GLOBAL AP 1130-02-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10603295005438), received between Nov 8, 2017 and Mar 31, 2026 — classified as 27 injuries, 1 malfunction.

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

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.

• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR CONCERN FOR GLENOID COMPONENT LOOSENING/POLY WEAR RESULTING IN PAIN AND DYSFUNCTION IN RIGHT SHOULDER. DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: PROBABLE, PROCEDURE RELATED: PROBABLE, DATE OF EVENT: 1 JAN 2026, DATE OF IMPLANT: ON (B)(6) 2013, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT SHOULDER. TREATMENT/IMPACT: ASPIRATION: YES. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 113643026. LOT NUMBER: 348444. COMPONENT TYPE: ANCHOR. DESCRIPTION: PREMIERON XLINKED GLENOID ANCHOR PEG 52MM. CATALOG NUMBER: 113014000. LOT NUMBER: 351106. COMPONENT TYPE: STEM. DESCRIPTION: GLOBAL HUMERAL STEM SZ 14. CATALOG NUMBER: 110052520. LOT NUMBER: FK1JD1. COMPONENT TYPE: HEAD. DESCRIPTION: GLOBAL UNITE HEAD 52X21 STD. CATALOG NUMBER: 113002000. LOT NUMBER: 371961. COMPONENT TYPE: TAPER ASSEMBLY. DESCRIPTION: GLOBAL AP TAPER ASSEMBLY 135 DEGREE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 24743641 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION FROM A GLOBAL AP TO A DELTA EXTEND DUE TO CUFF TEAR AND SUPERIOR MIGRATION OF THE HUMERUS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23512094 ↗
• 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 21292622 ↗
• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT STARTED HAVING TROUBLE WITH ELEVATION, WEAKNESS AND PAIN. NO SPECIFIC INJURY. IMPLANTS WERE IN GOOD CONDITION WITH NO ISSUES. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Fatigue; Loss of Range of Motion; Pain

  MAUDE report 21027942 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF LEFT SHOULDER HEMI ARTHROPLASTY -PATIENT EXPERIENCING PAIN, PLAN TO REVISE TO A TOTAL SHOULDER (ADD GLENOID COMPONENT AND REPLACE HEAD AND TAPER), BUT SURGEON FOUND HEAD WAS SITTING TOO HIGH, SO REMOVED STEM AND REPLACED WITH A NEW STEM, SINKING IT TO A BETTER POSITION . ORIGINAL SURGERY 2 OR SO YEARS AGO - EXACT DATE WAS NOT AVAILABLE. DOE: 26-FEB-2024.

  Patient problems: Pain

  MAUDE report 18836366 ↗
• 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 16853892 ↗
• InjuryNov 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SHOULDER PAIN. SURGEON DETERMINED THE SHOULDER HAD SOME SORT OF INFECTION THAT REQUIRED IT TO BE WASHED OUT. WHILE THE SURGEON WAS IN THE JOINT SURGEON DECIDED IT BEST TO REMOVE THE TAPER AND HEAD SO HE COULD REPLACE THEM. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME. DOI: (B)(6) 2021. DOR: (B)(6) 2021. LEFT SHOULDER.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 12729044 ↗
• 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 12468699 ↗
• InjuryAug 12, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SURGEON ELECTED TO PERFORM A LEFT SHOULDER REVISION ARTHROPLASTY ON A PATIENT WHO HE PERFORMED A PRIMARY TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2010. SURGEON NOTED THAT THE PATIENT PERFORMED WELL POST OPERATIVELY AFTER HER PRIMARY SHOULDER ARTHROPLASTY UNTIL 2018 WHEN SHE EXPERIENCE SEVERAL DISLOCATIONS. SURGEON DID NOT SPECIFY THE EXACT NUMBER OF DISLOCATIONS OF THE LEFT SHOULDER. MOST RECENT DISLOCATION HAPPENED ON (B)(6) 2021 AND DOCTOR NOTED THEY HAD DIFFICULTY REDUCING THE PATIENT¿S SHOULDER THIS TIME BUT WERE SUCCESSFUL IN REDUCING IT. AFTERWARDS HE SAW THE PATIENT IN CLINIC AND TOOK FILMS WHICH SHOWED A SEPARATION OF THE HUMERAL IMPLANT AT THE 135 DEGREE TAPERED NECK SPACER AND THE HUMERAL STEM. THE TAPERED SPACER AND HUMERAL HEAD CONSTRUCT REMAINED INTACT. DOCTOR THEN ELECTED TO REVISE THE PATIENT¿S SHOULDER DUE TO THE SEPARATION ON WEDNESDAY, (B)(6) 2021 AT (B)(6) HOSPITAL. UPON EXPOSURE TO THE LEFT SHOULDER CUFF SURGEON FELT THE CUFF WAS COMPROMISED SEVERELY ENOUGH TO WARRANT A REVERSE SHOULDER REPLACEMENT THUS REQUIRING ALL PRIMARY COMPONENTS TO BE REVISED. DOCTOR WAS ABLE TO REMOVE THE TAPERED NECK SPACER AND HUMERAL HEAD CONSTRUCT WITH HIS HAND. HE THEN USED OSTEOTOMES,

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

  MAUDE report 12317071 ↗
• 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 11528217 ↗
• InjuryFeb 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WITH GLOBAL AP (WITH ANCHOR PEG GLENOID) IMPLANTED IN 2012 WAS REVISED DUE TO INFECTION. IMPLANTS WERE REMOVED AND AN ANTIBIOTIC IMPREGNATED SPACER IMPLANTED.

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

  MAUDE report 11378695 ↗
• InjuryJan 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PT IS BEING REVISED FOR CHRONIC PAIN AND STIFFNESS.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 11247526 ↗
• InjuryDec 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A PARTIAL REVISION RIGHT SHOULDER REPLACEMENT. THE GLENOID COMPONENT WAS REMOVED AND THE NECK TAPER AND HEAD WAS CHANGED.

  Patient problems: Pain

  MAUDE report 10985083 ↗
• InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE AFFECTED SIDE IS LEFT. INFECTION WAS NOT CONFIRMED.

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

  MAUDE report 10900799 ↗
• 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 10528772 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL SHOULDER. SURGEON EXPLANTED GLOBAL AP HUMERAL HEAD, TAPER ASSEMBLY AND APG GLENOID. REVISED WITH CTA HEAD. DOI: (B)(6) 2010, DOR: (B)(6) 2020, RIGHT SHOULDER.

  Patient problems: No Code Available; Pain

  MAUDE report 10258743 ↗
• InjuryJul 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENT IN THE DOCTOR'S OFFICE WITH A PAINFUL LEFT SHOULDER AND A DECREASE IN RANGE OF MOTION. SURGEON ORDERED A SERIES OF STUDIES AND FORMED THE OPINION THAT THE INDEX GLENOID COMPONENT WAS LOOSE. THE SURGEON REVISED THE SHOULDER. UPON EXPOSURE TO THE JOINT SPACE, DR. REMOVED THE 52X18 STANDARD HUMERAL HEAD FOR THE AP SHOULD SYSTEM, AND THE 135 TAPERED SPACER WITH THE STANDARD HEAD REMOVAL FORK IN THE GLOBAL AP TRAYS. THE SIZE 10 GLOBAL AP STANDARD STEM WAS KEPT IMPLANTED. SURGEON THEN EASILY REMOVED THE 52 ANCHOR PEG GLENOID WITH A PAIR OF KOCHERS. DUE TO BONE LOSS, SURGEON THEN IMPLANTED A COMPETITIVE GLENOID. NO INSTRUMENTATION BROKE DURING SURGERY AND THERE WERE NO DELAYS.

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

  MAUDE report 10240906 ↗
• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD THEIR INDEX HEMI REVISED TO AN A TOTAL SHOULDER ARTHROPLASTY FOR PAIN. HEAD AND TAPE REMOVED; APG+ IMPLANTED ALONG WITH NEW HEAD AND 135 DEGREE TAPER. DOI: (B)(6) 2020; DOR: (B)(6) 2020; UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 9938872 ↗
• InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ATSR: (B)(6) 2019. THE PATIENT HAD A RIGHT GLOBAL AP AND ANCHOR PEG GLENOID ATSR ON (B)(6) 2019. PT HAD NORMAL POST-OP RECOVERY AND EARLY REHAB. POST-OP TRAUMA WITH SIGNIFICANT FALL 1-MONTH POST-OP. PAINFUL SINCE. NO FRACTURES OR OBVIOUS DISRUPTION OF COMPONENTS. GOOD RANGE OF MOVEMENT, BUT THE PAIN PERSISTED. INVESTIGATED FOR INFECTION, SOME P ACNE? SCANNED AND HOT SPOTS BOTH GLENOID AND PROXIMAL HUMERUS. THE ARTHROSCOPIC INVESTIGATION, ?LOOSE. REVISED TO DELTA XTEND RTSR TODAY. ANCHOR PEG GLENOID COMPONENT HAD NO EVIDENCE OF OSSEOINTEGRATION AND WAS RELATIVELY EASY TO REMOVE. GLOBAL AP COMPONENTS APPEARED WELL FIXED. NORMAL POST-OP RECOVERY EXPECTED. NO AE REPORTED, NO DELAY IN THE SURGERY. MALE PATIENT, INITIALS: (B)(6), ACTIVE AND HEALTHY PT, RELEVANT PATIENT PRE-EXISTING CONDITIONS: PREVIOUS GLOBAL AP AND ANCHOR PEG GLENOID ATSR LEFT SIDE, FUNCTIONING WELL. X-RAY AND CT ARE AVAILABLE.

  Patient problems: Fall; Pain; Unspecified Infection

  MAUDE report 9460078 ↗
• InjuryNov 30, 2018Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available; Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISED DUE TO PAIN AND LOOSENING.

  Patient problems: Not Applicable; Pain

  MAUDE report 8119445 ↗
• 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 7767579 ↗
• 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 7613439 ↗
• InjuryApr 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A PAINFUL AND STIFF RIGHT TOTAL SHOULDER. ORIGINAL DATE OF SURGERY (B)(6) 2014. PATIENT CONSEQUENCE?: YES. PATIENT CONSEQUENCE DESCRIPTION: PATIENT NEEDED REVISION SURGERY ACTION TAKEN FOR PROCEDURE: PATIENT WAS REVISED TO A SMALLER HUMERAL HEAD IMPLANT IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES.

  Patient problems: Not Applicable; Pain

  MAUDE report 7446258 ↗
• 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 7355145 ↗
• MalfunctionMar 6, 2018Connection Problem; Positioning Problem; Connection Problem; Positioning Problem

  DER STATES THAT THE GLOBAL AP STEM WAS ASSEMBLED USING THE FIX 135 NECK ANGLE. THE SURGEON NOTICED AFTER IT WAS IMPLANTED THAT THE HEAD SAT PROUD . IT WAS REMOVED AND DISASSEMBLED. USING THE SAME STEM THEY CONVERTED IT TO A VARIABLE ANGLE AND THE WAS PREPARED AS PER TECHNIQUE BUT DID NOT MATCH THE TRIAL IMPLANT. THE SIZE 10 STEM WAS REPLACED WITH THE NEW STEM AND USED THE VARIABLE ANGLE AGAIN. THERE WAS A SURGICAL DELAY OF 20 MINUTES. DOE: (B)(6) 2018 RIGHT SHOULDER.

  Patient problems: Not Applicable

  MAUDE report 7315956 ↗