GLOBAL UNITE 1100-08-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10603295004042), received between Aug 18, 2017 and May 2, 2025 — 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-0484-2022 · 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.

• InjuryMay 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO MECHANICAL FAILURE/DISLOCATION AFTER HAVING MULTIPLE SCLEROSIS. SURGICAL DELAY IS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2025 , AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 21955143 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT SHOULDER GLOBAL UNITE ANATOMIC IMPLANT WAS IN SITU BUT HAS FAILED AND ROTATOR CUFF NON FUNCTIONING. A REVERSE SHOULDER REPLACEMENT WAS THEREFORE REQUIRED SO THE ANATOMIC IMPLANTS WERE REPLACED WITH REVERSE SHOULDER IMPLANTS. THE HEAD, COLLAR AND FRACTURE EPIPHYSIS WERE REMOVED DURING THE REVISION SURGERY AND REPLACED WITH A DELTA XTEND EPIPHYSIS AND PE CUP. THERE WAS NO DELAY TO PROCEDURE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21747806 ↗
• InjuryJan 8, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT CONTRACTED AN INFECTION, SO ALL IMPLANTS WERE REMOVED AND A ANTIBIOTIC SPACER WAS PUT IN PLACE. THERE WAS STEM LOOSENING AT NON-CEMENT INTERFACE. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOE: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 21104842 ↗
• InjuryApr 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS WAS A PRIMARY SURGERY PERFORMED ON (B)(6) 2019. AFTER SURGERY, IT WAS CONFIRMED THAT GREATER TUBERCLE WAS ATROPHIED. THEREFORE, THE IMPLANTS WILL BE REMOVED, AND RSA WILL BE PERFORMED BY OTHER COMPANY¿S PRODUCT. THE REVISION SURGERY DATE IS (B)(6) 2023. DURING THE PRIMARY SURGERY IMPLANT INSERTION, A CRACK WAS CONFIRMED IN THE GREATER TUBERCLE. THE SURGEON COMMENTED THAT THE CRACK WAS A POSSIBLE CAUSE OTHER THAN THE PRODUCTS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Unspecified Tissue Injury

  MAUDE report 16796928 ↗
• InjuryApr 6, 2023Osseointegration Problem; Osseointegration Problem

  THE STEM WAS UNCEMENTED. IT WAS A POST FRACTURE . THE PRODUCT WAS REPLACED WITH A LONG 8MM STEM, EPI 1 CENT AND 38 +9 PE CUP. THE SURGEON WAS VERY HAPPY WITH THE REVISED OUTCOME. STEM HAD TO BE REMOVED AND REPLACED DUE TO LOOSENING.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 16688763 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2016. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 16322175 ↗
• MalfunctionJan 20, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING PRIMARY PROCEDURE, THE SURGEON WAS ASSEMBLING THE IMPLANTS WHEN HE COULD NOT ASSEMBLE STEM TO EPI. HE INDICATED THAT THE INSERTION AREA ON STEM WAS TOO SMALL TO ACCEPT EPI. NEW STEM WAS OPENED AND NO ISSUE. THERE WAS A SURGICAL DELAY OF 15 MINS. DOI: UNKNOWN, DOR: UNKNOWN, AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16214334 ↗
• MalfunctionNov 22, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT REPORTED SHE HAD MULTIPLE DOCTORS REVIEW X-RAYS AND THAT THEY SAID THE ITEM WAS TOO LARGE AND SITTING PROUD OR TOO HIGH. SHE HAS SINCE HAD ISSUES WITH THE SURGERY AND EXPERIENCED PAIN. DOI: (B)(6) 2022. RIGHT SHOULDER.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 15843008 ↗
• MalfunctionNov 21, 2021Difficult to Insert; Difficult to Insert

  DURING THE PROCEDURE, THE SURGEON NOTICED THAT MATING THE EPIPHYSIS TO THE STEM SEEMED MORE DIFFICULT THAN USUAL AND TRIED TWO DIFFERENT COMBINATIONS. HE SUCCESSFULLY IMPACTED ONE EPIPHYSIS TO A STEM AND ENGAGED THE ATTACHING SCREW SUCCESSFULLY IMPLANTING BOTH PIECES AND COMPLETING THE SURGERY. NO ADVERSE EVENTS OCCURRED BESIDE A 3-5 MINUTE DELAY WHEN RETRIEVING THE OTHER IMPLANTS AND THE SURGEON MANUALLY SOLVING THE ISSUE. DOE: (B)(6) 2021.

  Patient problems: Insufficient Information

  MAUDE report 12850061 ↗
• MalfunctionNov 21, 2021Difficult to Insert; Difficult to Insert

  DURING THE PROCEDURE, THE SURGEON NOTICED THAT MATING THE EPIPHYSIS TO THE STEM SEEMED MORE DIFFICULT THAN USUAL AND TRIED TWO DIFFERENT COMBINATIONS. HE SUCCESSFULLY IMPACTED ONE EPIPHYSIS TO A STEM AND ENGAGED THE ATTACHING SCREW SUCCESSFULLY IMPLANTING BOTH PIECES AND COMPLETING THE SURGERY. NO ADVERSE EVENTS OCCURRED BESIDE A 3-5 MINUTE DELAY WHEN RETRIEVING THE OTHER IMPLANTS AND THE SURGEON MANUALLY SOLVING THE ISSUE. DOE: (B)(6) 2021.

  Patient problems: Insufficient Information

  MAUDE report 12850055 ↗
• MalfunctionSep 24, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SIZE 1 EPIPHYSIS CENTERED WOULD NOT FIT INTO THE STEM. DOI: UNK. DOR: (B)(6) 2021. UNK KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12526143 ↗
• MalfunctionAug 24, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT TWO IMPLANTS WERE OPENED AND WERE FOUND TO HAVE A DEFECTIVE PROBLEM WITH PUTTING THEM TOGETHER. THE EPI STEM WOULD NOT FIT INTO THE OPENING ON THE UNITE STEM. MINIMAL SURGICAL TIME WAS WASTED AND THE PROBLEM IMPLANTS WERE NEVER INTRODUCED TO THE PATIENT. THERE WAS NO IMPLANT/EXPLANT AS THE PROBLEM WAS DETECTED EARLY AND ALL PARTS WERE RETRIEVED FOR RETURN.

  Patient problems: Insufficient Information

  MAUDE report 12358432 ↗
• InjuryApr 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT SHOULDER.

  Patient problems: Pain

  MAUDE report 11613696 ↗
• InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS HUMERAL FRACTURE DUE TO FALL AND LOOSENING OF THE HUMERAL STEM AT THE BONE TO IMPLANT INTERFACE. THE PATIENT HAD A DELTA EXTEND REVERSE SHOULDER IMPLANTED YEARS AGO. THE HUMERAL COMPONENTS WERE REVISED AND THE METAGLENE, SCREWS AND GLENOSPHERE WERE LEFT IMPLANTED. AN 8MM UNITE REVISION STEM, SIZE 1 CENTERED EPI, 2 SPACERS AND A 42MM + 3 POLY WERE IMPLANTED. DOI: (B)(6) 2017, DOR: (B)(6) 2020, LEFT SHOULDER.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 11118065 ↗
• InjuryNov 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PT UNDERWENT PRIMARY TOTAL SHOULDER REPLACEMENT IN (B)(6) 2016. HISTORY OF INFECTED PROSTHETIC JOINT. SURGEON WHO PERFORMED PRIMARY SURGERY ATTEMPTED REMOVAL OF PROSTHESIS (DATE UNKNOWN). ONLY PROSTHETIC HEAD WAS REMOVED AS STEM WAS TOO WELL FIXED, AND UNABLE TO BE REMOVED. REVISION SURGEON REMOVED HUMERAL STEM, MULTIPLE SPECIMENS COLLECTED. COMPETITOR PROSTHESIS IMPLANTED, USING CUSTOM GLENOID PROSTHESIS AS WELL.

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

  MAUDE report 10919516 ↗
• InjuryJul 20, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS PERI PROSTHETIC FRACTURE AND LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2015, DOR: (B)(6) 2020, LEFT SHOULDER.

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

  MAUDE report 10299163 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PERI PROSTHETIC FRACTURE. DOI: (B)(6) 2016, DOR: (B)(6) 2020, RIGHT SHOULDER.

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

  MAUDE report 10192083 ↗
• InjuryJun 18, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS PAIN. ALL COMPONENTS WERE REMOVED AND CONVERTED TO A NON-DEPUY REVERSE TOTAL SHOULDER. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2018. DOR: (B)(6) 2020, LEFT SHOULDER.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 10167268 ↗
• MalfunctionMay 28, 2020Device-Device Incompatibility; Device-Device Incompatibility

  INTRAOPERATIVELY THE CENTRIC EPIPHYSIS SZ. 1 DID NOT FIT INTO THE STEM. ANOTHER STEM WAS USED AND CONNECTED WITH THE EPIPHYSIS WITHOUT ISSUES. SURGICAL DELAY < 15 MINUTES, NO ADVERSE CONSEQUENCES FOR PATIENT.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 10098170 ↗
• InjuryDec 26, 2019Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  DUE TO STEM NOT SEATING CORRECTLY WHEN IMPLANTED, BELIEVED TO BE DUE TO CANCER TREATMENT AT THE SAME TIME CONSISTING OF CHEMO AND RADIATION. DEPUYS SYNTHES PRODUCTS WERE REMOVED WHICH INCLUDED THE STEM, CTA HEAD AND EPIPHYSIS AS PER ABOVE. LIMA CUSTOM MADE TOTAL SHOULDER WAS IMPLANTED.

  Patient problems: No Code Available

  MAUDE report 9519900 ↗
• 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 9426031 ↗
• InjuryMay 2, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE HUMERAL STEM AT CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. LOOSE SHOULDER PROSTHESIS. NO ADDITIONAL INFORMATION. DOI: UNKNOWN, DOR: (B)(6) 2019, LEFT SHOULDER.

  Patient problems: No Code Available

  MAUDE report 8573498 ↗
• InjuryJun 19, 2018Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE HUMERAL STEM AT BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. IT ALSO REPORTED THAT IT WAS REVISED TO A LONG CEMENTED STEM. DOI: (B)(6) 2017; DOR: (B)(6) 2018; RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration; Not Applicable

  MAUDE report 7613362 ↗
• InjuryApr 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2017; DOR: (B)(6) 2018, RIGHT SHOULDER.

  Patient problems: Not Applicable; Pain

  MAUDE report 7450246 ↗
• InjuryApr 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS SUSPECTED INFECTION. EXPLANATION WITH PLACEMENT OF ANTIBIOTIC SPACER. DOR: (B)(6) 2017. DOR: (B)(6) 2018; RIGHT SHOULDER.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7424608 ↗

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-0485-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
• Z-0486-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
• 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-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