Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
FDA product code KWS · Class 2 · 1,164 devices · 9,698 reports · 6 deaths reported · 85 devices named in recalls
- SOLAR 5361-6105Howmedica Osteonics Corp. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall0 reports
- SOLAR 5361-6209Howmedica Osteonics Corp. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall0 reports
- SOLAR 5361-6207Howmedica Osteonics Corp. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall0 reports
- SOLAR 5361-6211Howmedica Osteonics Corp. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall0 reports
- Anatomic Shoulder Prosthesis 04.01.0023Medacta International SA · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall0 reports
- Equinoxe 314-01-04Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall0 reports
- Equinoxe 314-13-25Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall0 reports
- Equinoxe 314-06-22Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall0 reports
- Equinoxe 314-06-24Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall0 reports
- Equinoxe 314-06-32Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall0 reports
- Equinoxe 314-06-33Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall0 reports
- Equinoxe 314-06-35Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall0 reports
- Equinoxe 314-23-15Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall0 reports
- Equinoxe 314-24-22Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall0 reports
- Equinoxe 314-24-33Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall0 reports
- Equinoxe 314-24-35Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall0 reports
- Equinoxe 301-11-11Exactech, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall0 reports
- REUNION 5901-1168Stryker GmbH · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED48 reports
- Comprehensive® Reverse Shoulder 180553Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 death47 reports
- GLOBAL 1136-43-026Depuy Orthopaedics, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 death43 reports
- Comprehensive Reverse Shoulder 115370Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED42 reports
- AETOS Shoulder System INS-0990-861Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED40 reports
- AEQUALIS REVERSED II DWD190Tornier · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED40 reports
- REUNION 5572-4516Stryker GmbH · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED39 reports
- GLOBAL UNITE 1100-30-000Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED37 reports
- Arthrex® AR-9236-01PPArthrex, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED36 reports
- DJO SURGICAL 520-01-246Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented36 reports
- COMPREHENSIVE INSTRUMENTATION 110028055Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED35 reports
- GLOBAL 1136-40-026Depuy Orthopaedics, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED35 reports
- FLEX SHOULDER SYSTEM DWF361BTornier · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED33 reports
- REUNION 5572-2800Stryker GmbH · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED33 reports
- DJO SURGICAL 533-08-048Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED32 reports
- Tornier Flex Shoulder System DWF421BTornier · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED32 reports
- Comprehensive® Reverse Shoulder 405800Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED31 reports
- Arthrex® AR-9105-02Arthrex, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED31 reports
- FLEX SHOULDER SYSTEM DWF510Tornier · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED31 reports
- DELTA XTEND 1307-62-038Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED31 reports
- DJO SURGICAL 521-07-238Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED30 reports
- DJO SURGICAL 520-00-000Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented30 reports
- AEQUALIS REVERSED II DWD193Tornier · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED30 reports
- AEQUALIS REVERSED DWB993Tornier · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED29 reports
- FLEX SHOULDER SYSTEM DWF520Tornier · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED29 reports
- DJO SURGICAL 533-12-108Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED28 reports
- Comprehensive® Reverse Shoulder 180554Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED28 reports
- Comprehensive® Instrumentation 110028879Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED28 reports
- DJO SURGICAL 510-00-008Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented28 reports
- Tornier Flex Shoulder System DWF602BTornier · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED28 reports
- GLOBAL UNITE 1100-40-000Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED28 reports
- GLOBAL AP 1130-02-000Depuy Orthopaedics, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED28 reports
- Tornier Flex Shoulder System DWF604BTornier · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED27 reports
- DJO SURGICAL 533-12-048Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED26 reports
- DJO SURGICAL 510-00-010Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented26 reports
- DJO SURGICAL 520-01-242Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented26 reports
- DJO SURGICAL 520-01-250Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented26 reports
- AEQUALIS REVERSED DWD132Tornier · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED26 reports
- DJO SURGICAL 508-36-107Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED25 reports
- Tornier Flex Shoulder System DWF605BTornier · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED25 reports
- DJO SURGICAL 533-10-048Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED24 reports
- Tornier HRS ARS655200Tornier, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED24 reports
- AEQUALIS REVERSED DWB960Tornier · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED24 reports
- AEQUALIS REVERSED II DWD182Tornier · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED24 reports
- Tornier Perform® Reversed Augmented Glenoid DWJ515Tornier, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED23 reports
- DJO SURGICAL 508-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented23 reports
- DELTA XTEND 130710100Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED23 reports
- Hybrid Glenoid PT-113950Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED22 reports
- DJO SURGICAL 520-01-006Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented22 reports
- DJO SURGICAL 520-01-238Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented21 reports
- AEQUALIS REVERSED II DWD181Tornier · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED21 reports
- Comprehensive® 110031405Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED20 reports
- REUNION 5572-4524Stryker GmbH · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED20 reports
- AEQUALIS REVERSED DWD126Tornier · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED19 reports
- Equinoxe 321-25-38Exactech, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED19 reports
- Tornier HRS ARS741701Tornier, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED18 reports
- DJO SURGICAL 510-08-000Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented18 reports
- DJO SURGICAL 509-00-444Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED18 reports
- GLOBAL UNITE 1100-20-000Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED18 reports
- DJO SURGICAL 520-12-000Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED17 reports
- Tornier Perform® Reversed Glenoid DWJ330Tornier, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED17 reports
- DJO SURGICAL 510-00-012Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented17 reports
- Trabecular Metal® 00-4349-036-11Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED17 reports
- Alliance® SBGL5001Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED17 reports
- GLOBAL UNITE 1100-48-610Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED17 reports
- INHANCE 5500-01-240Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED17 reports
- DJO SURGICAL 521-07-254Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED16 reports
- Comprehensive® Instrumentation 110029136Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED16 reports
- DJO SURGICAL 520-46-016Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented16 reports
- Alliance™ Trabecular Metal™ SAGP0002Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED16 reports
- AEQUALIS REVERSED DWD138Tornier · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED16 reports
- Tornier Flex Shoulder System DWF712BTornier · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED16 reports
- REUNION 5570-3604Stryker GmbH · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED16 reports
- REUNION 5572-4528Stryker GmbH · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED16 reports
- REUNION 5572-4532Stryker GmbH · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED16 reports
- GLOBAL UNITE 1100-50-000Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED16 reports
- GLOBAL ADVANTAGE 1137-10-000Depuy Orthopaedics, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED16 reports
- DELTA XTEND 1307-61-138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED16 reports
- Delta Xtend 1309-60-111Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED16 reports
- Comprehensive Shoulder System 118000Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED15 reports
- COMPREHENSIVE INSTRUMENTATION 110029136Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED15 reports
- Arthrex® AR-9106-01Arthrex, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED15 reports
- DJO SURGICAL 520-01-010Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented15 reports