GLOBAL AP 1130-12-000Recalls & reported problems
Depuy Orthopaedics, Inc. · GLOBAL AP STANDARD STEM SIZE 12 137mm · Class 2 · Implant
All models of GLOBAL AP (40)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295005520), received between Mar 19, 2018 and Feb 11, 2026 — classified as 5 injuries.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 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.
Reports received per month
Most reported problems
Device problems
- Loss of or Failure to Bond3
- Adverse Event Without Identified Device or Use Problem2
- Osseointegration Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Loss of Range of Motion2
- Inadequate Osseointegration1
- Insufficient Information1
- Joint Laxity1
- No Consequences Or Impact To Patient1
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN AND LACK OF FUNCTION. AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Joint Laxity; Loss of Range of Motion; Pain
MAUDE report 24313749 ↗InjuryJun 12, 2024Loss of or Failure to Bond; Loss of or Failure to Bond
REMOVAL OF ANATOMIC SHOULDER - REVISED TO REVERSE DUE TO DISEASE PROGRESSION AND LOOSENING. GLENOID COMPONENT DAMAGED.
Patient problems: Insufficient Information
MAUDE report 19522058 ↗InjuryApr 28, 2021Loss of or Failure to Bond; Osseointegration Problem; Loss of or Failure to Bond; Osseointegration Problem
ADDITIONAL INFORMATION RECEIVED STATED THE FOLLOWING: AS STATED IN THE EVENT, "HUMERAL STEM LOOSENING." CAN YOU PLEASE CONFIRM WHAT INTERFACE WAS LOOSE? THE IMPLANT-BONE INTERFACE WAS LOOSE. PLEASE CONFIRM IF THE CEMENT WAS MANUFACTURED BY DEPUY? IF YES, PLEASE PROVIDE THE QUANTITY, PART AND LOT NUMBERS OF THE CEMENT. THIS IS A CEMENTLESS IMPLANT. PLEASE ADVISE OF THE AFFECTED SIDE. RIGHT SIDE. PLEASE ADVISE IF THIS EVENT WAS DUE TO NATURAL PROGRESSION? THERE WERE MULTIPLE POTENTIAL FACTORS ATTRIBUTING TO THE REVISION: THERE IS GOOD EVIDENCE SHOWING THEY HEMI PROCEDURES ARE PRONE TO SIGNIFICANTLY HIGHER REVISION RATES THAN TOTAL REPLACEMENT. CUFF FAILURE LIMITING PATIENT ROM (MAY BE NATURAL PROGRESSION). GLENOID WEAR DUE TO METAL-BONE ARTICULATION. THIS IS A CEMENTLESS IMPLANT WITHOUT POROCOAT COATING WHICH DOESN¿T HAVE THE SAME SAME LEVEL OF FIXATION AS OUR CURRENT PRODUCT GLOBAL UNITE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inadequate Osseointegration; Loss of Range of Motion
MAUDE report 11737684 ↗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 11378699 ↗InjuryMar 19, 2018Loss of or Failure to Bond; Loss of or Failure to Bond
DR. (B)(6), TOTAL SHOULDER REPLACEMENT, (B)(6) HOSPITAL (B)(6) 2018. THE PRIMARY TSR TOOK PLACE APPROXIMATELY 10 YEARS AGO. SURGEON INDICATED THAT THE PATIENT HAD A IRREPARABLE ROTATOR CUFF AND THAT THE HUMERAL COMPONENT SEEMED TO BE LOOSE. THE PRIMARY COMPONENTS WERE REMOVED AND THE SURGEON REPLACED THEM WITH A DELTA REVERSE SHOULDER PROSTHESIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7348326 ↗
Other PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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