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Latitude™ - Elbow
Model DKY068 · TORNIER, INC. · DI 00846832010912
JDB — Prosthesis, Elbow, Semi-Constrained, Cemented · Class II · 21 CFR 888.3160
JDC — Prosthesis, Elbow, Constrained, Cemented · Class II · 21 CFR 888.3150
UDILibrary device dossier · generated 2026-09-11 · 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 (34)
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.
Injury: 34
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
1.33
2019-02
0
1
2019-03
0
1
2019-04
0
1
2019-05
0
1
2019-06
0
1.25
2019-08
0
1
2019-10
0
1
2019-11
0
1.22
2019-12
0
1.4
2020-01
0
1.2
2020-02
0
2.5
2020-04
0
2.33
2020-05
0
1
2020-06
0
1.9
2020-07
0
1
2020-08
0
1
2020-09
0
2
2020-10
0
1.67
2020-11
0
1.23
2020-12
0
1.5
2021-01
0
1.5
2021-02
0
1.17
2021-03
0
1.17
2021-04
0
1.14
2021-05
0
3
2021-06
0
1.7
2021-07
0
1.5
2021-08
0
1.67
2021-09
0
1.67
2021-10
0
1.75
2021-11
0
1.33
2021-12
0
2.25
2022-01
0
1.44
2022-02
0
1.44
2022-03
0
2.14
2022-04
0
1.78
2022-05
0
2.29
2022-06
0
1.5
2022-07
0
1.56
2022-08
3
2.08
2022-09
0
2.17
2022-10
0
2
2022-11
0
2.19
2022-12
0
2
2023-01
0
2.5
2023-02
0
1.4
2023-03
0
2.27
2023-04
0
1.43
2023-05
0
1.54
2023-06
0
1.67
2023-07
0
1.63
2023-08
0
1.36
2023-09
0
1.22
2023-10
0
1.64
2023-11
0
1.31
2023-12
0
1.13
2024-01
2
2.21
2024-02
0
1
2024-03
2
1.53
2024-04
0
1.41
2024-05
0
1.2
2024-06
6
2.33
2024-07
0
1.39
2024-08
4
2.05
2024-09
4
3.93
2024-10
2
1.61
2024-11
0
1.58
2024-12
0
1
2025-01
0
1.21
2025-02
0
1.22
2025-03
0
1.11
2025-04
1
1.29
2025-05
0
1
2025-06
0
1.15
2025-07
0
1.21
2025-08
0
1.33
2025-09
0
1.17
2025-10
4
2.03
2025-11
2
1.87
2025-12
0
1.67
2026-01
0
1
2026-02
0
1
2026-03
2
1.33
2026-04
2
1.55
2026-05
0
1.48
2026-06
0
1
This device (reports/month)Average device in JDB, JDC (reports/device/month)