GLOBAL STEPTECH 1130-52-005Recalls & reported problems
Depuy Orthopaedics, Inc. · GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 52 +5mm RIGHT CEMENTED · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295006176), received between Feb 19, 2021 and Feb 19, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Loss of or Failure to Bond1
- Osseointegration Problem1
Patient problems
- Inadequate Osseointegration1
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 19, 2021Loss of or Failure to Bond; Osseointegration Problem; Loss of or Failure to Bond; Osseointegration Problem
ON WEDNESDAY, (B)(6), DR. (B)(6) REVISED THE RIGHT SHOULDER OF A PATIENT DUE TO ASEPTIC LOOSENING OF A GLENOID COMPONENT. DR. (B)(6) HAD PREFORMED THE PRIMARY JOINT REPLACEMENT ON THIS PATIENT IN (B)(6) 2015 AT (B)(6) UNIVERSITY HOSPITAL. PATIENT RECENTLY PRESENTED IN DR. (B)(6) CLINIC WITH PAINFUL RIGHT SHOULDER. DR. (B)(6) AND PATIENT ELECTED TO REVISE THE SHOULDER. UPON EXPOSURE TO THE JOINT SPACE DR. (B)(6) REMOVED THE INDEX GLENOID WITH A PAIR OF KOCHERS. DR. (B)(6) ELECTED TO CONVERT THE PROSTHESIS CONSTRUCT TO A REVERSE SHOULDER. DR. (B)(6) THEN REMOVED THE WELL FIXED, IN GROWN SZ 14 GLOBAL UNITE PROXIMAL BODY AND 52 X21 ECCENTRIC HUMERAL HEAD AND LEFT THE WELL FIXED DISTAL HUMERAL SZ 14 STEM. DR. (B)(6) REMOVED THE 52 +5 STEP TECH GLENOID. DR. (B)(6) THEN CONVERTED TO A DELTA EXTEND CONSTRUCT. NO INSTRUMENTS OR PRODUCTS BROKE DURING SURGERY. THERE WAS NO DELAY IN SURGERY. DR. (B)(6) FOUND THE GLENOID TO BE LOOSE AND SENT FIVE TISSUE SPECIMENS FOR TESTING FOR INFECTION. DATE OF REVISION ON THE RIGHT SHOULDER WAS (B)(6) 2021 AT (B)(6) HOSPITAL.
Patient problems: Inadequate Osseointegration; Insufficient Information
MAUDE report 11353232 ↗
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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