Humelock II Cemented Reversible Shoulder
Model 103-0803 · FX SOLUTIONS · DI 03701037300091
PHX — Shoulder Prosthesis, Reverse Configuration · Class II · 21 CFR 888.3660
UDILibrary device dossier · generated 2026-09-11 · 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 (221)
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: 221
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.1 |
| 2019-02 | 0 | 2.32 |
| 2019-03 | 0 | 1.9 |
| 2019-04 | 0 | 2.37 |
| 2019-05 | 0 | 2.59 |
| 2019-06 | 1 | 1.9 |
| 2019-07 | 0 | 2.22 |
| 2019-08 | 0 | 2.61 |
| 2019-09 | 1 | 1.98 |
| 2019-10 | 1 | 2.02 |
| 2019-11 | 0 | 1.86 |
| 2019-12 | 0 | 1.81 |
| 2020-01 | 3 | 2.03 |
| 2020-02 | 2 | 1.99 |
| 2020-03 | 12 | 2.77 |
| 2020-04 | 1 | 1.94 |
| 2020-05 | 1 | 1.92 |
| 2020-06 | 3 | 2.12 |
| 2020-07 | 8 | 2.78 |
| 2020-08 | 3 | 1.9 |
| 2020-09 | 1 | 2.01 |
| 2020-10 | 0 | 2.32 |
| 2020-11 | 1 | 1.97 |
| 2020-12 | 1 | 1.94 |
| 2021-01 | 0 | 2.64 |
| 2021-02 | 5 | 2.25 |
| 2021-03 | 1 | 2.39 |
| 2021-04 | 2 | 2.35 |
| 2021-05 | 0 | 2.25 |
| 2021-06 | 0 | 2.32 |
| 2021-07 | 0 | 2.38 |
| 2021-08 | 2 | 2.45 |
| 2021-09 | 2 | 2.35 |
| 2021-10 | 6 | 2.85 |
| 2021-11 | 0 | 2.36 |
| 2021-12 | 10 | 3.62 |
| 2022-01 | 6 | 3.42 |
| 2022-02 | 1 | 2.83 |
| 2022-03 | 39 | 3.44 |
| 2022-04 | 20 | 3.11 |
| 2022-05 | 0 | 2.47 |
| 2022-06 | 9 | 2.58 |
| 2022-07 | 0 | 2.41 |
| 2022-08 | 0 | 2.61 |
| 2022-09 | 0 | 2.37 |
| 2022-10 | 0 | 2.45 |
| 2022-11 | 0 | 2.38 |
| 2022-12 | 3 | 2.59 |
| 2023-01 | 6 | 2.04 |
| 2023-02 | 0 | 2.27 |
| 2023-03 | 3 | 2.22 |
| 2023-04 | 0 | 2.56 |
| 2023-05 | 6 | 2.29 |
| 2023-06 | 9 | 2.39 |
| 2023-07 | 11 | 2.16 |
| 2023-08 | 2 | 1.92 |
| 2023-09 | 0 | 1.71 |
| 2023-10 | 2 | 1.74 |
| 2023-11 | 4 | 1.84 |
| 2023-12 | 4 | 1.52 |
| 2024-01 | 0 | 1.74 |
| 2024-02 | 1 | 2.03 |
| 2024-03 | 0 | 1.8 |
| 2024-04 | 1 | 1.99 |
| 2024-05 | 1 | 1.73 |
| 2024-06 | 1 | 1.88 |
| 2024-07 | 1 | 1.69 |
| 2024-08 | 0 | 1.77 |
| 2024-09 | 1 | 1.77 |
| 2024-10 | 5 | 1.9 |
| 2024-11 | 2 | 1.72 |
| 2024-12 | 0 | 1.71 |
| 2025-01 | 1 | 1.77 |
| 2025-02 | 0 | 1.77 |
| 2025-03 | 0 | 2.04 |
| 2025-04 | 1 | 1.87 |
| 2025-05 | 0 | 1.94 |
| 2025-06 | 2 | 2.13 |
| 2025-07 | 1 | 1.89 |
| 2025-08 | 0 | 1.73 |
| 2025-09 | 0 | 1.54 |
| 2025-10 | 3 | 1.77 |
| 2025-11 | 1 | 1.78 |
| 2025-12 | 0 | 2.29 |
| 2026-01 | 1 | 2.02 |
| 2026-02 | 0 | 1.93 |
| 2026-03 | 0 | 1.88 |
| 2026-04 | 1 | 1.78 |
| 2026-05 | 1 | 1.86 |
| 2026-06 | 4 | 1.95 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K150488 — cites (transitively): K053274 (d1), K123814 (d1), K130759 (d1), K132285 (d1), K140071 (d1), K060874 (d2), K111097 (d2), K992525 (d2), K994392 (d2) — cited as predicate by K162455, K163669, K191146, K192799, K193394, K210790, K222936
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — FX SOLUTIONS
Nothing in the loaded window.