GLOBAL UNITE 1100-14-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295004158), received between Sep 25, 2018 and Dec 16, 2025 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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-0489-2022 · Root cause: Equipment maintenance · Recall details · FDA record ↗

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.

• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL IMPLANTS WERE REMOVED DUE TO INFECTION. AFFECTED SIDE- RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 23818630 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WASHOUT WAS PERFORMED FOR INFECTION. ALL IMPLANTS WERE REMOVED. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22336938 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT PATIENT WAS REVISED, DUE INFECTION. IMPLANT WAS REMOVED. DOI: (B)(6) 2023; DOR: (B)(6) 2024; AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 20054632 ↗
• 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 19689526 ↗
• 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 18857368 ↗
• InjuryDec 27, 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: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 18397832 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SHOULDER INFECTION AND SURGEON REMOVED HARDWARE, IRRIGATED AND IMPLANTED A SPACER.DOR: (B)(6) 2023. AFFECTED SIDE : RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 16859785 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION AND LOOSENING OF THE METAGLENE AT THE BONE TO IMPLANT INTERFACE. ALL IMPLANTS WERE REMOVED AND PLACEMENT OF SPACER WAS PERFORMED. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 16254916 ↗
• InjuryDec 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO PAIN AND STIFFNESS. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: (B)(6) 2022. (RIGHT SHOULDER). TREATMENT: CUP, GLENOSPHERE, AND EPIPHYSIS WERE REVISED.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 15995937 ↗
• InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS INFECTED. ALL IMPLANTS REMOVED. NO SURGICAL DELAY REPORTED. NO REPORTED LOOSENING. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 14345838 ↗
• 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 9738407 ↗
• MalfunctionApr 8, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ETCH MARK IN THE EPI 1 DID NOT LINE UP WITH THE 0 MARK WHEN ASSEMBLING THE STEM AND EPI. 1 MINUTE SURGICAL DELAY. DOE: (B)(6) 2019, RIGHT SHOULDER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8491029 ↗
• InjurySep 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT HUMERAL HEMI-ARTHROPLASTY, DR (B)(6), (B)(6) HOSPITAL (B)(6) 2018. PRIMARY IMPLANTATION - LEFT SHOULDER HEMI-ARTHROPLASTY ABOUT 2 YEARS AGO IN (B)(6) BY DR. (B)(6). THE SHOULDER WAS INFECTED AND SOME TESTS WERE DONE AND DR. (B)(6) FOUND OUT THAT THE PATIENT HAD A PSEUDOMONAS INFECTION IN HIS LEFT SHOULDER. THE SKIN WAS RED, SLIGHTLY EDEMATOUS AND INFLAMED. AFTER SKIN INCISION, IT WAS IMMEDIATELY NOTICEABLE THAT THERE WAS PUS COMING OUT. MULTIPLE SWABS AND CULTURE SPECIMEN WERE TAKEN WHILE DR. (B)(6) OPENED UP INTO THE JOINT. ONCE IN THE SHOULDER JOINT, DR. (B)(6) USED THE TUNING FORK TO REMOVE THE HUMERAL HEAD AND THE SUTURE COLLAR, AND THEN HE USED THE BIG VICE GRIP FORCEPS AND SLAP HAMMER TO TAKE THE STEM AND PROXIMAL BODY OUT. HE PUT IN A ZIMMER SPACER WITH ANTIBIOTIC CEMENT, COMPOUNDED BY SOME MORE ANTIBIOTIC AND CLOSED UP THE JOINT. HIS PLAN IS TO REMOVE THE SPACER ONCE THE INFECTION HAS SUBSIDED AND TO PUT A DELTA XTEND IN. MALE PATIENT (B)(6).

  Patient problems: Unspecified Infection

  MAUDE report 7905244 ↗

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-0487-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
• 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-0484-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
• Z-0485-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
• 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