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COMPREHENSIVE INSTRUMENTATION
Model 110029132 · Biomet Orthopedics, LLC · DI 00880304731516
KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3660
PHX — Shoulder Prosthesis, Reverse Configuration · Class II · 21 CFR 888.3660
UDILibrary device dossier · generated 2026-09-12 · 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 (122)
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.
Malfunction: 121 · Injury: 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
1.85
2019-03
0
1.75
2019-04
0
1.88
2019-05
0
2.1
2019-06
0
1.88
2019-07
0
1.68
2019-08
0
2.18
2019-09
0
1.67
2019-10
0
1.88
2019-11
0
1.72
2019-12
0
1.77
2020-01
0
1.96
2020-02
1
2.08
2020-03
1
2.19
2020-04
1
1.8
2020-05
0
1.66
2020-06
1
1.95
2020-07
1
2.24
2020-08
0
1.76
2020-09
0
1.96
2020-10
0
2.2
2020-11
0
1.9
2020-12
3
1.87
2021-01
0
2.2
2021-02
1
1.99
2021-03
6
2.15
2021-04
4
2.02
2021-05
3
2.02
2021-06
3
1.91
2021-07
3
2.06
2021-08
3
2.19
2021-09
1
1.97
2021-10
0
2.18
2021-11
4
2.13
2021-12
1
2.6
2022-01
2
2.65
2022-02
0
2.35
2022-03
2
2.51
2022-04
2
2.48
2022-05
2
2.13
2022-06
1
2.24
2022-07
2
2.2
2022-08
3
2.27
2022-09
0
2.04
2022-10
1
2.12
2022-11
3
2.16
2022-12
1
2.1
2023-01
1
1.85
2023-02
1
2.06
2023-03
2
2.05
2023-04
4
2.22
2023-05
3
2.12
2023-06
1
2.32
2023-07
1
2.11
2023-08
2
1.76
2023-09
2
1.59
2023-10
4
1.64
2023-11
3
1.69
2023-12
2
1.46
2024-01
1
1.9
2024-02
2
1.89
2024-03
6
1.73
2024-04
3
1.87
2024-05
1
1.72
2024-06
0
1.89
2024-07
0
1.63
2024-08
0
1.73
2024-09
1
1.74
2024-10
1
1.73
2024-11
2
1.64
2024-12
1
1.67
2025-01
1
1.74
2025-02
3
1.65
2025-03
0
1.94
2025-04
0
1.73
2025-05
1
1.83
2025-06
1
1.96
2025-07
0
1.8
2025-08
0
1.61
2025-09
1
1.52
2025-10
0
1.69
2025-11
2
1.74
2025-12
0
2.19
2026-01
1
1.93
2026-02
1
1.85
2026-03
2
1.8
2026-04
6
1.74
2026-05
1
1.8
2026-06
2
1.8
This device (reports/month)Average device in KWS, PHX (reports/device/month)