GLOBAL STEPTECH 1130-44-105Recalls & reported problems
Depuy Orthopaedics, Inc. · GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 44 +5mm LEFT CEMENTED · Class 2 · Implant
Data updated Oct 18, 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 10603295005803), received between Oct 14, 2020 and Oct 14, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Joint Dislocation1
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 14, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT RECEIVED TOTAL LEFT SHOULDER INDEX SURGERY. DR. HAD TO CLOSE REDUCE THE PATIENT'S LEFT SHOULDER DUE TO A POSTERIOR DISLOCATION OF THE HUMERAL HEAD ON (B)(6) 2019. DR ELECTED TO REVISE THE PATIENTS LEFT SHOULDER FROM AN ANATOMIC TO A REVERSE SHOULDER ON (B)(6) 2020. DR. REMOVED THE INDEX COMPONENTS. ALL WERE WELL FIXED. THERE WERE NO LOOSE COMPONENTS. THERE WAS NO MENTION BY ANYONE THAT THE COMPONENTS CONTRIBUTED TO THE NEED TO REVISE THE SHOULDER. NO PIECES OR INSTRUMENTS BROKE DURING THE CASE AND THERE WAS NO EXTENSION IN TIME AS A RESULT OF DEPUY PRODUCTS.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 10680422 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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