GLOBAL UNITE 1100-44-600Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295004547), received between Oct 20, 2017 and Jul 28, 2026 — classified as 21 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 reports).

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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient has a failed subscap. Surgeon exchanged head and did a repair.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Right shoulder.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50061504 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO SUBSCAP FAILURE CONVERTED FROM A TOTAL SHOULDER TO REVERSE, KEEPING THE DISTAL STEM IN PLACE. AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25334726 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A SHOULDER HEMIARTHROPLASTY (B)(6) 2017. RECENTLY COMPLAINING OF SHOULDER PAIN-ROTATOR CUFF INSTABILITY FOUND ON MRI. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity; Pain; Unspecified Tissue Injury

  MAUDE report 22157830 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CONVERSION OF AN ANATOMIC SHOULDER WAS REQUIRED DUE TO ROTATOR CUFF LIGAMENTS BEING WORN. THERE WAS NO SURGICAL DELAY. AFFECTED AREA: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21976282 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20205367 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A CUFF TEAR. SURGEON CONVERTED FROM A TSA TO A REVERSE SHOULDER. SURGICAL DELAY UNKNOWN. ACTIVITY LEVEL - YES. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18442531 ↗
• InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD CONVERSION FROM HEMI TO TOTAL SHOULDER DUE TO PAIN. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 16931063 ↗
• InjuryNov 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use 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

  MAUDE report 15749049 ↗
• InjuryNov 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATING THAT THEY CANNOT CONFIRM WHAT CEMENT WAS USED. SIMPLEX IS MOST COMMONLY USED ON THE GLENOID. THE ROTATOR CUFF FAILURE WAS DUE TO NATURAL PROGRESSION. AFFECTED SIDE: LEFT SIDE.

  Patient problems: No Code Available

  MAUDE report 10809835 ↗
• InjuryJul 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROX. 2 YEARS POST TSA. ELDERLY PATIENT WITH SIGNIFICANT CO-MORBIDITIES (ACCORDING TO SURGEON), WITH OSTEOPOROTIC BONE. PATIENT PRESENTED WITH PAIN AND DECREASED RANGE OF MOTION 6 MONTHS AGO. CT SCAN SHOWED LOOSENING OF GLENOID COMPONENT - SURGEON HAD USED BONE GRAFT AROUND CENTRAL PEG OF GLENOID COMPONENT, CEMENTED PERIPHERAL PEGS. GLOBAL UNITE HEAD AND PROXIMAL BODY REMOVED TO ACCESS GLENOID COMPONENT. GLENOID COMPONENT EASILY REMOVED. HEAD, PROXIMAL BODY AND APG+ GLENOID COMPONENT ALL SENT OFF FOR MICROSCOPY / CULTURE. MULTIPLE SOFT TISSUE SPECIMENS ALSO TAKEN. DISTAL UNITE STEM (REF. (B)(4)) AND BIOSTOP KEPT INSITU. REPLACEMENT APG+ GLENOID (44MM) IMPLANTED, CEMENT USED IN ALL PEGS. NEW UNITE PROXIMAL BODY AND HEAD - SAME SIZES AS REMOVED, ALSO IMPLANTED. SHOULDER STABLE ON REDUCTION.

  Patient problems: Limited Mobility Of The Implanted Joint; Loss of Range of Motion; No Code Available; Pain

  MAUDE report 10301736 ↗
• InjuryJul 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL SHOULDER. SURGEON EXPLANTED PROXIMAL UNITE BODY AND APG GLENOID, REVISING TO REVERSE. DOI: (B)(6) 2019 DOR: (B)(6) 2020 RIGHT SHOULDER.

  Patient problems: No Code Available; Pain

  MAUDE report 10289973 ↗
• InjurySep 11, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS FALL ABOUT 3 WEEKS AGO AND DISLOCATED SHOULDER. PATIENT HAD AN ANATOMIC TOTAL SHOULDER DONE ON (B)(6) 2019. SHOULDER COULDN'T BE REDUCED CLOSED SO THE PATIENT WAS BROUGHT TO SURGERY FOR CONVERSION TO A REVERSE TOTAL SHOULDER. DOI: (B)(6) 2019. DOR: (B)(6) 2019. RIGHT SHOULDER.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8992498 ↗
• InjuryMar 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN IN HER SHOULDER. PATIENT REQUESTED TO CONVERT FROM A LEFT HEMI SHOULDER TO A LEFT TOTAL SHOULDER. THE TEAM REMOVED THE EXISTING GLOBAL UNITE HUMERAL HEAD AND IMPLANTED A GLOBAL APG GLENOID WITH A NEW GLOBAL UNITE ECCENTRIC HUMERAL HEAD. DOI: (B)(6) 2017, DOR: (B)(6) 2019 LEFT SHOULDER.

  Patient problems: No Code Available; Pain

  MAUDE report 8429875 ↗
• InjuryJan 30, 2019Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT HAD NO CUFF LEFT SO IT WAS CONVERTED TO A REVERSE. SYMPTOMS THAT MAY HAVE LED TO CTA INCLUDE 60 DEGREE RETROVERSION AND LOW INSERTION OF STEM.

  Patient problems: No Code Available

  MAUDE report 8289642 ↗
• InjuryJun 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION OF SHOULDER ARTHROPLASTY ; DR. (B)(6); (B)(6) HOSPITAL (B)(6) 2018. PRIMARY IMPLANT DATE (B)(6) 2017. PATIENT COMPLAINED OF PAIN AND MILD INSTABILITY, 6 MONTHS HISTORY. SYNOVECTOMY, AND CHANGE OF HUMERAL HEAD CARRIED OUT. 40 X 15MM ECCENTRIC HEAD IMPLANTED. BOTH HUMERAL STEM AND GLENOID APG+ COMPONENTS WERE SOLIDLY STILL FIXED, LEFT ISSUE. MULTIPLE SPECIMENS TAKEN. PATIENT OUTCOME POST SURGERY: STABLE SHOULDER JOINT. FEMALE PATIENT INITIALS LT, DOB: (B)(6). X-RAYS UPLOADED TO UNITY.

  Patient problems: Not Applicable; Pain

  MAUDE report 7629128 ↗
• InjuryJun 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND TOTAL SHOULDER ARTHROPLASTY FAILURE. DOI: (B)(6) 2016; DOR: (B)(6) 2018; UNKNOWN AFFECTED SIDE.

  Patient problems: Pain

  MAUDE report 7613403 ↗
• InjuryJun 13, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS CHRONIC DISLOCATION AND LOOSENING OF THE STEM AND PROXIMAL BODY AT THE BONE TO IMPLANT INTERFACE. IT WAS ALSO STATED THAT THE SURGEON WAS CONCERNED ABOUT MALPOSITION OF THE STEM. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT SHOULDER.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7596450 ↗
• InjuryMar 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2013, DOR: (B)(6) 2018, LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 7355191 ↗
• InjuryMar 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. IT WAS ALSO INDICATED THAT THE SURGEON DECIDED TO UPSIZE THE HUMERAL HEAD. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 7355116 ↗
• InjuryDec 8, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7099444 ↗
• InjuryOct 20, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LITTLE MOBILITY. IT WAS ALSO INDICATED THAT THE PATIENT FELT LIKE THE SHOULDER JOINT WAS OVER-STUFFED WITH TOO LARGE A HUMERAL HEAD.

  Patient problems: No Code Available; Pain

  MAUDE report 6965768 ↗

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-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-0486-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
• Z-0485-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
• Z-0487-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
• Z-0490-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
• Z-0483-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610