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Trabecular Metal®

Model 00-4309-023-16 · Zimmer, Inc. · DI 00889024267268

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

KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3650

UDILibrary device dossier · generated 2026-09-06 · 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.

11222019-01: 0 reports for this device; peer average 1.75/device2019-02: 0 reports for this device; peer average 1.53/device2019-03: 0 reports for this device; peer average 1.61/device2019-04: 0 reports for this device; peer average 1.66/device2019-05: 0 reports for this device; peer average 1.84/device2019-06: 0 reports for this device; peer average 1.85/device2019-07: 0 reports for this device; peer average 1.42/device2019-08: 0 reports for this device; peer average 2.01/device2019-09: 0 reports for this device; peer average 1.53/device2019-10: 0 reports for this device; peer average 1.8/device2019-11: 0 reports for this device; peer average 1.6/device2019-12: 0 reports for this device; peer average 1.76/device2020-01: 0 reports for this device; peer average 1.93/device2020-02: 0 reports for this device; peer average 2.15/device2020-03: 0 reports for this device; peer average 1.66/device2020-04: 0 reports for this device; peer average 1.67/device2020-05: 0 reports for this device; peer average 1.58/device2020-06: 0 reports for this device; peer average 1.94/device2020-07: 0 reports for this device; peer average 1.93/device2020-08: 0 reports for this device; peer average 1.82/device2020-09: 0 reports for this device; peer average 2/device2020-10: 0 reports for this device; peer average 2.08/device2020-11: 0 reports for this device; peer average 1.89/device2020-12: 0 reports for this device; peer average 1.81/device2021-01: 0 reports for this device; peer average 1.94/device2021-02: 0 reports for this device; peer average 1.85/device2021-03: 0 reports for this device; peer average 1.98/device2021-04: 0 reports for this device; peer average 1.89/device2021-05: 0 reports for this device; peer average 1.71/device2021-06: 0 reports for this device; peer average 1.56/device2021-07: 0 reports for this device; peer average 1.99/device2021-08: 0 reports for this device; peer average 2.16/device2021-09: 0 reports for this device; peer average 1.76/device2021-10: 0 reports for this device; peer average 1.88/device2021-11: 0 reports for this device; peer average 1.96/device2021-12: 0 reports for this device; peer average 1.99/device2022-01: 0 reports for this device; peer average 2.16/device2022-02: 0 reports for this device; peer average 2.19/device2022-03: 0 reports for this device; peer average 1.87/device2022-04: 0 reports for this device; peer average 2.09/device2022-05: 0 reports for this device; peer average 1.89/device2022-06: 0 reports for this device; peer average 2.15/device2022-07: 0 reports for this device; peer average 2.17/device2022-08: 0 reports for this device; peer average 2/device2022-09: 0 reports for this device; peer average 1.89/device2022-10: 0 reports for this device; peer average 1.83/device2022-11: 0 reports for this device; peer average 1.93/device2022-12: 0 reports for this device; peer average 1.83/device2023-01: 0 reports for this device; peer average 1.74/device2023-02: 0 reports for this device; peer average 1.81/device2023-03: 0 reports for this device; peer average 1.89/device2023-04: 0 reports for this device; peer average 1.89/device2023-05: 0 reports for this device; peer average 1.95/device2023-06: 0 reports for this device; peer average 2.13/device2023-07: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 1.62/device2023-09: 0 reports for this device; peer average 1.45/device2023-10: 0 reports for this device; peer average 1.55/device2023-11: 0 reports for this device; peer average 1.58/device2023-12: 0 reports for this device; peer average 1.38/device2024-01: 0 reports for this device; peer average 1.77/device2024-02: 0 reports for this device; peer average 1.7/device2024-03: 0 reports for this device; peer average 1.6/device2024-04: 0 reports for this device; peer average 1.77/device2024-05: 0 reports for this device; peer average 1.61/device2024-06: 0 reports for this device; peer average 1.88/device2024-07: 0 reports for this device; peer average 1.52/device2024-08: 0 reports for this device; peer average 1.67/device2024-09: 0 reports for this device; peer average 1.65/device2024-10: 0 reports for this device; peer average 1.63/device2024-11: 0 reports for this device; peer average 1.58/device2024-12: 0 reports for this device; peer average 1.62/device2025-01: 0 reports for this device; peer average 1.69/device2025-02: 0 reports for this device; peer average 1.57/device2025-03: 0 reports for this device; peer average 1.78/device2025-04: 0 reports for this device; peer average 1.7/device2025-05: 0 reports for this device; peer average 1.76/device2025-06: 0 reports for this device; peer average 1.78/device2025-07: 0 reports for this device; peer average 1.63/device2025-08: 0 reports for this device; peer average 1.6/device2025-09: 0 reports for this device; peer average 1.45/device2025-10: 0 reports for this device; peer average 1.56/device2025-11: 0 reports for this device; peer average 1.74/device2025-12: 0 reports for this device; peer average 2.07/device2026-01: 0 reports for this device; peer average 1.8/device2026-02: 0 reports for this device; peer average 1.73/device2026-03: 0 reports for this device; peer average 1.67/device2026-04: 0 reports for this device; peer average 1.7/device2026-05: 0 reports for this device; peer average 1.64/device2026-06: 0 reports for this device; peer average 1.65/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.75
2019-0201.53
2019-0301.61
2019-0401.66
2019-0501.84
2019-0601.85
2019-0701.42
2019-0802.01
2019-0901.53
2019-1001.8
2019-1101.6
2019-1201.76
2020-0101.93
2020-0202.15
2020-0301.66
2020-0401.67
2020-0501.58
2020-0601.94
2020-0701.93
2020-0801.82
2020-0902
2020-1002.08
2020-1101.89
2020-1201.81
2021-0101.94
2021-0201.85
2021-0301.98
2021-0401.89
2021-0501.71
2021-0601.56
2021-0701.99
2021-0802.16
2021-0901.76
2021-1001.88
2021-1101.96
2021-1201.99
2022-0102.16
2022-0202.19
2022-0301.87
2022-0402.09
2022-0501.89
2022-0602.15
2022-0702.17
2022-0802
2022-0901.89
2022-1001.83
2022-1101.93
2022-1201.83
2023-0101.74
2023-0201.81
2023-0301.89
2023-0401.89
2023-0501.95
2023-0602.13
2023-0702
2023-0801.62
2023-0901.45
2023-1001.55
2023-1101.58
2023-1201.38
2024-0101.77
2024-0201.7
2024-0301.6
2024-0401.77
2024-0501.61
2024-0601.88
2024-0701.52
2024-0801.67
2024-0901.65
2024-1001.63
2024-1101.58
2024-1201.62
2025-0101.69
2025-0201.57
2025-0301.78
2025-0401.7
2025-0501.76
2025-0601.78
2025-0701.63
2025-0801.6
2025-0901.45
2025-1001.56
2025-1101.74
2025-1202.07
2026-0101.8
2026-0201.73
2026-0301.67
2026-0401.7
2026-0501.64
2026-0601.65
This device (reports/month)Average device in HSD, KWS, KWT (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K121543 — cited as predicate by K172767, K173411, K220847

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