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DISCOVERY-MOSAIC ELBOW SYSTEM
Model 114890 · Biomet Orthopedics, LLC · DI 00880304215672
JDC — Prosthesis, Elbow, Constrained, Cemented · Class II · 21 CFR 888.3150
KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3650
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 (0)
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.
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
1.85
2019-02
0
1.44
2019-03
0
1.25
2019-04
0
2.27
2019-05
0
2.13
2019-06
0
1.86
2019-07
0
1.71
2019-08
0
2.15
2019-09
0
1.69
2019-10
0
2.07
2019-11
0
1.32
2019-12
0
2.05
2020-01
0
1.7
2020-02
0
2.04
2020-03
0
1.83
2020-04
0
1.33
2020-05
0
1.93
2020-06
0
2.24
2020-07
0
1.79
2020-08
0
2.19
2020-09
0
2.5
2020-10
0
2.59
2020-11
0
2
2020-12
0
1.89
2021-01
0
1.92
2021-02
0
1.46
2021-03
0
1.73
2021-04
0
1.84
2021-05
0
1.45
2021-06
0
1.52
2021-07
0
1.97
2021-08
0
2.34
2021-09
0
1.91
2021-10
0
2.11
2021-11
0
1.74
2021-12
0
2.27
2022-01
0
2.07
2022-02
0
2.43
2022-03
0
2.2
2022-04
0
2.09
2022-05
0
1.78
2022-06
0
2.45
2022-07
0
2.13
2022-08
0
2.06
2022-09
0
1.98
2022-10
0
1.67
2022-11
0
1.97
2022-12
0
2
2023-01
0
1.79
2023-02
0
1.63
2023-03
0
1.69
2023-04
0
1.65
2023-05
0
1.68
2023-06
0
1.71
2023-07
0
1.9
2023-08
0
1.65
2023-09
0
1.43
2023-10
0
1.48
2023-11
0
1.59
2023-12
0
1.31
2024-01
0
1.67
2024-02
0
2.04
2024-03
0
1.62
2024-04
0
1.75
2024-05
0
1.59
2024-06
0
1.92
2024-07
0
1.53
2024-08
0
1.66
2024-09
0
2.59
2024-10
0
1.66
2024-11
0
1.71
2024-12
0
1.79
2025-01
0
1.69
2025-02
0
1.68
2025-03
0
1.69
2025-04
0
2.02
2025-05
0
2.09
2025-06
0
1.75
2025-07
0
1.48
2025-08
0
1.89
2025-09
0
1.34
2025-10
0
1.59
2025-11
0
1.74
2025-12
0
1.98
2026-01
0
1.72
2026-02
0
1.42
2026-03
0
1.57
2026-04
0
1.68
2026-05
0
1.55
2026-06
0
1.52
This device (reports/month)Average device in JDC, KWT (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K020045 — cited as predicate by K111746, K112905
K033280 — cited as predicate by K111746, K112905
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Biomet Orthopedics, LLC