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DJO SURGICAL

Model 509-02-040 · Encore Medical, L.P. · DI 00190446257639

HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented · Class II · 21 CFR 888.3690

KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3660

PHX — Shoulder Prosthesis, Reverse Configuration · Class II · 21 CFR 888.3660

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 (25)

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: 25

11232019-01: 0 reports for this device; peer average 1.81/device2019-02: 0 reports for this device; peer average 1.74/device2019-03: 0 reports for this device; peer average 1.72/device2019-04: 0 reports for this device; peer average 1.79/device2019-05: 0 reports for this device; peer average 2.02/device2019-06: 0 reports for this device; peer average 1.86/device2019-07: 2 reports for this device; peer average 1.58/device2019-08: 2 reports for this device; peer average 2.14/device2019-09: 2 reports for this device; peer average 1.65/device2019-10: 0 reports for this device; peer average 1.82/device2019-11: 0 reports for this device; peer average 1.7/device2019-12: 0 reports for this device; peer average 1.74/device2020-01: 0 reports for this device; peer average 1.98/device2020-02: 0 reports for this device; peer average 2.11/device2020-03: 0 reports for this device; peer average 1.99/device2020-04: 2 reports for this device; peer average 1.77/device2020-05: 0 reports for this device; peer average 1.65/device2020-06: 2 reports for this device; peer average 1.92/device2020-07: 0 reports for this device; peer average 2.16/device2020-08: 0 reports for this device; peer average 1.79/device2020-09: 2 reports for this device; peer average 1.97/device2020-10: 0 reports for this device; peer average 2.11/device2020-11: 0 reports for this device; peer average 1.88/device2020-12: 2 reports for this device; peer average 1.84/device2021-01: 0 reports for this device; peer average 2.11/device2021-02: 2 reports for this device; peer average 2.02/device2021-03: 0 reports for this device; peer average 2.13/device2021-04: 0 reports for this device; peer average 2.02/device2021-05: 0 reports for this device; peer average 1.96/device2021-06: 0 reports for this device; peer average 1.8/device2021-07: 0 reports for this device; peer average 2.05/device2021-08: 0 reports for this device; peer average 2.2/device2021-09: 0 reports for this device; peer average 1.94/device2021-10: 0 reports for this device; peer average 2.13/device2021-11: 2 reports for this device; peer average 2.1/device2021-12: 0 reports for this device; peer average 2.39/device2022-01: 0 reports for this device; peer average 2.54/device2022-02: 0 reports for this device; peer average 2.33/device2022-03: 0 reports for this device; peer average 2.38/device2022-04: 0 reports for this device; peer average 2.39/device2022-05: 0 reports for this device; peer average 2.1/device2022-06: 0 reports for this device; peer average 2.2/device2022-07: 0 reports for this device; peer average 2.23/device2022-08: 0 reports for this device; peer average 2.2/device2022-09: 0 reports for this device; peer average 2.01/device2022-10: 0 reports for this device; peer average 2.06/device2022-11: 0 reports for this device; peer average 2.07/device2022-12: 0 reports for this device; peer average 2.01/device2023-01: 0 reports for this device; peer average 1.84/device2023-02: 0 reports for this device; peer average 1.96/device2023-03: 0 reports for this device; peer average 2.05/device2023-04: 0 reports for this device; peer average 2.17/device2023-05: 0 reports for this device; peer average 2.1/device2023-06: 0 reports for this device; peer average 2.27/device2023-07: 0 reports for this device; peer average 2.05/device2023-08: 0 reports for this device; peer average 1.7/device2023-09: 0 reports for this device; peer average 1.52/device2023-10: 2 reports for this device; peer average 1.62/device2023-11: 0 reports for this device; peer average 1.63/device2023-12: 0 reports for this device; peer average 1.43/device2024-01: 0 reports for this device; peer average 1.79/device2024-02: 0 reports for this device; peer average 1.78/device2024-03: 0 reports for this device; peer average 1.66/device2024-04: 0 reports for this device; peer average 1.83/device2024-05: 0 reports for this device; peer average 1.64/device2024-06: 0 reports for this device; peer average 1.88/device2024-07: 0 reports for this device; peer average 1.56/device2024-08: 0 reports for this device; peer average 1.71/device2024-09: 0 reports for this device; peer average 1.67/device2024-10: 1 reports for this device; peer average 1.69/device2024-11: 0 reports for this device; peer average 1.58/device2024-12: 0 reports for this device; peer average 1.6/device2025-01: 0 reports for this device; peer average 1.7/device2025-02: 0 reports for this device; peer average 1.6/device2025-03: 1 reports for this device; peer average 1.88/device2025-04: 0 reports for this device; peer average 1.68/device2025-05: 1 reports for this device; peer average 1.74/device2025-06: 0 reports for this device; peer average 1.87/device2025-07: 0 reports for this device; peer average 1.74/device2025-08: 0 reports for this device; peer average 1.58/device2025-09: 0 reports for this device; peer average 1.5/device2025-10: 0 reports for this device; peer average 1.63/device2025-11: 0 reports for this device; peer average 1.75/device2025-12: 0 reports for this device; peer average 2.15/device2026-01: 0 reports for this device; peer average 1.88/device2026-02: 0 reports for this device; peer average 1.83/device2026-03: 1 reports for this device; peer average 1.74/device2026-04: 1 reports for this device; peer average 1.72/device2026-05: 0 reports for this device; peer average 1.72/device2026-06: 0 reports for this device; peer average 1.77/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.81
2019-0201.74
2019-0301.72
2019-0401.79
2019-0502.02
2019-0601.86
2019-0721.58
2019-0822.14
2019-0921.65
2019-1001.82
2019-1101.7
2019-1201.74
2020-0101.98
2020-0202.11
2020-0301.99
2020-0421.77
2020-0501.65
2020-0621.92
2020-0702.16
2020-0801.79
2020-0921.97
2020-1002.11
2020-1101.88
2020-1221.84
2021-0102.11
2021-0222.02
2021-0302.13
2021-0402.02
2021-0501.96
2021-0601.8
2021-0702.05
2021-0802.2
2021-0901.94
2021-1002.13
2021-1122.1
2021-1202.39
2022-0102.54
2022-0202.33
2022-0302.38
2022-0402.39
2022-0502.1
2022-0602.2
2022-0702.23
2022-0802.2
2022-0902.01
2022-1002.06
2022-1102.07
2022-1202.01
2023-0101.84
2023-0201.96
2023-0302.05
2023-0402.17
2023-0502.1
2023-0602.27
2023-0702.05
2023-0801.7
2023-0901.52
2023-1021.62
2023-1101.63
2023-1201.43
2024-0101.79
2024-0201.78
2024-0301.66
2024-0401.83
2024-0501.64
2024-0601.88
2024-0701.56
2024-0801.71
2024-0901.67
2024-1011.69
2024-1101.58
2024-1201.6
2025-0101.7
2025-0201.6
2025-0311.88
2025-0401.68
2025-0511.74
2025-0601.87
2025-0701.74
2025-0801.58
2025-0901.5
2025-1001.63
2025-1101.75
2025-1202.15
2026-0101.88
2026-0201.83
2026-0311.74
2026-0411.72
2026-0501.72
2026-0601.77
This device (reports/month)Average device in HSD, KWS, PHX (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K172351 — cites (transitively): K052906 (d1), K100741 (d1), K111061 (d1), K111735 (d1), K141006 (d1), K141990 (d1), K080402 (d2), K082120 (d2), K103208 (d2), K122698 (d2), K130048 (d2), K140904 (d2), K950594 (d2), K950651 (d2) — cited as predicate by K190290, K202098, K202611, K212737, K212800, K222317, K230572, K233712, K243955, K251184, K251558

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Encore Medical, L.P.

  • VAI 2021-10-28 Encore Medical, LP · 2 citations
  • NAI 2020-03-11 Encore Medical, LP · 0 citations
  • NAI 2015-07-24 Encore Medical, LP · 0 citations
  • VAI 2013-06-28 Encore Medical, LP · 2 citations