GLOBAL UNITE 1100-40-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10603295004417), received between Dec 8, 2017 and Sep 30, 2026 — classified as 28 injuries.

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

9 other recalls cover devices cleared under the same FDA submission (K133834, 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient had left anatomic total shoulder approximately 10 years ago. Original date of surgery and hospital are unknown. Patient developed rotator cuff arthropathy and was revised to a reverse total shoulder.DOI: Unknown. DOR: (b)(6) 2026.Affected side: Left shoulder.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50944799 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ANATOMIC TO REVERSE REVISION NOT DUE TO IMPLANT FAILURE BUT TO ROTATOR CUFF WEAR. NO FURTHER INFORMATION KNOWN AT THIS TIME. PRODUCT LOTS ARE UNTRACEABLE THROUGH OPTIMIZE DUE TO LACK OF PRIOR CASE DGR. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24389112 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SHOULDER REVISION DUE TO A FRACTURE. EXTRACTION OF DEPUY IMPLANTS. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Bone Fracture(s)

  MAUDE report 24010903 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT TORE ROTATOR CUFF AND NEEDED TO BE CONVERTED TO A REVERSE - ANOTHER SYSTEM WAS USED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24010458 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE DUE TO A CUFF TEAR, DURING WHICH ALL COMPONENTS EXCEPT THE STEM WERE REMOVED AND THE CASE WAS CONVERTED FROM AN ANATOMIC SHOULDER TO A REVERSE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23688458 ↗
• 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 23330315 ↗
• InjuryAug 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  GLOBAL ANATOMIC IMPLANTED ON [DATE] ONTO [PATIENT] BY [SURGEON]. HEAD DISLODGED FROM PROXIMAL BODY WHILST PATIENT WAS IN BED. GLOBAL UNITE ANATOMIC ANCHOR PEG GLENOID, GLOBAL UNITE HEAD, AND GLOBAL UNITE ANATOMIC PROXIMAL BODY REMOVED. REPLACED WITH DELTA X-TEND REVERSE IMPLANTS. SIGNIFICANT METALLOSIS IN PATIENT AND IMPLANTS WILL BE CLEANED BY THE HOSPITAL TO BE SENT FOR INVESTIGATION. PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? METALLOSIS, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: NO, (B)(6). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(6). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(6). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: Foreign Body Reaction

  MAUDE report 22715266 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT UNITE PROXIMAL BODY, HEAD, AND ANCHOR PEG GLENOID WERE REMOVED TO CONVERT TO A REVERSE TOTAL SHOULDER BECAUSE OF SUBSCAPULARIS DEFICIENCY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22608632 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CONVERSION TO REVERSE SHOULDER DUE TO ROTATOR CUFF FAILURE. NO IMPLANT LOOSENING OR FAILURE. DOI: (B)(6) 2017 DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21892211 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SUBSCAP FAILURE. IT WAS CONVERTED TO REVERSE KEPT DISTAL STEM. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20800424 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WAS THERE ANY SURGICAL DELAY? NO ADDITIONAL TIME.

  Patient problems: Joint Laxity

  MAUDE report 18950384 ↗
• 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 17747122 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR PAIN. EXPLANTED THE PROXIMAL BODY OF THE GLOBAL UNITE STEM, THE GLOBAL HEAD AND ANCHOR PEG GLENOID. DOI: (B)(6) 2022. DOE:. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 17649985 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS TORN THEIR ROTATOR CUFF. WE CONVERTED TO A REVERSE. THERE WAS NO SURGICAL DELAY. DOI: (B)(4) 2022; DOR: (B)(4) 2023; AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16993654 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ANATOMIC SHOULDER REPLACEMENT AT (B)(6) HOSPITAL (B)(6) IN (B)(6) 2022, UNSURE OF THE DATES. SHE PRESENTED WITH ROTATOR CUFF FAILURE AND REQUIRED CONVERSION FROM GLOBAL UNITE ANATOMIC TO DELTA XTEND REVERSE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16642953 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN IN SHOULDER REGION AFTER SHOULDER REPLACEMENT; CHRONIC PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2020. DATE OF EVENT: (B)(6) 2020. (RIGHT SHOULDER). TREATMENT: INITIAL WORK UP FOR INFECTION WITH BLOOD WORK.

  Patient problems: Loss of Range of Motion; Nerve Damage; Numbness; Pain; Paresthesia; Unspecified Infection

  MAUDE report 15951597 ↗
• InjurySep 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON TOLD SALES REP IN THE AM ON (B)(6) 2022 HE WAS REVISING A PATIENT HEMI ARTHROPLASTY THAT AFTERNOON AND ASKED HIM TO LOOK AT X-RAYS. HE TOLD HIM IT APPEARED TO BE A UNITE STEM CONSTRUCT AND THAT HE WOULD BE ABLE TO CONVERT TO A REVERSE CONSTRUCT IF HE WOULD LIKE. SURGEON WAS REVISING THIS CONSTRUCT BECAUSE OF CUFF DEFICIENCY WHICH WAS CAUSING LACK OF ROM AND PAIN. HE EXPLANTED THE UNITE PROXIMAL BODY, THE HUMERAL HEAD AND CONVERTED THE CONSTRUCT TO A REVERSE SHOULDER. THE UNITE STEM WAS LEFT IN SITU. THE ORIGINAL DATE OF SURGERY AND WHO DID THE SURGERY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Loss of Range of Motion; Pain; Unspecified Tissue Injury

  MAUDE report 15494824 ↗
• InjuryJun 16, 2022Adverse 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 INSTABILITY. NO SURGICAL DELAY. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 14714729 ↗
• InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 12229370 ↗
• InjuryJun 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND ROTATOR CUFF DEFICIENCY. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2020. DOR: (B)(6) 2021. LEFT SHOULDER.

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

  MAUDE report 11960002 ↗
• InjuryApr 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S SHOULDER WAS REVISED DUE TO TUBEROSITY FRACTURED OFF. DOI: (B)(6) 2020, DOR: (B)(6) 2021, RIGHT SHOULDER.

  Patient problems: Bone Fracture(s)

  MAUDE report 11628391 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AND REVIEWED: IT IS NOTED THE DATE OF LEFT SHOULDER MANIPULATION UNDER ANESTHESIA OCCURRED ON (B)(6) 2020. IN ADDITION TO THE PREVIOUSLY REPORTED ISSUES, THE PATIENT WAS ALSO EXPERIENCING THE FOLLOWING ADVERSE SYMPTOMS PRIOR TO LEFT SHOULDER MANIPULATION UNDER ANESTHESIA ON (B)(6) 2020: PAIN, DISCOMFORT, DECREASED RANGE OF MOTION, AND WEAKNESS. EVALUATION NOTES FOLLOWING THE LEFT SHOULDER MANIPULATION REVEALED IMPROVING SYMPTOMS.

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

  MAUDE report 11176063 ↗
• InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN DUE TO INFECTION. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT SHOULDER.

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

  MAUDE report 10905890 ↗
• 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 10809833 ↗
• 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 10289976 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133834, K170748. One submission often covers many models, so check the product and lot details in each record.

• 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-0484-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
• 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
• Z-0489-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
• Z-0488-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
• Z-0483-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
• Z-1012-2018 · Nov 28, 2017 · Terminated
  The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling: LEO-1100-30-000 REV D.pd