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Unnamed device

Model 5842-25-10 · Zimmer, Inc. · DI 00889024633780

HSX — Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer · Class II · 21 CFR 888.3520

UDILibrary device dossier · generated 2026-09-12 · 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 (0)

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.

13462019-01: 0 reports for this device; peer average 1.68/device2019-02: 0 reports for this device; peer average 1.71/device2019-03: 0 reports for this device; peer average 1.57/device2019-04: 0 reports for this device; peer average 1.9/device2019-05: 0 reports for this device; peer average 1.77/device2019-06: 0 reports for this device; peer average 1.78/device2019-07: 0 reports for this device; peer average 1.44/device2019-08: 0 reports for this device; peer average 1.67/device2019-09: 0 reports for this device; peer average 1.79/device2019-10: 0 reports for this device; peer average 1.84/device2019-11: 0 reports for this device; peer average 1.25/device2019-12: 0 reports for this device; peer average 2/device2020-01: 0 reports for this device; peer average 1.33/device2020-02: 0 reports for this device; peer average 2.07/device2020-03: 0 reports for this device; peer average 2.73/device2020-04: 0 reports for this device; peer average 1.43/device2020-05: 0 reports for this device; peer average 1.22/device2020-06: 0 reports for this device; peer average 2.65/device2020-07: 0 reports for this device; peer average 2.32/device2020-08: 0 reports for this device; peer average 2.84/device2020-09: 0 reports for this device; peer average 1.82/device2020-10: 0 reports for this device; peer average 1.79/device2020-11: 0 reports for this device; peer average 2.82/device2020-12: 0 reports for this device; peer average 2.14/device2021-01: 0 reports for this device; peer average 2.13/device2021-02: 0 reports for this device; peer average 2.44/device2021-03: 0 reports for this device; peer average 2.1/device2021-04: 0 reports for this device; peer average 2.7/device2021-05: 0 reports for this device; peer average 2/device2021-06: 0 reports for this device; peer average 2.92/device2021-07: 0 reports for this device; peer average 3/device2021-08: 0 reports for this device; peer average 2.19/device2021-09: 0 reports for this device; peer average 2.68/device2021-10: 0 reports for this device; peer average 3.73/device2021-11: 0 reports for this device; peer average 2.31/device2021-12: 0 reports for this device; peer average 2.88/device2022-01: 0 reports for this device; peer average 1.82/device2022-02: 0 reports for this device; peer average 2.21/device2022-03: 0 reports for this device; peer average 2.9/device2022-04: 0 reports for this device; peer average 2.47/device2022-05: 0 reports for this device; peer average 2.4/device2022-06: 0 reports for this device; peer average 2.3/device2022-07: 0 reports for this device; peer average 2.82/device2022-08: 0 reports for this device; peer average 2.06/device2022-09: 0 reports for this device; peer average 5.83/device2022-10: 0 reports for this device; peer average 2.15/device2022-11: 0 reports for this device; peer average 2/device2022-12: 0 reports for this device; peer average 2/device2023-01: 0 reports for this device; peer average 2.5/device2023-02: 0 reports for this device; peer average 2.67/device2023-03: 0 reports for this device; peer average 2.44/device2023-04: 0 reports for this device; peer average 2/device2023-05: 0 reports for this device; peer average 2.59/device2023-06: 0 reports for this device; peer average 3.19/device2023-07: 0 reports for this device; peer average 2.22/device2023-08: 0 reports for this device; peer average 2.39/device2023-09: 0 reports for this device; peer average 1.5/device2023-10: 0 reports for this device; peer average 1.84/device2023-11: 0 reports for this device; peer average 2.12/device2023-12: 0 reports for this device; peer average 1.62/device2024-01: 0 reports for this device; peer average 2.67/device2024-02: 0 reports for this device; peer average 1.64/device2024-03: 0 reports for this device; peer average 1.91/device2024-04: 0 reports for this device; peer average 2.06/device2024-05: 0 reports for this device; peer average 1.77/device2024-06: 0 reports for this device; peer average 1.63/device2024-07: 0 reports for this device; peer average 2/device2024-08: 0 reports for this device; peer average 1.43/device2024-09: 0 reports for this device; peer average 1.56/device2024-10: 0 reports for this device; peer average 1.84/device2024-11: 0 reports for this device; peer average 1.61/device2024-12: 0 reports for this device; peer average 2/device2025-01: 0 reports for this device; peer average 1.78/device2025-02: 0 reports for this device; peer average 1.62/device2025-03: 0 reports for this device; peer average 1.75/device2025-04: 0 reports for this device; peer average 1.58/device2025-05: 0 reports for this device; peer average 1.54/device2025-06: 0 reports for this device; peer average 1.71/device2025-07: 0 reports for this device; peer average 2.19/device2025-08: 0 reports for this device; peer average 2/device2025-09: 0 reports for this device; peer average 1.67/device2025-10: 0 reports for this device; peer average 1.83/device2025-11: 0 reports for this device; peer average 1.73/device2025-12: 0 reports for this device; peer average 1.61/device2026-01: 0 reports for this device; peer average 1.89/device2026-02: 0 reports for this device; peer average 1.9/device2026-03: 0 reports for this device; peer average 2.28/device2026-04: 0 reports for this device; peer average 1.69/device2026-05: 0 reports for this device; peer average 2.13/device2026-06: 0 reports for this device; peer average 2.29/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.68
2019-0201.71
2019-0301.57
2019-0401.9
2019-0501.77
2019-0601.78
2019-0701.44
2019-0801.67
2019-0901.79
2019-1001.84
2019-1101.25
2019-1202
2020-0101.33
2020-0202.07
2020-0302.73
2020-0401.43
2020-0501.22
2020-0602.65
2020-0702.32
2020-0802.84
2020-0901.82
2020-1001.79
2020-1102.82
2020-1202.14
2021-0102.13
2021-0202.44
2021-0302.1
2021-0402.7
2021-0502
2021-0602.92
2021-0703
2021-0802.19
2021-0902.68
2021-1003.73
2021-1102.31
2021-1202.88
2022-0101.82
2022-0202.21
2022-0302.9
2022-0402.47
2022-0502.4
2022-0602.3
2022-0702.82
2022-0802.06
2022-0905.83
2022-1002.15
2022-1102
2022-1202
2023-0102.5
2023-0202.67
2023-0302.44
2023-0402
2023-0502.59
2023-0603.19
2023-0702.22
2023-0802.39
2023-0901.5
2023-1001.84
2023-1102.12
2023-1201.62
2024-0102.67
2024-0201.64
2024-0301.91
2024-0402.06
2024-0501.77
2024-0601.63
2024-0702
2024-0801.43
2024-0901.56
2024-1001.84
2024-1101.61
2024-1202
2025-0101.78
2025-0201.62
2025-0301.75
2025-0401.58
2025-0501.54
2025-0601.71
2025-0702.19
2025-0802
2025-0901.67
2025-1001.83
2025-1101.73
2025-1201.61
2026-0101.89
2026-0201.9
2026-0302.28
2026-0401.69
2026-0502.13
2026-0602.29
This device (reports/month)Average device in HSX (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K033363 — cited as predicate by K112301, K121974, K122529, K123380, K161592, K161741, K162084, K163700, K183029, K190439, K191150, K191325, K191996, K203341, K211221, K211471, K212307, K230653, K241260

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