GLOBAL UNITE 1100-52-620Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295004745), received between Feb 22, 2018 and Oct 17, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

8 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION AND ALL IMPLANTS WERE REMOVED AND NEW IMPLANTS WERE PUT IN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 23330324 ↗
• 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 17747215 ↗
• 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 15697587 ↗
• InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL SHOULDER AT (B)(6) HOSPITAL ON (B)(6) 2020. HE COMPLAINS OF SHOULDER JOINT PAIN AND INSTABILITY. SO HE WENT TO RUSH TO HAVE HIS SHOULDER REVISED BY THE SURGEON. ALSO, IT WAS REPORTED THAT THE GLENOID HAD LOOSENING AT THE BONE TO CEMENT INTERFACE. DEPUY CEMENT WAS USED. NO REPORT OF FALL OR ANY OTHER INCIDENT. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT SHOULDER.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11286314 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR STIFFNESS - S/P TSA : ARTHROFIBROSIS EVENT IS SERIOUS AND IS CONSIDERED MODERATE EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018. DATE OF EVENT (ONSET): (B)(6) 2020 (LEFT SHOULDER). TREATMENT: PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA, TRANSARTHROSCOPIC LYSIS OF ADHESIONS AND CAPSULAR RELEASE.

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

  MAUDE report 11176084 ↗
• 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 9738438 ↗
• InjuryJun 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. COMPONENTS WERE REMOVED AND ANTIBIOTIC SPACER WAS PLACED. THE STEPTECH GLENOID IMPLANT CURRENTLY REMAINS IN. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT SHOULDER.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8735083 ↗
• InjuryFeb 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION TSR, (B)(6) 2018. PATIENT COMPLAINING OF 12 MONTHS OF SHOULDER PAIN AS WELL AS LIMITED RANGE OF MOVEMENT. THE SURGEON WAS HAPPY TO DO A THOROUGH RELEASE AND WASHOUT OF THE SHOULDER AND DOWNSIZE THE HEAD FROM A 52X21 TO A 48X15. SURGEON HAPPY WITH ORIGINAL PROSTHESIS IMPLANTATION AND CITED NO ISSUES WITH ORIGINAL PROSTHESIS OR WITH ROTATOR CUFF, SO NO NEED TO REVERSE PROCEDURE. NO EVIDENCE OF INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2018; UNKNOWN SHOULDER.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 7288704 ↗

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-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-0486-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
• 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-0488-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100