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DELTA XTEND

Model 130738203 · DEPUY (IRELAND) · DI 10603295027362

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

UDILibrary device dossier · generated 2026-09-13 · 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 (145)

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: 135 · Malfunction: 10

23562019-01: 5 reports for this device; peer average 1.71/device2019-02: 5 reports for this device; peer average 1.54/device2019-03: 5 reports for this device; peer average 1.66/device2019-04: 0 reports for this device; peer average 1.53/device2019-05: 2 reports for this device; peer average 1.78/device2019-06: 3 reports for this device; peer average 1.84/device2019-07: 1 reports for this device; peer average 1.38/device2019-08: 2 reports for this device; peer average 1.99/device2019-09: 2 reports for this device; peer average 1.51/device2019-10: 1 reports for this device; peer average 1.76/device2019-11: 3 reports for this device; peer average 1.63/device2019-12: 3 reports for this device; peer average 1.72/device2020-01: 1 reports for this device; peer average 1.95/device2020-02: 2 reports for this device; peer average 2.16/device2020-03: 1 reports for this device; peer average 1.64/device2020-04: 0 reports for this device; peer average 1.7/device2020-05: 1 reports for this device; peer average 1.51/device2020-06: 3 reports for this device; peer average 1.83/device2020-07: 3 reports for this device; peer average 1.94/device2020-08: 3 reports for this device; peer average 1.73/device2020-09: 1 reports for this device; peer average 1.95/device2020-10: 4 reports for this device; peer average 2/device2020-11: 0 reports for this device; peer average 1.83/device2020-12: 2 reports for this device; peer average 1.79/device2021-01: 0 reports for this device; peer average 1.93/device2021-02: 0 reports for this device; peer average 1.92/device2021-03: 6 reports for this device; peer average 2.02/device2021-04: 1 reports for this device; peer average 1.87/device2021-05: 1 reports for this device; peer average 1.78/device2021-06: 0 reports for this device; peer average 1.58/device2021-07: 2 reports for this device; peer average 1.92/device2021-08: 1 reports for this device; peer average 2.1/device2021-09: 0 reports for this device; peer average 1.74/device2021-10: 1 reports for this device; peer average 1.82/device2021-11: 3 reports for this device; peer average 1.99/device2021-12: 2 reports for this device; peer average 1.92/device2022-01: 1 reports for this device; peer average 2.14/device2022-02: 0 reports for this device; peer average 2.1/device2022-03: 0 reports for this device; peer average 1.77/device2022-04: 1 reports for this device; peer average 2.07/device2022-05: 4 reports for this device; peer average 1.93/device2022-06: 1 reports for this device; peer average 2.03/device2022-07: 2 reports for this device; peer average 2.15/device2022-08: 2 reports for this device; peer average 1.98/device2022-09: 1 reports for this device; peer average 1.88/device2022-10: 3 reports for this device; peer average 1.87/device2022-11: 2 reports for this device; peer average 1.93/device2022-12: 3 reports for this device; peer average 1.81/device2023-01: 2 reports for this device; peer average 1.75/device2023-02: 0 reports for this device; peer average 1.83/device2023-03: 0 reports for this device; peer average 1.96/device2023-04: 1 reports for this device; peer average 1.94/device2023-05: 2 reports for this device; peer average 2.01/device2023-06: 1 reports for this device; peer average 2.21/device2023-07: 0 reports for this device; peer average 2/device2023-08: 1 reports for this device; peer average 1.61/device2023-09: 1 reports for this device; peer average 1.44/device2023-10: 1 reports for this device; peer average 1.57/device2023-11: 2 reports for this device; peer average 1.56/device2023-12: 1 reports for this device; peer average 1.39/device2024-01: 2 reports for this device; peer average 1.81/device2024-02: 1 reports for this device; peer average 1.64/device2024-03: 1 reports for this device; peer average 1.59/device2024-04: 2 reports for this device; peer average 1.74/device2024-05: 0 reports for this device; peer average 1.59/device2024-06: 1 reports for this device; peer average 1.88/device2024-07: 1 reports for this device; peer average 1.5/device2024-08: 2 reports for this device; peer average 1.68/device2024-09: 0 reports for this device; peer average 1.61/device2024-10: 3 reports for this device; peer average 1.59/device2024-11: 0 reports for this device; peer average 1.51/device2024-12: 2 reports for this device; peer average 1.55/device2025-01: 2 reports for this device; peer average 1.67/device2025-02: 3 reports for this device; peer average 1.52/device2025-03: 2 reports for this device; peer average 1.78/device2025-04: 0 reports for this device; peer average 1.58/device2025-05: 2 reports for this device; peer average 1.66/device2025-06: 2 reports for this device; peer average 1.76/device2025-07: 2 reports for this device; peer average 1.66/device2025-08: 2 reports for this device; peer average 1.51/device2025-09: 0 reports for this device; peer average 1.48/device2025-10: 2 reports for this device; peer average 1.56/device2025-11: 1 reports for this device; peer average 1.74/device2025-12: 2 reports for this device; peer average 2.08/device2026-01: 3 reports for this device; peer average 1.81/device2026-02: 0 reports for this device; peer average 1.79/device2026-03: 0 reports for this device; peer average 1.66/device2026-04: 2 reports for this device; peer average 1.69/device2026-05: 2 reports for this device; peer average 1.65/device2026-06: 1 reports for this device; peer average 1.68/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0151.71
2019-0251.54
2019-0351.66
2019-0401.53
2019-0521.78
2019-0631.84
2019-0711.38
2019-0821.99
2019-0921.51
2019-1011.76
2019-1131.63
2019-1231.72
2020-0111.95
2020-0222.16
2020-0311.64
2020-0401.7
2020-0511.51
2020-0631.83
2020-0731.94
2020-0831.73
2020-0911.95
2020-1042
2020-1101.83
2020-1221.79
2021-0101.93
2021-0201.92
2021-0362.02
2021-0411.87
2021-0511.78
2021-0601.58
2021-0721.92
2021-0812.1
2021-0901.74
2021-1011.82
2021-1131.99
2021-1221.92
2022-0112.14
2022-0202.1
2022-0301.77
2022-0412.07
2022-0541.93
2022-0612.03
2022-0722.15
2022-0821.98
2022-0911.88
2022-1031.87
2022-1121.93
2022-1231.81
2023-0121.75
2023-0201.83
2023-0301.96
2023-0411.94
2023-0522.01
2023-0612.21
2023-0702
2023-0811.61
2023-0911.44
2023-1011.57
2023-1121.56
2023-1211.39
2024-0121.81
2024-0211.64
2024-0311.59
2024-0421.74
2024-0501.59
2024-0611.88
2024-0711.5
2024-0821.68
2024-0901.61
2024-1031.59
2024-1101.51
2024-1221.55
2025-0121.67
2025-0231.52
2025-0321.78
2025-0401.58
2025-0521.66
2025-0621.76
2025-0721.66
2025-0821.51
2025-0901.48
2025-1021.56
2025-1111.74
2025-1222.08
2026-0131.81
2026-0201.79
2026-0301.66
2026-0421.69
2026-0521.65
2026-0611.68
This device (reports/month)Average device in HSD, KWS (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K062250 — cited as predicate by K170452, K170748, K170893, K172054, K183077, K190286, K192448, K193394, K193560, K210167, K212569, K212737, K220452, K230315, K231112, K233408, K241143, K242813, K250338, K260802

K081620 — cited as predicate by K212737

K120174 — cited as predicate by K170893, K172054, K183077, K190286, K192448, K192855, K193560, K203694, K210167, K210207, K212569, K212737, K220452, K230315, K231112, K233408, K241143, K242813, K260802

K192855 — cites (transitively): K071379 (d1), K120174 (d1), K122698 (d1), K170748 (d1), K052906 (d2), K060704 (d2), K062250 (d2), K101996 (d2), K133834 (d2) — cited as predicate by K203694, K211553

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

Manufacturer compliance record — DEPUY (IRELAND)

  • NAI 2024-07-04 DEPUY (IRELAND) · 0 citations
  • NAI 2015-01-08 DEPUY (IRELAND) · 0 citations
  • VAI 2012-01-26 DEPUY (IRELAND) · 1 citations
  • NAI 2011-02-03 DEPUY (IRELAND) · 0 citations