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LPS

Model 1987-25-412 · DEPUY (IRELAND) · DI 10603295079170

JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented · Class II · 21 CFR 888.3350

JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer · Class II · 21 CFR 888.3560

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 (9)

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: 9

11232019-01: 0 reports for this device; peer average 2.6/device2019-02: 0 reports for this device; peer average 2.31/device2019-03: 0 reports for this device; peer average 2.13/device2019-04: 0 reports for this device; peer average 2.33/device2019-05: 0 reports for this device; peer average 1.97/device2019-06: 0 reports for this device; peer average 2.09/device2019-07: 0 reports for this device; peer average 2.03/device2019-08: 0 reports for this device; peer average 2.19/device2019-09: 0 reports for this device; peer average 2.13/device2019-10: 0 reports for this device; peer average 2.45/device2019-11: 0 reports for this device; peer average 2.64/device2019-12: 0 reports for this device; peer average 2.39/device2020-01: 0 reports for this device; peer average 2.47/device2020-02: 0 reports for this device; peer average 2.73/device2020-03: 0 reports for this device; peer average 2.63/device2020-04: 0 reports for this device; peer average 2.18/device2020-05: 0 reports for this device; peer average 2.02/device2020-06: 0 reports for this device; peer average 2.02/device2020-07: 0 reports for this device; peer average 2.6/device2020-08: 1 reports for this device; peer average 2.45/device2020-09: 0 reports for this device; peer average 2.23/device2020-10: 0 reports for this device; peer average 2.79/device2020-11: 0 reports for this device; peer average 2.66/device2020-12: 0 reports for this device; peer average 2.75/device2021-01: 0 reports for this device; peer average 2.41/device2021-02: 0 reports for this device; peer average 2.29/device2021-03: 0 reports for this device; peer average 2.39/device2021-04: 0 reports for this device; peer average 2.26/device2021-05: 0 reports for this device; peer average 2.23/device2021-06: 0 reports for this device; peer average 2.23/device2021-07: 0 reports for this device; peer average 2.21/device2021-08: 1 reports for this device; peer average 1.89/device2021-09: 0 reports for this device; peer average 2.26/device2021-10: 1 reports for this device; peer average 1.97/device2021-11: 1 reports for this device; peer average 2.24/device2021-12: 0 reports for this device; peer average 2.32/device2022-01: 0 reports for this device; peer average 1.98/device2022-02: 0 reports for this device; peer average 2.37/device2022-03: 0 reports for this device; peer average 1.98/device2022-04: 0 reports for this device; peer average 2.11/device2022-05: 0 reports for this device; peer average 2.19/device2022-06: 0 reports for this device; peer average 2.03/device2022-07: 0 reports for this device; peer average 2.03/device2022-08: 0 reports for this device; peer average 2.09/device2022-09: 0 reports for this device; peer average 2.19/device2022-10: 0 reports for this device; peer average 2.13/device2022-11: 0 reports for this device; peer average 2.2/device2022-12: 0 reports for this device; peer average 1.93/device2023-01: 0 reports for this device; peer average 1.96/device2023-02: 0 reports for this device; peer average 2.12/device2023-03: 0 reports for this device; peer average 2.18/device2023-04: 0 reports for this device; peer average 2.16/device2023-05: 0 reports for this device; peer average 2.32/device2023-06: 0 reports for this device; peer average 2.22/device2023-07: 0 reports for this device; peer average 2.01/device2023-08: 0 reports for this device; peer average 1.81/device2023-09: 0 reports for this device; peer average 1.85/device2023-10: 0 reports for this device; peer average 1.59/device2023-11: 0 reports for this device; peer average 1.63/device2023-12: 0 reports for this device; peer average 1.66/device2024-01: 0 reports for this device; peer average 1.59/device2024-02: 0 reports for this device; peer average 1.77/device2024-03: 0 reports for this device; peer average 1.84/device2024-04: 0 reports for this device; peer average 1.65/device2024-05: 0 reports for this device; peer average 1.98/device2024-06: 0 reports for this device; peer average 1.95/device2024-07: 0 reports for this device; peer average 1.8/device2024-08: 0 reports for this device; peer average 2.17/device2024-09: 0 reports for this device; peer average 1.99/device2024-10: 0 reports for this device; peer average 1.89/device2024-11: 1 reports for this device; peer average 1.84/device2024-12: 0 reports for this device; peer average 1.91/device2025-01: 1 reports for this device; peer average 2.13/device2025-02: 0 reports for this device; peer average 1.68/device2025-03: 0 reports for this device; peer average 1.78/device2025-04: 0 reports for this device; peer average 1.68/device2025-05: 1 reports for this device; peer average 1.62/device2025-06: 0 reports for this device; peer average 1.77/device2025-07: 1 reports for this device; peer average 1.63/device2025-08: 0 reports for this device; peer average 1.58/device2025-09: 0 reports for this device; peer average 1.69/device2025-10: 0 reports for this device; peer average 1.52/device2025-11: 0 reports for this device; peer average 1.76/device2025-12: 0 reports for this device; peer average 1.72/device2026-01: 0 reports for this device; peer average 1.71/device2026-02: 0 reports for this device; peer average 1.53/device2026-03: 1 reports for this device; peer average 2.04/device2026-04: 0 reports for this device; peer average 1.76/device2026-05: 0 reports for this device; peer average 1.74/device2026-06: 0 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)
2019-0102.6
2019-0202.31
2019-0302.13
2019-0402.33
2019-0501.97
2019-0602.09
2019-0702.03
2019-0802.19
2019-0902.13
2019-1002.45
2019-1102.64
2019-1202.39
2020-0102.47
2020-0202.73
2020-0302.63
2020-0402.18
2020-0502.02
2020-0602.02
2020-0702.6
2020-0812.45
2020-0902.23
2020-1002.79
2020-1102.66
2020-1202.75
2021-0102.41
2021-0202.29
2021-0302.39
2021-0402.26
2021-0502.23
2021-0602.23
2021-0702.21
2021-0811.89
2021-0902.26
2021-1011.97
2021-1112.24
2021-1202.32
2022-0101.98
2022-0202.37
2022-0301.98
2022-0402.11
2022-0502.19
2022-0602.03
2022-0702.03
2022-0802.09
2022-0902.19
2022-1002.13
2022-1102.2
2022-1201.93
2023-0101.96
2023-0202.12
2023-0302.18
2023-0402.16
2023-0502.32
2023-0602.22
2023-0702.01
2023-0801.81
2023-0901.85
2023-1001.59
2023-1101.63
2023-1201.66
2024-0101.59
2024-0201.77
2024-0301.84
2024-0401.65
2024-0501.98
2024-0601.95
2024-0701.8
2024-0802.17
2024-0901.99
2024-1001.89
2024-1111.84
2024-1201.91
2025-0112.13
2025-0201.68
2025-0301.78
2025-0401.68
2025-0511.62
2025-0601.77
2025-0711.63
2025-0801.58
2025-0901.69
2025-1001.52
2025-1101.76
2025-1201.72
2026-0101.71
2026-0201.53
2026-0312.04
2026-0401.76
2026-0501.74
2026-0601.68
This device (reports/month)Average device in JDI, JWH (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K003182 — cited as predicate by K211677, K233980

K033959 — cited as predicate by K233980

K233980 — cites (transitively): K003182 (d1), K033959 (d1), K061648 (d1), K070267 (d1), K070849 (d1), K091453 (d1), K111433 (d1), K140881 (d1), K170806 (d1), K212746 (d1), K230295 (d1), K232303 (d1), K101433 (d2), K062654 (d2), K103756 (d2), K032151 (d2), K100391 (d2), K143393 (d2), K160700 (d2), K202194 (d2), K132624 (d2), K042871 (d3), K052888 (d3), K053340 (d3), K040166 (d3), K082500 (d3), K933785 (d3), K943462 (d3), K961685 (d3), K910500 (d3), K950010 (d3), K031729 (d3), K040267 (d3), K042883 (d3), K042993 (d3), K051146 (d3), K051380 (d3), K051977 (d3), K053514 (d3), K061521 (d3), K072221 (d3), K072575 (d3), K123166 (d3), K123486 (d3), K060515 (d3), K063633 (d3), K070095 (d3), K071417 (d3), K923807 (d3), K941769 (d3), K952830 (d3), K201347 (d3), K050539 (d4), K063423 (d4), K974556 (d4), K072160 (d4) — cited as predicate by K241000, K242665, K252887, K253197, K261458

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