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Adapter for BIOLOX OPTION Femoral Head, -3.5mm head length
Model 3301.00.035 · TOTAL JOINT ORTHOPEDICS, INC. · DI 00814703011627
LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented · Class II · 21 CFR 888.3358
MBL — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous · Class II · 21 CFR 888.3358
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 (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
3.53
2019-02
0
2.93
2019-03
0
3.42
2019-04
0
3.15
2019-05
0
2.42
2019-06
0
2
2019-07
0
2.06
2019-08
0
2.33
2019-09
0
2.82
2019-10
0
3.11
2019-11
0
2.55
2019-12
0
2.85
2020-01
0
3.22
2020-02
0
2.84
2020-03
0
3.7
2020-04
0
2.54
2020-05
0
2.43
2020-06
0
2.43
2020-07
0
2.87
2020-08
0
2.2
2020-09
0
2.84
2020-10
0
2.87
2020-11
0
2.64
2020-12
0
2.64
2021-01
0
2.9
2021-02
0
2.28
2021-03
0
2.31
2021-04
0
2.38
2021-05
0
2.18
2021-06
0
2.93
2021-07
0
2.66
2021-08
0
2.72
2021-09
0
2.71
2021-10
0
2.44
2021-11
0
2.32
2021-12
0
2.66
2022-01
0
2.33
2022-02
0
2.11
2022-03
0
2.59
2022-04
0
2.36
2022-05
0
2.27
2022-06
0
2.63
2022-07
0
2.28
2022-08
0
2.39
2022-09
0
2.39
2022-10
0
2.36
2022-11
0
2.45
2022-12
0
2.53
2023-01
0
2.56
2023-02
0
2.53
2023-03
0
2.9
2023-04
0
2.57
2023-05
0
2.45
2023-06
0
2.49
2023-07
0
2.29
2023-08
0
2.16
2023-09
0
2.1
2023-10
0
1.85
2023-11
0
1.75
2023-12
0
1.9
2024-01
0
1.89
2024-02
0
2.25
2024-03
0
2.03
2024-04
0
1.88
2024-05
0
2.12
2024-06
0
2.04
2024-07
0
1.86
2024-08
0
1.94
2024-09
0
2.27
2024-10
0
1.99
2024-11
0
1.94
2024-12
0
1.65
2025-01
0
2.1
2025-02
0
1.61
2025-03
0
1.87
2025-04
0
1.89
2025-05
0
1.88
2025-06
0
1.93
2025-07
0
1.98
2025-08
0
1.83
2025-09
0
1.89
2025-10
0
1.82
2025-11
0
1.82
2025-12
0
1.98
2026-01
0
2.05
2026-02
0
1.71
2026-03
0
1.97
2026-04
0
1.91
2026-05
0
1.69
2026-06
0
1.85
This device (reports/month)Average device in LPH, MBL (reports/device/month)