GLOBAL AP 1130-12-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295005544), received between Aug 7, 2018 and Feb 3, 2025 — classified as 8 injuries.

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

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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: 1. CAN YOU PLEASE ADVISE ON THE SURGEON¿S OPINION FOR THE REASON OF THE REVISION SURGERY? FAILED ROTATOR CUFF. 2. WAS IT RELATED TO PATIENT FACTORS OR DEVICE RELATED? PATIENT. 4. PLEASE CONFIRM IF ALL BELOW COMPONENTS WERE EXPLANTED ? AND DISCARDED? EXPLANTED AND LEFT AT HOSPITAL. 5. WAS THERE ANY ALLEGATION AGAINST THE METAGLENE GUIDE PIN DIA 2.5MM? N/A.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21292749 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. IMPLANTS WERE EXPLANTED AND A CEMENT SPACER WAS PUT IN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2015. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 16853894 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT TOTAL SHOULDER REMOVED FOR PROSTALAC SPACER BECAUSE OF INFECTION. IMPLANTED APPROXIMATELY 10 YEARS AGO. NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 12468700 ↗
• InjuryMar 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE IS LOGGED TO CAPTURE THE REVISION MENTIONED IN (B)(4). THE BASE OF THE HANDLE OF THE STEM INSERTER BECAME LOOSE, ALLOWING IT TO SLIDE DOWN THE SHAFT OF THE INSERTER, AFTER THE SURGEON HAMMERED IT (IN THE CORRECT LOCATION) IN AN ATTEMPT TO REMOVE A STEM. THIS OCCURRED DURING A REVISION CASE WHERE A GLOBAL AP WAS BEING REMOVED. THE SURGEON WAS ABLE TO USE OTHER INSTRUMENTS WITHIN OUR SHOULDER EXTRACTION TRAYS TO SUCCESSFULLY REMOVE THE STEM AND COMPLETE THE OPERATION SUCCESSFULLY. THE REVISION WAS DUE TO THE PATIENT EXPERIENCING STIFFNESS DUE TO ARTHROFIBROSIS WITH A SMALL DEGREE OF CUFF DAMAGE. THE CAUSE OF THE REVISION DID NOT HAVE ANYTHING TO DO WITH THE IMPLANTS THEMSELVES RIGHT SHOULDER.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Muscular Rigidity

  MAUDE report 11528223 ↗
• InjurySep 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY ANATOMIC SHOULDER REPLACEMENT ON (B)(6) 2014. LAST 2 YEARS, INCREASING STIFFNESS IN SHOULDER JOINT, WITH MODERATE DEGREE OF DISCOMFORT. CURRENTLY UNABLE TO ABDUCT ARM PAST LEVEL OF SHOULDER. SURGEON STATED GLENOID WAS A B2 GLENOID AT THIS SURGERY. ALL COMPONENTS WELL FIXED, NO EVIDENCE OF INFECTION AND WITH CONCENTRIC WEAR ON GLENOID POLY COMPONENT. ALL COMPONENTS REMOVED (HUMERAL EPISIOTOMY REQUIRED); AND A COMPETITOR RSA PROSTHESIS (ZIMMER COMPREHENSIVE) IMPLANTED, USING AUGMENTED GLENOID COMPONENT.

  Patient problems: Discomfort; Limited Mobility Of The Implanted Joint; Muscular Rigidity; No Code Available; Pain

  MAUDE report 10528771 ↗
• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PERI-PROSTHETIC FRACTURE OF HER HUMERUS BELOW THE CURRENT STEM DUE TO FALL. THE FRACTURE WAS REDUCED, REPAIRED VIA CABLES, HUMERAL PLATE, AND A GLOBAL UNITE LONG STEM. ALL PREVIOUS IMPLANTS WERE REMOVED IN ORDER TO FIXATE THE FRACTURE PROPERLY. THE PATIENT UNDERWENT A GLOBAL AP CTA HEAD HEMI CONSTRUCT IN 2017. DOI: (B)(6) 2017. DOR: (B)(6) 2019. RIGHT SHOULDER.

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

  MAUDE report 9376281 ↗
• InjuryAug 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL SHOULDER. DOI: UNK; DOR: (B)(6) 2018; UNKNOWN SHOULDER.

  Patient problems: Not Applicable; Pain

  MAUDE report 7767541 ↗
• InjuryAug 7, 2018Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE SURGEON REMOVED GLOBAL UNITE IMPLANTS DUE TO MALPOSITIONED COMPONENTS AND WORN GLENOID. SURGEON CHOOSE TO IMPLANT A REVERSE SHOULDER CONSTRUCT. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT SHOULDER.

  Patient problems: Not Applicable

  MAUDE report 7756609 ↗