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Trilogy® Longevity®
Model 00-6334-078-36 · Zimmer, Inc. · DI 00889024669000
KWZ — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer · Class II · 21 CFR 888.3310
LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented · 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
3.42
2019-02
0
2.87
2019-03
0
3.35
2019-04
0
3.04
2019-05
0
2.38
2019-06
0
1.96
2019-07
0
2.03
2019-08
0
2.28
2019-09
0
2.76
2019-10
0
3.03
2019-11
0
2.44
2019-12
0
2.79
2020-01
0
3.16
2020-02
0
2.83
2020-03
0
3.56
2020-04
0
2.45
2020-05
0
2.39
2020-06
0
2.27
2020-07
0
2.73
2020-08
0
2.16
2020-09
0
2.8
2020-10
0
2.75
2020-11
0
2.62
2020-12
0
2.57
2021-01
0
2.8
2021-02
0
2.2
2021-03
0
2.19
2021-04
0
2.25
2021-05
0
2.12
2021-06
0
2.81
2021-07
0
2.49
2021-08
0
2.5
2021-09
0
2.52
2021-10
0
2.34
2021-11
0
2.18
2021-12
0
2.47
2022-01
0
2.23
2022-02
0
1.95
2022-03
0
2.4
2022-04
0
2.26
2022-05
0
2.16
2022-06
0
2.45
2022-07
0
2.16
2022-08
0
2.23
2022-09
0
2.25
2022-10
0
2.22
2022-11
0
2.29
2022-12
0
2.35
2023-01
0
2.38
2023-02
0
2.23
2023-03
0
2.63
2023-04
0
2.4
2023-05
0
2.25
2023-06
0
2.31
2023-07
0
2.1
2023-08
0
1.97
2023-09
0
1.93
2023-10
0
1.72
2023-11
0
1.65
2023-12
0
1.75
2024-01
0
1.78
2024-02
0
2.17
2024-03
0
1.93
2024-04
0
1.76
2024-05
0
1.91
2024-06
0
1.88
2024-07
0
1.78
2024-08
0
1.79
2024-09
0
2.04
2024-10
0
1.83
2024-11
0
1.8
2024-12
0
1.54
2025-01
0
1.96
2025-02
0
1.52
2025-03
0
1.83
2025-04
0
1.81
2025-05
0
1.76
2025-06
0
1.86
2025-07
0
1.88
2025-08
0
1.66
2025-09
0
1.74
2025-10
0
1.71
2025-11
0
1.72
2025-12
0
1.88
2026-01
0
1.98
2026-02
0
1.61
2026-03
0
1.86
2026-04
0
1.86
2026-05
0
1.56
2026-06
0
1.73
This device (reports/month)Average device in KWZ, LPH (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K071718 — cited as predicate by K092265, K093561, K101730, K212512
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Zimmer, Inc.
Warning Letter 2016-05-27 Orthosoft, Inc.
Warning Letter 2012-09-19 Zimmer Manufacturing B.V.
NAI 2022-07-27 Zimmer, Inc. · 0 citations
NAI 2022-07-27 Zimmer, Inc. · 0 citations
NAI 2020-10-01 Zimmer Manufacturing B.V. · 0 citations
VAI 2017-10-16 Zimmer, Inc. · 8 citations
VAI 2017-10-16 Zimmer, Inc. · 8 citations
NAI 2017-09-01 Zimmer Trabecular Metal Technology, Inc. · 0 citations
VAI 2017-07-27 ZIMMER ORTHOPEDIC MFG LTD · 3 citations
VAI 2017-07-20 Zimmer Manufacturing B.V. · 3 citations
VAI 2016-05-23 Zimmer Surgical Inc · 4 citations
OAI 2015-11-20 Zimmer, Inc. · 10 citations
OAI 2015-11-20 Zimmer, Inc. · 10 citations
VAI 2015-11-17 Zimmer Manufacturing B.V. · 4 citations
VAI 2015-05-11 Zimmer Trabecular Metal Technology, Inc. · 3 citations
VAI 2014-10-16 ZIMMER ORTHOPEDIC MFG LTD · 2 citations