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TM

Model 82-0180-124-00 · Zimmer, Inc. · DI 00889024504479

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

PHX — Shoulder Prosthesis, Reverse Configuration · Class II · 21 CFR 888.3660

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.

11232019-01: 0 reports for this device; peer average 1.82/device2019-02: 0 reports for this device; peer average 1.71/device2019-03: 0 reports for this device; peer average 1.67/device2019-04: 0 reports for this device; peer average 1.86/device2019-05: 0 reports for this device; peer average 2.04/device2019-06: 0 reports for this device; peer average 1.86/device2019-07: 0 reports for this device; peer average 1.6/device2019-08: 0 reports for this device; peer average 2.14/device2019-09: 0 reports for this device; peer average 1.65/device2019-10: 0 reports for this device; peer average 1.85/device2019-11: 0 reports for this device; peer average 1.67/device2019-12: 0 reports for this device; peer average 1.77/device2020-01: 0 reports for this device; peer average 1.96/device2020-02: 0 reports for this device; peer average 2.1/device2020-03: 0 reports for this device; peer average 1.99/device2020-04: 0 reports for this device; peer average 1.73/device2020-05: 0 reports for this device; peer average 1.69/device2020-06: 0 reports for this device; peer average 1.99/device2020-07: 0 reports for this device; peer average 2.14/device2020-08: 0 reports for this device; peer average 1.84/device2020-09: 0 reports for this device; peer average 2.01/device2020-10: 0 reports for this device; peer average 2.16/device2020-11: 0 reports for this device; peer average 1.91/device2020-12: 0 reports for this device; peer average 1.85/device2021-01: 0 reports for this device; peer average 2.1/device2021-02: 0 reports for this device; peer average 1.95/device2021-03: 0 reports for this device; peer average 2.09/device2021-04: 0 reports for this device; peer average 2.01/device2021-05: 0 reports for this device; peer average 1.9/device2021-06: 0 reports for this device; peer average 1.76/device2021-07: 0 reports for this device; peer average 2.08/device2021-08: 0 reports for this device; peer average 2.23/device2021-09: 0 reports for this device; peer average 1.93/device2021-10: 0 reports for this device; peer average 2.14/device2021-11: 0 reports for this device; peer average 2.06/device2021-12: 0 reports for this device; peer average 2.38/device2022-01: 0 reports for this device; peer average 2.51/device2022-02: 0 reports for this device; peer average 2.37/device2022-03: 0 reports for this device; peer average 2.36/device2022-04: 0 reports for this device; peer average 2.36/device2022-05: 0 reports for this device; peer average 2.05/device2022-06: 0 reports for this device; peer average 2.26/device2022-07: 0 reports for this device; peer average 2.24/device2022-08: 0 reports for this device; peer average 2.19/device2022-09: 0 reports for this device; peer average 2/device2022-10: 0 reports for this device; peer average 2/device2022-11: 0 reports for this device; peer average 2.06/device2022-12: 0 reports for this device; peer average 2.01/device2023-01: 0 reports for this device; peer average 1.82/device2023-02: 0 reports for this device; peer average 1.92/device2023-03: 0 reports for this device; peer average 1.99/device2023-04: 0 reports for this device; peer average 2.11/device2023-05: 0 reports for this device; peer average 2.05/device2023-06: 0 reports for this device; peer average 2.21/device2023-07: 0 reports for this device; peer average 2.05/device2023-08: 0 reports for this device; peer average 1.7/device2023-09: 0 reports for this device; peer average 1.52/device2023-10: 0 reports for this device; peer average 1.6/device2023-11: 0 reports for this device; peer average 1.64/device2023-12: 0 reports for this device; peer average 1.42/device2024-01: 0 reports for this device; peer average 1.77/device2024-02: 0 reports for this device; peer average 1.81/device2024-03: 0 reports for this device; peer average 1.65/device2024-04: 0 reports for this device; peer average 1.84/device2024-05: 0 reports for this device; peer average 1.64/device2024-06: 0 reports for this device; peer average 1.88/device2024-07: 0 reports for this device; peer average 1.57/device2024-08: 0 reports for this device; peer average 1.7/device2024-09: 0 reports for this device; peer average 1.69/device2024-10: 0 reports for this device; peer average 1.7/device2024-11: 0 reports for this device; peer average 1.61/device2024-12: 0 reports for this device; peer average 1.65/device2025-01: 0 reports for this device; peer average 1.71/device2025-02: 0 reports for this device; peer average 1.63/device2025-03: 0 reports for this device; peer average 1.86/device2025-04: 0 reports for this device; peer average 1.75/device2025-05: 0 reports for this device; peer average 1.81/device2025-06: 0 reports for this device; peer average 1.87/device2025-07: 0 reports for this device; peer average 1.71/device2025-08: 0 reports for this device; peer average 1.63/device2025-09: 0 reports for this device; peer average 1.48/device2025-10: 0 reports for this device; peer average 1.62/device2025-11: 0 reports for this device; peer average 1.75/device2025-12: 0 reports for this device; peer average 2.13/device2026-01: 0 reports for this device; peer average 1.86/device2026-02: 0 reports for this device; peer average 1.78/device2026-03: 0 reports for this device; peer average 1.73/device2026-04: 0 reports for this device; peer average 1.72/device2026-05: 0 reports for this device; peer average 1.7/device2026-06: 0 reports for this device; peer average 1.73/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.82
2019-0201.71
2019-0301.67
2019-0401.86
2019-0502.04
2019-0601.86
2019-0701.6
2019-0802.14
2019-0901.65
2019-1001.85
2019-1101.67
2019-1201.77
2020-0101.96
2020-0202.1
2020-0301.99
2020-0401.73
2020-0501.69
2020-0601.99
2020-0702.14
2020-0801.84
2020-0902.01
2020-1002.16
2020-1101.91
2020-1201.85
2021-0102.1
2021-0201.95
2021-0302.09
2021-0402.01
2021-0501.9
2021-0601.76
2021-0702.08
2021-0802.23
2021-0901.93
2021-1002.14
2021-1102.06
2021-1202.38
2022-0102.51
2022-0202.37
2022-0302.36
2022-0402.36
2022-0502.05
2022-0602.26
2022-0702.24
2022-0802.19
2022-0902
2022-1002
2022-1102.06
2022-1202.01
2023-0101.82
2023-0201.92
2023-0301.99
2023-0402.11
2023-0502.05
2023-0602.21
2023-0702.05
2023-0801.7
2023-0901.52
2023-1001.6
2023-1101.64
2023-1201.42
2024-0101.77
2024-0201.81
2024-0301.65
2024-0401.84
2024-0501.64
2024-0601.88
2024-0701.57
2024-0801.7
2024-0901.69
2024-1001.7
2024-1101.61
2024-1201.65
2025-0101.71
2025-0201.63
2025-0301.86
2025-0401.75
2025-0501.81
2025-0601.87
2025-0701.71
2025-0801.63
2025-0901.48
2025-1001.62
2025-1101.75
2025-1202.13
2026-0101.86
2026-0201.78
2026-0301.73
2026-0401.72
2026-0501.7
2026-0601.73
This device (reports/month)Average device in HSD, KWS, KWT, PHX (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