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36mm BIOLOX delta Femoral Head, 12/14 taper, +0mm Head Length
Model 3203.36.000 · TOTAL JOINT ORTHOPEDICS, INC. · DI 00814703011573
LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented · Class II · 21 CFR 888.3358
LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented · Class II · 21 CFR 888.3353
MBL — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous · Class II · 21 CFR 888.3358
UDILibrary device dossier · generated 2026-09-07 · 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
3.21
2019-02
0
2.72
2019-03
0
3.16
2019-04
0
2.94
2019-05
0
2.27
2019-06
0
1.93
2019-07
0
1.91
2019-08
0
2.27
2019-09
0
2.56
2019-10
0
2.84
2019-11
0
2.4
2019-12
0
2.72
2020-01
0
3.16
2020-02
0
2.71
2020-03
0
3.49
2020-04
0
2.46
2020-05
0
2.36
2020-06
0
2.3
2020-07
0
2.75
2020-08
0
2.2
2020-09
0
2.83
2020-10
0
2.82
2020-11
0
2.54
2020-12
0
2.56
2021-01
0
2.73
2021-02
0
2.26
2021-03
0
2.26
2021-04
0
2.28
2021-05
0
2.18
2021-06
0
2.73
2021-07
0
2.62
2021-08
0
2.65
2021-09
0
2.73
2021-10
0
2.45
2021-11
0
2.27
2021-12
0
2.57
2022-01
0
2.32
2022-02
0
2.21
2022-03
0
2.49
2022-04
0
2.33
2022-05
0
2.36
2022-06
0
2.48
2022-07
0
2.3
2022-08
0
2.37
2022-09
0
2.41
2022-10
0
2.38
2022-11
0
2.47
2022-12
0
2.51
2023-01
0
2.59
2023-02
0
2.44
2023-03
0
2.71
2023-04
0
2.51
2023-05
0
2.4
2023-06
0
2.47
2023-07
0
2.3
2023-08
0
2.09
2023-09
0
2.07
2023-10
0
1.83
2023-11
0
1.77
2023-12
0
1.9
2024-01
0
1.87
2024-02
0
2.23
2024-03
0
2.02
2024-04
0
1.89
2024-05
0
2.18
2024-06
0
2.02
2024-07
0
1.84
2024-08
0
1.99
2024-09
0
2.17
2024-10
0
1.93
2024-11
0
1.97
2024-12
0
1.68
2025-01
0
2.14
2025-02
0
1.64
2025-03
0
1.86
2025-04
0
1.92
2025-05
0
1.91
2025-06
0
1.95
2025-07
0
1.95
2025-08
0
1.89
2025-09
0
1.81
2025-10
0
1.83
2025-11
0
1.86
2025-12
0
1.99
2026-01
0
2.05
2026-02
0
1.77
2026-03
0
1.98
2026-04
0
2.01
2026-05
0
1.81
2026-06
0
1.86
This device (reports/month)Average device in LPH, LZO, MBL (reports/device/month)