prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented
FDA product code PAO · Class 2 · 124 devices · 1,038 reports · 5 deaths reported · 2 devices named in recalls
- Comprehensive Reverse Shoulder 115310Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death99 reports
- INHANCE 5120-00-110Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented75 reports
- Comprehensive® Reverse Shoulder XL-115364Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall7 reports
- Comprehensive® Reverse Shoulder XL-115366Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall4 reports
- Comprehensive® Reverse Shoulder 180550Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 deaths43 reports
- DJO SURGICAL 521-07-246Encore Medical, L.P. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented42 reports
- Comprehensive® Reverse Shoulder 180551Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented42 reports
- Comprehensive® 110031399Zimmer, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death36 reports
- Comprehensive® Reverse Shoulder 115396Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented35 reports
- INHANCE 5500-00-360Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented30 reports
- COMPREHENSIVE® REVERSE SHOULDER 110032410Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death29 reports
- Comprehensive® Reverse Shoulder XL-115363Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented27 reports
- INHANCE 5500-36-100Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented24 reports
- INHANCE 5500-36-004Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented23 reports
- Comprehensive® Prolong® 110031418Zimmer, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented20 reports
- Comprehensive® Vivacit-E® 110031427Zimmer, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented17 reports
- DJO SURGICAL 521-01-242Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented17 reports
- INHANCE 5100-26-500Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented17 reports
- Comprehensive® Reverse Shoulder 115397Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented16 reports
- Comprehensive® Versa-Dial® 110030776Zimmer, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented16 reports
- INHANCE 5500-11-240Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented16 reports
- Comprehensive® Vivacit-E® 110031428Zimmer, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented14 reports
- INHANCE 5503-10-015Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented14 reports
- INHANCE 5505-36-104Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented14 reports
- DJO SURGICAL 520-42-216Encore Medical, L.P. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented13 reports
- INHANCE 5505-40-004Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented13 reports
- TORNIER PERFORM™ HUMERAL SYSTEM DWX2PSTornier, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented12 reports
- INHANCE 5200-00-040Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented12 reports
- INHANCE 5505-32-008Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented12 reports
- DJO SURGICAL 520-10-000Encore Medical, L.P. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented11 reports
- Comprehensive® Reverse Shoulder 115340Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented11 reports
- Comprehensive® Reverse Shoulder 115394Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented10 reports
- INHANCE 5500-01-290Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented10 reports
- INHANCE 5500-40-004Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented10 reports
- Comprehensive® 110031402Zimmer, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented9 reports
- Comprehensive® 110031407Zimmer, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented9 reports
- DJO SURGICAL 521-01-246Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented9 reports
- Anatomical Shoulder™ Domelock® 01.04227.005Zimmer GmbH · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented9 reports
- Comprehensive® Reverse Shoulder 180560Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented8 reports
- DJO SURGICAL 521-01-250Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented8 reports
- Comprehensive® Reverse Shoulder 115400Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented7 reports
- Comprehensive® Reverse Shoulder 180556Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented7 reports
- DJO SURGICAL 521-01-238Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented7 reports
- INHANCE 5507-06-100Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented7 reports
- DJO SURGICAL 520-50-318Encore Medical, L.P. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented6 reports
- DJO SURGICAL 520-14-000Encore Medical, L.P. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented5 reports
- DJO SURGICAL 520-40-214Encore Medical, L.P. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented5 reports
- DJO SURGICAL 520-54-220Encore Medical, L.P. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented5 reports
- DJO SURGICAL 520-54-320Encore Medical, L.P. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented5 reports
- Comprehensive® Reverse Shoulder XL-115365Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented5 reports
- DJO SURGICAL 521-01-254Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented5 reports
- INHANCE 5200-01-032Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented5 reports
- INHANCE 5503-00-020Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented5 reports
- DJO SURGICAL 520-54-318Encore Medical, L.P. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented4 reports
- DJO SURGICAL 804-09-027Encore Medical, L.P. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented4 reports
- PERFORM™ HUMERAL SYSTEM DWS1360Tornier, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented4 reports
- PERFORM™ HUMERAL SYSTEM DWS2390Tornier, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented4 reports
- DJO SURGICAL 520-01-150Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented4 reports
- Anatomical Shoulder™ Domelock® 01.04212.465Zimmer GmbH · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented4 reports
- INHANCE 5200-01-028Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented4 reports
- INHANCE 5200-00-032Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented4 reports
- DJO SURGICAL 520-40-216Encore Medical, L.P. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented3 reports
- TORNIER PERFORM™ HUMERAL SYSTEM DWX1PLTornier, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented3 reports
- Comprehensive Reverse Shoulder EP-115395Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented3 reports
- Anatomical Shoulder™ Domelock® 01.04212.505Zimmer GmbH · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented3 reports
- PERFORM™ HUMERAL SYSTEM DWS2360Tornier, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 reports
- PERFORM™ HUMERAL SYSTEM DWS3363Tornier, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 reports
- PERFORM™ HUMERAL SYSTEM DWT4366Tornier, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 reports
- Comprehensive® Reverse Shoulder 115345Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 reports
- Comprehensive® Reverse Shoulder XL-115368Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 reports
- Comprehensive Reverse Shoulder EP-115396Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 reports
- Comprehensive® Reverse Shoulder 180558Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 reports
- COMPREHENSIVE SHOULDER 110005273Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 reports
- Comprehensive® Reverse Shoulder 180562Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 reports
- Comprehensive Reverse Shoulder TI-115326Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 reports
- Comprehensive® 110031406Zimmer, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 reports
- DJO SURGICAL 521-01-154Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented2 reports
- Anatomical Shoulder™ Domelock® 01.04212.445Zimmer GmbH · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 reports
- Anatomical Shoulder™ Domelock® 01.04212.485Zimmer GmbH · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 reports
- SMR Shoulder 1360.54.820Limacorporate SPA · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented2 reports
- INHANCE 5507-08-100Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 reports
- INHANCE 5100-21-522Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 reports
- INHANCE 5155-00-240Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 reports
- DJO SURGICAL 804-07-149Encore Medical, L.P. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- DJO SURGICAL 804-07-540Encore Medical, L.P. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- DJO SURGICAL 520-07-246Encore Medical, L.P. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- PERFORM™ HUMERAL SYSTEM DWS1363Tornier, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- PERFORM™ HUMERAL SYSTEM DWS1390Tornier, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- PERFORM™ HUMERAL SYSTEM DWS2363Tornier, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- PERFORM™ HUMERAL SYSTEM DWS2420Tornier, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- PERFORM™ HUMERAL SYSTEM DWS2426Tornier, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- PERFORM™ HUMERAL SYSTEM DWS3360Tornier, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- PERFORM™ HUMERAL SYSTEM DWS3390Tornier, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- PERFORM™ HUMERAL SYSTEM DWS4360Tornier, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- PERFORM™ HUMERAL SYSTEM DWS4390Tornier, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- PERFORM™ HUMERAL SYSTEM DWS4396Tornier, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- PERFORM™ HUMERAL SYSTEM DWT1363Tornier, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- PERFORM™ HUMERAL SYSTEM DWT2420Tornier, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- PERFORM™ HUMERAL SYSTEM DWT4393Tornier, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- PERFORM™ HUMERAL SYSTEM DWT4423Tornier, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report