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DJO SURGICAL
Model 934-36-260 · Encore Medical, L.P. · DI 00888912101066
LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented · 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
3.78
2019-02
0
3.22
2019-03
0
3.68
2019-04
0
3.37
2019-05
0
2.54
2019-06
0
2.14
2019-07
0
2.2
2019-08
0
2.5
2019-09
0
3.06
2019-10
0
3.39
2019-11
0
2.71
2019-12
0
3.06
2020-01
0
3.49
2020-02
0
3.08
2020-03
0
3.94
2020-04
0
2.72
2020-05
0
2.59
2020-06
0
2.56
2020-07
0
3.01
2020-08
0
2.39
2020-09
0
3.09
2020-10
0
3.06
2020-11
0
2.85
2020-12
0
2.78
2021-01
0
3.04
2021-02
0
2.39
2021-03
0
2.43
2021-04
0
2.53
2021-05
0
2.28
2021-06
0
3.08
2021-07
0
2.72
2021-08
0
2.84
2021-09
0
2.8
2021-10
0
2.5
2021-11
0
2.47
2021-12
0
2.77
2022-01
0
2.46
2022-02
0
2.17
2022-03
0
2.71
2022-04
0
2.5
2022-05
0
2.37
2022-06
0
2.76
2022-07
0
2.4
2022-08
0
2.53
2022-09
0
2.5
2022-10
0
2.48
2022-11
0
2.57
2022-12
0
2.64
2023-01
0
2.67
2023-02
0
2.6
2023-03
0
2.99
2023-04
0
2.72
2023-05
0
2.56
2023-06
0
2.62
2023-07
0
2.34
2023-08
0
2.21
2023-09
0
2.15
2023-10
0
1.93
2023-11
0
1.8
2023-12
0
1.93
2024-01
0
1.94
2024-02
0
2.35
2024-03
0
2.12
2024-04
0
1.94
2024-05
0
2.16
2024-06
0
2.08
2024-07
0
1.91
2024-08
0
1.98
2024-09
0
2.33
2024-10
0
2.02
2024-11
0
2.02
2024-12
0
1.67
2025-01
0
2.17
2025-02
0
1.65
2025-03
0
1.91
2025-04
0
1.91
2025-05
0
1.93
2025-06
0
1.97
2025-07
0
2
2025-08
0
1.86
2025-09
0
1.89
2025-10
0
1.81
2025-11
0
1.86
2025-12
0
2
2026-01
0
2.09
2026-02
0
1.73
2026-03
0
2.03
2026-04
0
1.95
2026-05
0
1.73
2026-06
0
1.86
This device (reports/month)Average device in LPH (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K072154 — cited as predicate by K112158, K112898, K130365, K180930, K191708, K241483
K974093 — cited as predicate by K112158, K112898, K140130, K141676, K172651, K191708
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Encore Medical, L.P.