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Comprehensive® Vivacit-E®
Model 110031424 · Zimmer, Inc. · DI 00887868231551
KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3660
KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3650
PAO — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented · Class II · 21 CFR 888.3660
PHX — Shoulder Prosthesis, Reverse Configuration · Class II · 21 CFR 888.3660
UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (49)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Injury: 45 · Malfunction: 3 · Death: 1
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
1.82
2019-02
0
1.78
2019-03
0
1.69
2019-04
0
1.94
2019-05
0
2.12
2019-06
0
1.89
2019-07
0
1.69
2019-08
0
2.18
2019-09
0
1.68
2019-10
0
1.91
2019-11
0
1.64
2019-12
0
1.79
2020-01
1
1.89
2020-02
0
2.05
2020-03
0
2.14
2020-04
0
1.72
2020-05
0
1.71
2020-06
0
2
2020-07
0
2.21
2020-08
0
1.83
2020-09
0
2
2020-10
0
2.24
2020-11
0
1.96
2020-12
0
1.88
2021-01
0
2.18
2021-02
0
1.88
2021-03
1
2.06
2021-04
0
2.02
2021-05
1
1.88
2021-06
0
1.84
2021-07
0
2.09
2021-08
0
2.22
2021-09
1
1.91
2021-10
0
2.15
2021-11
1
2.06
2021-12
0
2.52
2022-01
0
2.53
2022-02
0
2.34
2022-03
0
2.38
2022-04
0
2.4
2022-05
0
2.02
2022-06
1
2.26
2022-07
1
2.18
2022-08
0
2.19
2022-09
0
2.01
2022-10
0
2
2022-11
0
2.11
2022-12
0
2.05
2023-01
0
1.81
2023-02
1
1.94
2023-03
2
1.92
2023-04
1
2.12
2023-05
0
2
2023-06
1
2.18
2023-07
0
2.04
2023-08
1
1.7
2023-09
2
1.55
2023-10
0
1.58
2023-11
0
1.68
2023-12
0
1.43
2024-01
0
1.81
2024-02
0
1.9
2024-03
0
1.68
2024-04
2
1.84
2024-05
0
1.69
2024-06
3
1.84
2024-07
1
1.62
2024-08
0
1.69
2024-09
0
1.7
2024-10
0
1.7
2024-11
2
1.63
2024-12
0
1.66
2025-01
3
1.74
2025-02
0
1.65
2025-03
2
1.87
2025-04
0
1.77
2025-05
1
1.88
2025-06
1
1.91
2025-07
3
1.73
2025-08
1
1.65
2025-09
1
1.47
2025-10
0
1.63
2025-11
1
1.73
2025-12
2
2.18
2026-01
1
1.9
2026-02
1
1.75
2026-03
5
1.77
2026-04
0
1.72
2026-05
3
1.72
2026-06
1
1.73
This device (reports/month)Average device in KWS, KWT, PAO, PHX (reports/device/month)