GLOBAL UNITE 1100-10-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10603295004080), received between Jul 26, 2017 and Sep 16, 2026 — classified as 22 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (5 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-0486-2022 · 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 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient had a mid humeral fracture.DOI: (b)(6) 2026.DOR: (b)(6) 2026. Affected Side: Right Shoulder.

  Patient problems: Bone Fracture(s)

  MAUDE report 50792462 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INCREASED PAIN DUE TO HUMERAL FRACTURE. SURGEON REMOVED A SIZE 10 GLOBAL UNITE STEM, 145 SIZE 1 CENTERED EPIPHYSIS, AND A 38 +3 STANDARD HUMERAL CUP. SURGEON THEN CEMENTED A SIZE 10 GLOBAL UNITE REVISION STEM, 145 SIZE 1 CENTERED EPIPHYSIS, AND A 38 +3 STANDARD HUMERAL CUP. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 24179928 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION, SO SURGEON DECIDED TO REMOVED IMPLANTS AND PUT IN A HEMI SHOULDER. THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 23815143 ↗
• InjuryNov 26, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE SHOULDER FAILED. IT WAS LOOSE APG AND STEM. THERE WAS NO INFECTION AND NO HARM TO PATIENT. THERE WAS NO DELAYS. IT WAS CONVERTED TO A REVERSE. THERE WAS NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23657704 ↗
• MalfunctionNov 5, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT BOTH PRODUCTS COULD NOT BE PROPERLY CONNECTED TO EACH OTHER. THERE WAS A REMAINING GAP OF 2CM. NO APPRECIABLE OP TIME DELAY. NO PATIENT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478927 ↗
• MalfunctionMay 30, 2025Difficult to Insert; Difficult to Insert

  DOING A GLOBAL UNITE REVERSE TOTAL SHOULDER (LEFT); STEM AND EPI WOULD NOT MATE. SEEMS TO BE A MISMATCH OR MACHINING ISSUE. ANOTHER STEM AND EPI WERE OPENED AND THE COMBINATION WORKED AS EXPECTED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIVE-MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116939 ↗
• MalfunctionFeb 11, 2025Corroded; Device Damaged Prior to Use; Corroded; Device Damaged Prior to Use

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: WAS THE SEAL BROKEN/STERILE INTEGRITY OF THE PACKAGE BREACHED? THE PACKAGING LOOKED INTACT AND NOT DAMAGED AT ALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355620 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REMOVAL OF IMPLANTS DUE TO INFECTION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. ACTIVITY LEVEL - YES DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 21072940 ↗
• MalfunctionDec 6, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED, THAT DURING A TOTAL SHOULDER PROCEDURE. THE GLOBAL UNITE STEM WOULD NOT MATE WITH THE EPI PROXIMAL BODY. THERE WAS A SPACE IN BETWEEN THE TWO IMPLANTS. ANOTHER STEM WAS OPENED AND IT MATED PERFECTLY WITH THE PROXIMAL IMPLANT. THERE WAS A 5 MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20868518 ↗
• 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. ACCORDING TO THE SURGEON, OTHER POSSIBLE CAUSES BESIDES THE PRODUCTS ARE THE ANGLE OF THE POSTERIOR TWIST AND THE GREATER TUBERCLE INJURY DURING THE RETRACTOR OPERATION. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2023; DOE: (B)(6) 2023; AFFECTED SIDE: UNKNOWN.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 17117785 ↗
• InjuryNov 7, 2022Use of Device Problem; Use of Device 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; Unspecified Tissue Injury

  MAUDE report 15748321 ↗
• InjurySep 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO A PERIPROSTHETIC FRACTURE. THE STEM WAS REMOVED TO FIX THE FRACTURE AND A LONG MONOBLOC STEM WAS CEMENTED IN. NO OTHER INFORMATION. THERE WAS NO SURGICAL DELAY. THERE WAS NO LOOSENING REPORTED. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Bone Fracture(s)

  MAUDE report 15410906 ↗
• 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 15084424 ↗
• InjuryDec 7, 2021Migration; Migration

  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 12953494 ↗
• MalfunctionJul 2, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT WHEN ATTEMPTING TO CONNECT THE SIZE 1 EPI TO THE GLOBAL UNITE SIZE 10 STEM, THE TWO IMPLANTS WOULD NOT CONNECT DUE TO A MISMATCH OF THE STEM AND HOLE USED TO CONNECT THE 2 IMPLANTS. THE IMPLANTS WERE THEN REMOVED FROM THE FIELD AND TWO NEW IMPLANTS WERE PRESENTED TO THE FIELD. THERE WAS NO DELAY IN SURGERY AND THE IMPLANTS ON THIS REPORT WERE NEVER IMPLANTED IN THE PATIENT. DOE: (B)(6) 2021, UNKNOWN AFFECTED SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12108375 ↗
• MalfunctionJan 27, 2021Difficult to Insert; Difficult to Insert

  AFTER THE SURGEON IMPLANTED THIS STEM HE WENT TO TRIAL THE VARIOUS PROXIMAL BODIES HOWEVER HE FOUND NONE OF THE BODIES WOULD CONNECT TO THE STEM. THE SURGEON THEN TRIALLED THE PROXIMAL BODIES WITH THE VARIOUS TRIAL STEMS AND THEY ALL FIT PERFECTLY. SURGEON HAD TO REMOVE THIS IMPLANT AND INSERT ANOTHER HOWEVER WE DIDN¿T HAVE THE SAME STEM AVAILABLE SO HE HAD TO USE A SIZE 10 REVISION STEM WHICH WASN¿T IDEAL FOR THE PATIENT. NO X-RAYS AVAILABLE. SURGERY DELAY OF 20 MINS. THE SURGEON WILL BE SENDING OFF FOR IN-HOSPITAL INVESTIGATION.

  Patient problems: Insufficient Information

  MAUDE report 11237592 ↗
• InjurySep 16, 2020Loss of Osseointegration; Malposition of Device; Naturally Worn; Loss of Osseointegration; Malposition of Device; Naturally Worn

  REASON FOR REVISION: ASEPTIC LOOSENING LEADING TO DISLOCATION, PAIN & OSTEOLYSIS. THE REASON FOR REVISION IS DISLOCATION. THE CAUSE OF THE DISLOCATION IS UNCERTAIN. SHE IS DEMENTED, AND THERE IS AN X-RAY DOCUMENTING A REDUCED JOINT THREE WEEKS AGO. THE JOINT HAS BEEN PAINFUL. HUMERAL COMPONENT MAY BE LOOSE. PATIENT WILL BE REVISED TO A CEMENTED HUMERAL COMPONENT, THOUGH STABILITY MAY STILL BE AN ISSUE. ATTENDED REVISION CASE. PRIMARY PE CUP AND HUMERAL STEM WERE WORN AND EXPLANTED. SURGEON NOTED 'TARNISHING" TO THE GLENOSPHERE, BUT OPTED TO LEAVE IT IN-SITU DUE TO PATIENT FRAILTY DESPITE ADVICE TO EXCHANGE IT. CEMENTED DELTA XTEND (LONG STEM) USED WITH NEW PE CUP DURING REVISION TO RESTORE FUNCTION. SURGEON BELIEVES THAT OSEO-INTEGRATION OF THE PRIMARY HUMERAL STEM NEVER FULL OCCURED SO STEM BECAME LOOSE AND MAL-ROTATED CAUSING IMPLANT IMPINGEMENT & METAL ON METAL CONTACT/WEAR LEADING TO FURTHER ASEPTIC LOOSENING AND SUBSEQUENT OSTEOLYSIS AND DISLOCATION. ACTION TAKEN :THE PATIENT REQUIRED A REVISION TO A CEMENTED DELTA XTEND LONG STEM WITH NEW PE CUP. PATIENT CONDITION: DEMENTIA. FEMALE PATIENT INITIALS: M.M HEIGHT 180CM WEIGHT (B)(6).

  Patient problems: Inadequate Osseointegration; Joint Disorder; No Code Available; Pain

  MAUDE report 10541699 ↗
• InjurySep 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS FALL, FRACTURED HUMERUS AT THE STEMS TIP. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2016, DOR: (B)(6) 2020, LEFT SHOULDER.

  Patient problems: Bone Fracture(s); Fall; No Code Available

  MAUDE report 10501838 ↗
• InjuryJun 19, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. THE SURGEON WAS PLANNING ON DOING AN I&D OF A REVERSE TSA AND ONCE HE GOT INTO THE SHOULDER JOINT, THE PRESSFIT GLOBAL UNITE STEM WAS LOOSE SO HE TOOK OUT THE STEM, MODULAR EPIPHYSIS, HUMERAL CUP AND LATERALIZED GLENOSPHERE AND IMPLANTED A NEW LATERALIZED GLENOSPHERE, CEMENTED MONOBLOC STEM AND A HUMERAL CUP. NO HEIGHT AND WEIGHT WAS AVAILABLE AT THAT TIME. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration; No Code Available; Unspecified Infection

  MAUDE report 10175392 ↗
• InjuryFeb 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LACK OF ROM. DOI: (B)(6) 2019; DOR: (B)(6) 2020; LEFT SHOULDER.

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

  MAUDE report 9764064 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BEING CONVERTED FROM A GLOBAL UNITE TO DELTA CONSTRUCT DUE TO FRACTURE STEM. NO FURTHER PATIENT INFORMATION AVAILABLE. DOI: (B)(6) 2019. DOR: (B)(6) 2019; LEFT SHOULDER.

  Patient problems: No Code Available

  MAUDE report 9538755 ↗
• InjuryAug 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. THE HUSBAND OF THE PATIENT THOUGHT THE INFECTION WAS CAUSED BY THE IMPLANT. DOI: (B)(6) 2019; DOI: (B)(6) 2019 (PE CUP); DOR: (B)(6) 2019, RIGHT SHOULDER.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8910559 ↗
• InjuryJul 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2019. DOR: (B)(6) 2019, RIGHT SHOULDER.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8815965 ↗
• InjuryJun 14, 2019Fitting Problem; Device-Device Incompatibility; Fitting Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT WHILE CONVERTING A GLOBAL UNITE TO A REVERSE , IT WAS NOTICED THAT THE UNITE PROXIMAL BODY WAS COLD WELDED AND 2 SCREW DRIVERS WERE BROKEN TRYING TO GET IT APART . THE REVERSE SCREW DRIVER WAS DAMAGED TRYING WHILE INSERTING THE LOCKING SCREW. THIS MDR INCLUDES THE IMPLANTS THAT WERE REMOVED. DOI: UNKNOWN. DOR: (B)(6) 2019; UNKNOWN SHOULDER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available; Not Applicable

  MAUDE report 8699576 ↗
• InjuryJan 19, 2018Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS SPUN AND LOOSENING OF THE UNITE STEM AT THE BONE TO IMPLANT INTERFACE. (B)(6) 2017; (B)(6) 2017 RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7206184 ↗

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