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NexGen®

Model 5880-40-17 · Zimmer, Inc. · DI 00889024199323

KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer · Class II · 21 CFR 888.3510

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 (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

12452019-01: 0 reports for this device; peer average 2.1/device2019-02: 0 reports for this device; peer average 2.97/device2019-03: 0 reports for this device; peer average 1.73/device2019-04: 0 reports for this device; peer average 1.78/device2019-05: 0 reports for this device; peer average 1.79/device2019-06: 0 reports for this device; peer average 1.75/device2019-07: 0 reports for this device; peer average 2.55/device2019-08: 0 reports for this device; peer average 2.63/device2019-09: 0 reports for this device; peer average 2/device2019-10: 0 reports for this device; peer average 1.55/device2019-11: 0 reports for this device; peer average 1.56/device2019-12: 0 reports for this device; peer average 2.69/device2020-01: 0 reports for this device; peer average 2.08/device2020-02: 0 reports for this device; peer average 2.42/device2020-03: 0 reports for this device; peer average 2.7/device2020-04: 0 reports for this device; peer average 3.18/device2020-05: 0 reports for this device; peer average 4.8/device2020-06: 0 reports for this device; peer average 1.82/device2020-07: 0 reports for this device; peer average 2.11/device2020-08: 0 reports for this device; peer average 1.57/device2020-09: 0 reports for this device; peer average 2.16/device2020-10: 0 reports for this device; peer average 3.15/device2020-11: 0 reports for this device; peer average 2.29/device2020-12: 0 reports for this device; peer average 1.84/device2021-01: 0 reports for this device; peer average 1.5/device2021-02: 0 reports for this device; peer average 1.81/device2021-03: 0 reports for this device; peer average 2.21/device2021-04: 0 reports for this device; peer average 2.11/device2021-05: 0 reports for this device; peer average 2.69/device2021-06: 0 reports for this device; peer average 2.32/device2021-07: 0 reports for this device; peer average 3.29/device2021-08: 0 reports for this device; peer average 2.48/device2021-09: 0 reports for this device; peer average 3.02/device2021-10: 0 reports for this device; peer average 2.18/device2021-11: 0 reports for this device; peer average 3.38/device2021-12: 0 reports for this device; peer average 3.27/device2022-01: 0 reports for this device; peer average 2.9/device2022-02: 0 reports for this device; peer average 4.12/device2022-03: 0 reports for this device; peer average 1.79/device2022-04: 0 reports for this device; peer average 2.91/device2022-05: 0 reports for this device; peer average 2.55/device2022-06: 0 reports for this device; peer average 2.5/device2022-07: 0 reports for this device; peer average 2.18/device2022-08: 0 reports for this device; peer average 2.56/device2022-09: 0 reports for this device; peer average 2.05/device2022-10: 0 reports for this device; peer average 2.27/device2022-11: 0 reports for this device; peer average 3.06/device2022-12: 0 reports for this device; peer average 2.93/device2023-01: 0 reports for this device; peer average 1.87/device2023-02: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 2.33/device2023-04: 0 reports for this device; peer average 1.9/device2023-05: 0 reports for this device; peer average 2.82/device2023-06: 0 reports for this device; peer average 2.77/device2023-07: 0 reports for this device; peer average 2.34/device2023-08: 0 reports for this device; peer average 2.62/device2023-09: 0 reports for this device; peer average 2.78/device2023-10: 0 reports for this device; peer average 1.38/device2023-11: 0 reports for this device; peer average 1.6/device2023-12: 0 reports for this device; peer average 1.55/device2024-01: 0 reports for this device; peer average 2.13/device2024-02: 0 reports for this device; peer average 1.74/device2024-03: 0 reports for this device; peer average 1.96/device2024-04: 0 reports for this device; peer average 1.53/device2024-05: 0 reports for this device; peer average 2.38/device2024-06: 0 reports for this device; peer average 1.59/device2024-07: 0 reports for this device; peer average 1.79/device2024-08: 0 reports for this device; peer average 1.49/device2024-09: 0 reports for this device; peer average 2.93/device2024-10: 0 reports for this device; peer average 2.15/device2024-11: 1 reports for this device; peer average 1.78/device2024-12: 0 reports for this device; peer average 1.63/device2025-01: 0 reports for this device; peer average 1.53/device2025-02: 0 reports for this device; peer average 1.69/device2025-03: 0 reports for this device; peer average 1.56/device2025-04: 0 reports for this device; peer average 2.03/device2025-05: 0 reports for this device; peer average 1.92/device2025-06: 0 reports for this device; peer average 1.9/device2025-07: 0 reports for this device; peer average 1.87/device2025-08: 0 reports for this device; peer average 2.33/device2025-09: 0 reports for this device; peer average 2.33/device2025-10: 0 reports for this device; peer average 1.96/device2025-11: 0 reports for this device; peer average 2.64/device2025-12: 0 reports for this device; peer average 2.4/device2026-01: 0 reports for this device; peer average 3.33/device2026-02: 0 reports for this device; peer average 2.24/device2026-03: 0 reports for this device; peer average 3.04/device2026-04: 0 reports for this device; peer average 1.72/device2026-05: 0 reports for this device; peer average 2.57/device2026-06: 0 reports for this device; peer average 1.67/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.1
2019-0202.97
2019-0301.73
2019-0401.78
2019-0501.79
2019-0601.75
2019-0702.55
2019-0802.63
2019-0902
2019-1001.55
2019-1101.56
2019-1202.69
2020-0102.08
2020-0202.42
2020-0302.7
2020-0403.18
2020-0504.8
2020-0601.82
2020-0702.11
2020-0801.57
2020-0902.16
2020-1003.15
2020-1102.29
2020-1201.84
2021-0101.5
2021-0201.81
2021-0302.21
2021-0402.11
2021-0502.69
2021-0602.32
2021-0703.29
2021-0802.48
2021-0903.02
2021-1002.18
2021-1103.38
2021-1203.27
2022-0102.9
2022-0204.12
2022-0301.79
2022-0402.91
2022-0502.55
2022-0602.5
2022-0702.18
2022-0802.56
2022-0902.05
2022-1002.27
2022-1103.06
2022-1202.93
2023-0101.87
2023-0202
2023-0302.33
2023-0401.9
2023-0502.82
2023-0602.77
2023-0702.34
2023-0802.62
2023-0902.78
2023-1001.38
2023-1101.6
2023-1201.55
2024-0102.13
2024-0201.74
2024-0301.96
2024-0401.53
2024-0502.38
2024-0601.59
2024-0701.79
2024-0801.49
2024-0902.93
2024-1002.15
2024-1111.78
2024-1201.63
2025-0101.53
2025-0201.69
2025-0301.56
2025-0402.03
2025-0501.92
2025-0601.9
2025-0701.87
2025-0802.33
2025-0902.33
2025-1001.96
2025-1102.64
2025-1202.4
2026-0103.33
2026-0202.24
2026-0303.04
2026-0401.72
2026-0502.57
2026-0601.67
This device (reports/month)Average device in KRO (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K013385 — cited as predicate by K101815, K110940, K143179, K152494, K173057, K190100

K173057 — cites (transitively): K002335 (d1), K003910 (d1), K013031 (d1), K013385 (d1), K023211 (d1), K023528 (d1), K031061 (d1), K031183 (d1), K041100 (d1), K042271 (d1), K043101 (d1), K052879 (d1), K060370 (d1), K062768 (d1), K070214 (d1), K070695 (d1), K072160 (d1), K072281 (d1), K072619 (d1), K152494 (d1), K872379 (d1), K892800 (d1), K931651 (d1), K933785 (d1), K935789 (d1), K936159 (d1), K946150 (d1), K951185 (d1), K960279 (d1), K963148 (d1), K970498 (d1), K972501 (d1), K973412 (d1), K982903 (d1), K983153 (d1), K991581 (d1) — cited as predicate by K181947, K191625

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

Manufacturer compliance record — Zimmer, Inc.

  • Warning Letter 2016-05-27 Orthosoft, Inc.
  • Warning Letter 2012-09-19 Zimmer Manufacturing B.V.
  • NAI 2022-07-27 Zimmer, Inc. · 0 citations
  • NAI 2022-07-27 Zimmer, Inc. · 0 citations
  • NAI 2020-10-01 Zimmer Manufacturing B.V. · 0 citations
  • VAI 2017-10-16 Zimmer, Inc. · 8 citations
  • VAI 2017-10-16 Zimmer, Inc. · 8 citations
  • NAI 2017-09-01 Zimmer Trabecular Metal Technology, Inc. · 0 citations
  • VAI 2017-07-27 ZIMMER ORTHOPEDIC MFG LTD · 3 citations
  • VAI 2017-07-20 Zimmer Manufacturing B.V. · 3 citations
  • VAI 2016-05-23 Zimmer Surgical Inc · 4 citations
  • OAI 2015-11-20 Zimmer, Inc. · 10 citations
  • OAI 2015-11-20 Zimmer, Inc. · 10 citations
  • VAI 2015-11-17 Zimmer Manufacturing B.V. · 4 citations
  • VAI 2015-05-11 Zimmer Trabecular Metal Technology, Inc. · 3 citations
  • VAI 2014-10-16 ZIMMER ORTHOPEDIC MFG LTD · 2 citations
  • OAI 2014-06-11 Zimmer Manufacturing B.V. · 9 citations
  • OAI 2014-05-28 Zimmer, Inc. · 12 citations
  • OAI 2014-05-28 Zimmer, Inc. · 12 citations
  • VAI 2014-02-07 Zimmer, Inc. · 2 citations
  • VAI 2014-02-07 Zimmer, Inc. · 2 citations
  • OAI 2013-08-19 Zimmer, Inc. · 0 citations