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P.F.C. SIGMA

Model 96-2741 · DEPUY (IRELAND) · DI 10603295244226

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

UDILibrary device dossier · generated 2026-09-14 · 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 (1)

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: 1

12232019-01: 0 reports for this device; peer average 2.03/device2019-02: 0 reports for this device; peer average 2.07/device2019-03: 0 reports for this device; peer average 1.68/device2019-04: 0 reports for this device; peer average 2.01/device2019-05: 0 reports for this device; peer average 1.83/device2019-06: 0 reports for this device; peer average 2.19/device2019-07: 0 reports for this device; peer average 2.04/device2019-08: 0 reports for this device; peer average 2.24/device2019-09: 0 reports for this device; peer average 2.01/device2019-10: 0 reports for this device; peer average 2.44/device2019-11: 0 reports for this device; peer average 3.01/device2019-12: 0 reports for this device; peer average 2.42/device2020-01: 0 reports for this device; peer average 2.39/device2020-02: 0 reports for this device; peer average 2.82/device2020-03: 0 reports for this device; peer average 2.28/device2020-04: 0 reports for this device; peer average 2.21/device2020-05: 0 reports for this device; peer average 1.83/device2020-06: 0 reports for this device; peer average 2.09/device2020-07: 0 reports for this device; peer average 2.66/device2020-08: 0 reports for this device; peer average 2.72/device2020-09: 0 reports for this device; peer average 2.23/device2020-10: 0 reports for this device; peer average 2.94/device2020-11: 0 reports for this device; peer average 2.86/device2020-12: 0 reports for this device; peer average 2.95/device2021-01: 0 reports for this device; peer average 2.47/device2021-02: 0 reports for this device; peer average 2.45/device2021-03: 0 reports for this device; peer average 2.59/device2021-04: 0 reports for this device; peer average 2.45/device2021-05: 0 reports for this device; peer average 2.36/device2021-06: 0 reports for this device; peer average 2.18/device2021-07: 0 reports for this device; peer average 2.24/device2021-08: 0 reports for this device; peer average 1.88/device2021-09: 0 reports for this device; peer average 2.33/device2021-10: 0 reports for this device; peer average 1.96/device2021-11: 0 reports for this device; peer average 2.31/device2021-12: 0 reports for this device; peer average 2.33/device2022-01: 0 reports for this device; peer average 2.03/device2022-02: 0 reports for this device; peer average 2.38/device2022-03: 0 reports for this device; peer average 2.05/device2022-04: 0 reports for this device; peer average 2.1/device2022-05: 0 reports for this device; peer average 2.33/device2022-06: 0 reports for this device; peer average 2.03/device2022-07: 0 reports for this device; peer average 2.06/device2022-08: 1 reports for this device; peer average 2.1/device2022-09: 0 reports for this device; peer average 2.28/device2022-10: 0 reports for this device; peer average 2.2/device2022-11: 0 reports for this device; peer average 2.24/device2022-12: 0 reports for this device; peer average 1.9/device2023-01: 0 reports for this device; peer average 2.09/device2023-02: 0 reports for this device; peer average 2.23/device2023-03: 0 reports for this device; peer average 2.23/device2023-04: 0 reports for this device; peer average 2.26/device2023-05: 0 reports for this device; peer average 2.41/device2023-06: 0 reports for this device; peer average 2.26/device2023-07: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 1.71/device2023-09: 0 reports for this device; peer average 1.76/device2023-10: 0 reports for this device; peer average 1.63/device2023-11: 0 reports for this device; peer average 1.68/device2023-12: 0 reports for this device; peer average 1.7/device2024-01: 0 reports for this device; peer average 1.57/device2024-02: 0 reports for this device; peer average 1.74/device2024-03: 0 reports for this device; peer average 1.78/device2024-04: 0 reports for this device; peer average 1.64/device2024-05: 0 reports for this device; peer average 1.91/device2024-06: 0 reports for this device; peer average 1.98/device2024-07: 0 reports for this device; peer average 1.85/device2024-08: 0 reports for this device; peer average 2.31/device2024-09: 0 reports for this device; peer average 2/device2024-10: 0 reports for this device; peer average 1.99/device2024-11: 0 reports for this device; peer average 2/device2024-12: 0 reports for this device; peer average 2.09/device2025-01: 0 reports for this device; peer average 2.32/device2025-02: 0 reports for this device; peer average 1.83/device2025-03: 0 reports for this device; peer average 1.86/device2025-04: 0 reports for this device; peer average 1.66/device2025-05: 0 reports for this device; peer average 1.71/device2025-06: 0 reports for this device; peer average 1.81/device2025-07: 0 reports for this device; peer average 1.62/device2025-08: 0 reports for this device; peer average 1.63/device2025-09: 0 reports for this device; peer average 1.64/device2025-10: 0 reports for this device; peer average 1.43/device2025-11: 0 reports for this device; peer average 1.7/device2025-12: 0 reports for this device; peer average 1.66/device2026-01: 0 reports for this device; peer average 1.55/device2026-02: 0 reports for this device; peer average 1.53/device2026-03: 0 reports for this device; peer average 1.99/device2026-04: 0 reports for this device; peer average 1.75/device2026-05: 0 reports for this device; peer average 1.71/device2026-06: 0 reports for this device; peer average 1.7/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.03
2019-0202.07
2019-0301.68
2019-0402.01
2019-0501.83
2019-0602.19
2019-0702.04
2019-0802.24
2019-0902.01
2019-1002.44
2019-1103.01
2019-1202.42
2020-0102.39
2020-0202.82
2020-0302.28
2020-0402.21
2020-0501.83
2020-0602.09
2020-0702.66
2020-0802.72
2020-0902.23
2020-1002.94
2020-1102.86
2020-1202.95
2021-0102.47
2021-0202.45
2021-0302.59
2021-0402.45
2021-0502.36
2021-0602.18
2021-0702.24
2021-0801.88
2021-0902.33
2021-1001.96
2021-1102.31
2021-1202.33
2022-0102.03
2022-0202.38
2022-0302.05
2022-0402.1
2022-0502.33
2022-0602.03
2022-0702.06
2022-0812.1
2022-0902.28
2022-1002.2
2022-1102.24
2022-1201.9
2023-0102.09
2023-0202.23
2023-0302.23
2023-0402.26
2023-0502.41
2023-0602.26
2023-0702
2023-0801.71
2023-0901.76
2023-1001.63
2023-1101.68
2023-1201.7
2024-0101.57
2024-0201.74
2024-0301.78
2024-0401.64
2024-0501.91
2024-0601.98
2024-0701.85
2024-0802.31
2024-0902
2024-1001.99
2024-1102
2024-1202.09
2025-0102.32
2025-0201.83
2025-0301.86
2025-0401.66
2025-0501.71
2025-0601.81
2025-0701.62
2025-0801.63
2025-0901.64
2025-1001.43
2025-1101.7
2025-1201.66
2026-0101.55
2026-0201.53
2026-0301.99
2026-0401.75
2026-0501.71
2026-0601.7
This device (reports/month)Average device in JWH (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K241000 — cites (transitively): K032151 (d1), K033272 (d1), K040166 (d1), K060515 (d1), K062654 (d1), K063633 (d1), K073529 (d1), K160700 (d1), K212746 (d1), K230295 (d1), K232303 (d1), K233980 (d1), K870730 (d1), K882234 (d1), K884796 (d1), K896048 (d1), K905810 (d1), K923807 (d1), K924940 (d1), K936037 (d1), K943462 (d1), K950010 (d1), K952830 (d1), K961685 (d1), K963117 (d1), K971189 (d1), K971652 (d1), K984158 (d1), K070095 (d2), K071417 (d2), K101433 (d2), K111433 (d2), K941769 (d2), K100391 (d2), K143393 (d2), K202194 (d2), K132624 (d2), K003182 (d2), K033959 (d2), K061648 (d2), K070267 (d2), K070849 (d2), K091453 (d2), K140881 (d2), K170806 (d2), K042871 (d3), K052888 (d3), K053340 (d3), K082500 (d3), K933785 (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), K103756 (d3), K201347 (d3), K910500 (d4), K050539 (d4), K063423 (d4), K974556 (d4), K072160 (d4) — cited as predicate by K253197

K950010 — cited as predicate by K102578, K103756, K150496, K182301, K241000

K952830 — cited as predicate by K112891, K160700, K182301, K201023, K241000

K963117 — cited as predicate by K241000

K971189 — cited as predicate by K122975, K182301, K241000

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