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Trabecular Metal®
Model 6202-56-20 · Zimmer, Inc. · DI 00889024118928
JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented · Class II · 21 CFR 888.3350
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
LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented · Class II · 21 CFR 888.3353
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 (3)
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.
Malfunction: 2 · Injury: 1
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
3.19
2019-02
0
2.69
2019-03
0
3.05
2019-04
0
2.85
2019-05
0
2.23
2019-06
0
1.91
2019-07
0
1.93
2019-08
0
2.21
2019-09
0
2.5
2019-10
0
2.71
2019-11
0
2.24
2019-12
0
2.59
2020-01
0
3.01
2020-02
0
2.67
2020-03
0
3.38
2020-04
0
2.35
2020-05
0
2.34
2020-06
0
2.13
2020-07
0
2.63
2020-08
0
2.11
2020-09
0
2.68
2020-10
0
2.67
2020-11
0
2.43
2020-12
0
2.43
2021-01
0
2.56
2021-02
0
2.15
2021-03
0
2.13
2021-04
0
2.13
2021-05
0
2.1
2021-06
0
2.59
2021-07
0
2.44
2021-08
0
2.37
2021-09
0
2.49
2021-10
0
2.29
2021-11
0
2.17
2021-12
0
2.42
2022-01
0
2.17
2022-02
0
2.17
2022-03
0
2.26
2022-04
0
2.24
2022-05
0
2.2
2022-06
0
2.31
2022-07
0
2.16
2022-08
0
2.22
2022-09
0
2.24
2022-10
0
2.21
2022-11
0
2.31
2022-12
0
2.31
2023-01
0
2.3
2023-02
0
2.18
2023-03
0
2.43
2023-04
0
2.3
2023-05
0
2.24
2023-06
0
2.31
2023-07
0
2.15
2023-08
0
2
2023-09
0
1.99
2023-10
0
1.7
2023-11
1
1.66
2023-12
0
1.76
2024-01
0
1.77
2024-02
0
2.1
2024-03
0
1.96
2024-04
1
1.78
2024-05
0
2.08
2024-06
0
1.92
2024-07
0
1.76
2024-08
0
1.88
2024-09
0
2.03
2024-10
0
1.79
2024-11
0
1.79
2024-12
0
1.59
2025-01
0
1.95
2025-02
0
1.54
2025-03
0
1.79
2025-04
0
1.83
2025-05
0
1.74
2025-06
0
1.86
2025-07
0
1.84
2025-08
0
1.72
2025-09
0
1.75
2025-10
0
1.74
2025-11
1
1.81
2025-12
0
1.91
2026-01
0
2
2026-02
0
1.67
2026-03
0
1.96
2026-04
0
1.93
2026-05
0
1.75
2026-06
0
1.76
This device (reports/month)Average device in JDI, KWZ, LPH, LZO (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K021891 — cited as predicate by K093561, K112898, K241636