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Unnamed device
Model 2347-22-60 · Zimmer, Inc. · DI 00889024052314
HWC — Screw, Fixation, Bone · Class II · 21 CFR 888.3040
LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented · Class II · 21 CFR 888.3358
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
3.24
2019-02
0
2.82
2019-03
0
3.14
2019-04
0
3.09
2019-05
0
2.31
2019-06
0
2.04
2019-07
0
2.15
2019-08
0
2.35
2019-09
0
2.67
2019-10
0
2.94
2019-11
0
2.54
2019-12
0
2.91
2020-01
0
3.23
2020-02
0
2.8
2020-03
0
3.51
2020-04
0
2.51
2020-05
0
2.33
2020-06
0
2.42
2020-07
0
2.92
2020-08
0
2.42
2020-09
0
2.87
2020-10
0
2.78
2020-11
0
2.84
2020-12
0
2.67
2021-01
0
2.53
2021-02
0
2.36
2021-03
0
2.48
2021-04
0
2.58
2021-05
0
2.32
2021-06
0
2.76
2021-07
0
2.59
2021-08
0
2.58
2021-09
0
2.66
2021-10
0
2.39
2021-11
0
2.39
2021-12
0
2.66
2022-01
0
2.61
2022-02
0
2.18
2022-03
0
2.49
2022-04
0
2.31
2022-05
0
2.37
2022-06
0
2.59
2022-07
0
2.32
2022-08
0
2.51
2022-09
0
2.65
2022-10
0
2.66
2022-11
0
2.74
2022-12
0
3.65
2023-01
0
2.68
2023-02
0
2.69
2023-03
0
3.02
2023-04
0
2.74
2023-05
0
2.81
2023-06
0
2.71
2023-07
0
2.32
2023-08
0
2.19
2023-09
0
2.1
2023-10
0
2
2023-11
0
1.83
2023-12
0
2.11
2024-01
0
2.22
2024-02
0
2.12
2024-03
0
2.19
2024-04
0
2.01
2024-05
0
2.21
2024-06
0
2.14
2024-07
0
2.07
2024-08
0
2.04
2024-09
0
2.26
2024-10
0
2.06
2024-11
0
2.03
2024-12
0
1.98
2025-01
0
2.18
2025-02
0
1.82
2025-03
0
1.96
2025-04
0
2.11
2025-05
0
2.11
2025-06
0
1.98
2025-07
0
2.05
2025-08
0
2.05
2025-09
0
1.95
2025-10
0
2
2025-11
0
1.9
2025-12
0
2.22
2026-01
0
2.08
2026-02
0
1.94
2026-03
0
2.24
2026-04
0
2.03
2026-05
0
2.1
2026-06
0
2.02
This device (reports/month)Average device in HWC, LPH (reports/device/month)