATE OF LEFT SHOULDER MANIPULATION UNDER ANESTHESIA OCCURRED ON (B)(6) 2020. IN ADDITION TO THE PREVIOUSLY REPORTED ISSUES, THE PATIENT WAS ALSO EXPERIENCING THE FOLLOWING ADVERSE SYMPTOMS PRIOR TO LEFT SHOULDER MANIPULATION UNDER ANESTHESIA ON (B)(6) 2020: PAIN, DISCOMFORT, DECREASED RANGE OF MOTION, AND WEAKNESS. EVALUATION NOTES FOLLOWING THE LEFT SHOULDER MANIPULATION REVEALED IMPROVING SYMPTOMS.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Fatigue; Loss of Range of Motion; Pain

  MAUDE report 11176069 ↗
• InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS TREATED WITH A RIGHT SHOULDER PROSTHETICS ON THE (B)(6) 2020 DUE TO AN UNKNOWN REASON. DURING RECOVERY THE PATIENT RECEIVED A CLOSED REDUCTION TO TREAT A PAIN AND INSTABILITY SECONDARY TO A DISLOCATION CAUSED BY A FALL. THE RECOVERY COURSE HAS BEEN COMPLICATED BY A COVID INFECTION. THE PATIENT WILL BE REVISED IN (B)(6) 2021 AFTER A NICKEL FREE IMPLANT IS RECEIVED DUE TO THE PATIENT'S NICKEL ALLERGY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Fall; Joint Laxity; Loss of Range of Motion; Pain; Pneumonia

  MAUDE report 11056832 ↗
• InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN DUE TO INFECTION. DOI: (B)(6) 2020; DOR: (B)(6) 2020; RIGHT SHOULDER.

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

  MAUDE report 10905943 ↗
• MalfunctionFeb 20, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2014: PATIENT UNDERWENT A RIGHT RTSA WITH A DEPUY IMPLANT, GLOBAL UNITE AND DELTA XTEND SECONDARY TO A HUMERUS FRACTURE. PATIENT ALSO HAD OPEN REDUCTION BONE GRAFTING AND CLEANING OUT OF SYNOVIAL PSEUDARTHROSIS PERFORMED. NO INTRAOPERATIVE COMPLICATIONS. CEMENT MANUFACTURER NOT SPECIFIED. ON (B)(6) 2015: THE PATIENT WAS SEEN FOR THE FIRST TIME POSTOPERATIVELY. THE SURGEON¿S NOTES REVEAL THAT IS DUE TO THE PATIENT HAVING A PORT PLACED FOR DIALYSIS AND SOME MENTAL STATUS CHANGES. UPON PHYSICAL EXAMINATION, THE HUMERAL SHAFT NONUNION IS COMPLETELY HEALED, HOWEVER, THE RIGHT HUMERUS IS DETERMINED TO BE DISLOCATED MEDIALLY; IT DOES NOT MOVE AT ALL, THE PATIENT DOES NOT REPORT PAIN AND HE IS ABLE TO FUNCTION WITHIN FUNCTIONAL LIMITS. NO TREATMENT INDICATED AND FOLLOW-UP AGAIN IN THREE MONTHS. PMH: ROTATOR CUFF TEAR, SYNOVIAL PSEUDARTHROSIS, CORONARY BYPASS GRAFTING. DOI: (B)(6) 2014 (RTSA). DOE: (B)(6) 2015 (FOLLOW-UP).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9732149 ↗
• InjuryJul 29, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT PRESENTED IN DR. S OFFICE WITH A PAINFUL RIGHT SHOULDER THAT DR HAD TREATED ON (B)(6) 2016 FOR A FOUR PART PROXIMAL HUMERAL FRACTURE. DR. SUSPECTED A POSSIBLE INFECTION AND ELECTED TO PERFORM A TWO STAGE SHOULDER REVISION. ON (B)(6) 2019, DR REMOVED INDEX COMPONENTS AT (B)(6) AND INSERTED A HANDMADE ANTIBIOTIC CEMENT SPACER. THE CEMENTED HUMERAL STEM ASSEMBLY CAME OUT CLEAN WITHOUT ANY CEMENT ATTACHED BY HAND. UNKNOWN CEMENT WAS USED AT TIME OF INDEX SURGERY. DR USED STANDARD DELTA EXTEND INSTRUMENTATION TO REMOVE THE GLENOSPHERE AND METAGLENE THAT WERE WELL FIXED. NO INSTRUMENTATION BROKE DURING SURGERY. THERE WERE NO TIME DELAYS. AND THERE WAS NO INDICATION BY DR OR STAFF THAT THE PRODUCTS WERE DEFICIENT OR THE REASON FOR THE NEED FOR REVISION.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 8837048 ↗

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