Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Depuy Orthopaedics, Inc.'s record for this product code
Recent MDR events
1,886 adverse event reports on file
- Unknown Shoulder GlenosphereJul 30, 2026Malfunction1818910-2026-13042
- DELTA XTENDJul 30, 2026Injury1818910-2026-13059
- GLOBALJul 29, 2026Injury1818910-2026-12925
- UNK Shoulder GlenosphereJul 27, 2026Injury1818910-2026-12678
- GLOBALJul 20, 2026Injury1818910-2026-12280
- UNKNOWN SHOULDER GLENOSPHEREJul 14, 2026Injury1818910-2026-11917
- DELTA XTENDJul 10, 2026Injury1818910-2026-11727
- UNKNOWN SHOULDER CONSTRUCT GLOBAL APG+Jul 1, 2026Injury1818910-2026-11243
- GLOBALJun 30, 2026Injury1818910-2026-11133
- DELTA XTENDJun 9, 2026Injury1818910-2026-09863
Recalls
11 recall events for this product code
- TerminatedFeb 27, 2018
The screw in specific lots of the GLOBAL UNITE Anatomic Body and GLOBAL UNITE Fracture Body was inverted during assembly to the body, which will cause the humeral stem to sit proud and may cause surgical delays.
View FDA record ↗ - TerminatedJan 15, 2009
Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable.
View FDA record ↗ - TerminatedJan 15, 2009
Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable.
View FDA record ↗ - TerminatedJan 15, 2009
Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable.
View FDA record ↗ - TerminatedJan 15, 2009
Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable.
View FDA record ↗ - TerminatedJan 15, 2009
Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable.
View FDA record ↗ - TerminatedJan 15, 2009
Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable.
View FDA record ↗ - TerminatedJan 15, 2009
Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable.
View FDA record ↗ - TerminatedJan 15, 2009
Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable.
View FDA record ↗ - TerminatedNov 17, 2007
Package Integrity: The outer peelable pouch seals may be compromised due to creasing, although the inner pouch seals are intact.
View FDA record ↗
510(k) clearances
9 clearances for this product code
- K092122Jul 27, 2009
GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID
- K091751Jul 14, 2009
DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP
- K081620Jun 30, 2008
MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM
- K060874Jun 28, 2006
DEPUY GLOBAL AP SHOULDER SYSTEM
- K052472Oct 6, 2005
DEPUY GLOBAL SHOULDER CROSSLINK GLENOID
- K000575Mar 10, 2000
GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD
- K992065Jul 12, 1999
GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE ECCENTRIC HEAD
- K981487Jul 13, 1998
DEPUY GLOBAL SHOULDER GLENOID
- K974044Jan 22, 1998
GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD