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REDAPT

Model 71355445 · Smith & Nephew, Inc. · DI 00885556584484

LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented · Class II · 21 CFR 888.3353

MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate · Class II · 21 CFR 888.3353

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 (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 2.38/device2019-02: 0 reports for this device; peer average 2.17/device2019-03: 0 reports for this device; peer average 2.44/device2019-04: 0 reports for this device; peer average 2.41/device2019-05: 0 reports for this device; peer average 1.91/device2019-06: 0 reports for this device; peer average 1.68/device2019-07: 0 reports for this device; peer average 1.62/device2019-08: 0 reports for this device; peer average 2/device2019-09: 0 reports for this device; peer average 1.95/device2019-10: 0 reports for this device; peer average 2.18/device2019-11: 0 reports for this device; peer average 2.02/device2019-12: 0 reports for this device; peer average 2.22/device2020-01: 0 reports for this device; peer average 2.6/device2020-02: 0 reports for this device; peer average 2.2/device2020-03: 0 reports for this device; peer average 2.76/device2020-04: 0 reports for this device; peer average 2.1/device2020-05: 0 reports for this device; peer average 1.96/device2020-06: 0 reports for this device; peer average 1.9/device2020-07: 0 reports for this device; peer average 2.35/device2020-08: 0 reports for this device; peer average 1.97/device2020-09: 0 reports for this device; peer average 2.43/device2020-10: 0 reports for this device; peer average 2.38/device2020-11: 0 reports for this device; peer average 2.11/device2020-12: 0 reports for this device; peer average 2.16/device2021-01: 0 reports for this device; peer average 2.24/device2021-02: 0 reports for this device; peer average 1.96/device2021-03: 0 reports for this device; peer average 1.94/device2021-04: 0 reports for this device; peer average 1.96/device2021-05: 0 reports for this device; peer average 1.97/device2021-06: 0 reports for this device; peer average 2.23/device2021-07: 0 reports for this device; peer average 2.25/device2021-08: 0 reports for this device; peer average 2.21/device2021-09: 0 reports for this device; peer average 2.45/device2021-10: 0 reports for this device; peer average 2.19/device2021-11: 0 reports for this device; peer average 1.98/device2021-12: 0 reports for this device; peer average 2.12/device2022-01: 0 reports for this device; peer average 2.01/device2022-02: 0 reports for this device; peer average 2.06/device2022-03: 0 reports for this device; peer average 2.07/device2022-04: 0 reports for this device; peer average 2.05/device2022-05: 0 reports for this device; peer average 2.19/device2022-06: 0 reports for this device; peer average 2.09/device2022-07: 0 reports for this device; peer average 2.05/device2022-08: 0 reports for this device; peer average 2.11/device2022-09: 0 reports for this device; peer average 2.2/device2022-10: 0 reports for this device; peer average 2.13/device2022-11: 0 reports for this device; peer average 2.22/device2022-12: 0 reports for this device; peer average 2.07/device2023-01: 0 reports for this device; peer average 2.26/device2023-02: 0 reports for this device; peer average 2.08/device2023-03: 0 reports for this device; peer average 2.19/device2023-04: 0 reports for this device; peer average 2.24/device2023-05: 0 reports for this device; peer average 2.13/device2023-06: 0 reports for this device; peer average 2.26/device2023-07: 0 reports for this device; peer average 2.16/device2023-08: 0 reports for this device; peer average 1.92/device2023-09: 0 reports for this device; peer average 1.97/device2023-10: 0 reports for this device; peer average 1.67/device2023-11: 0 reports for this device; peer average 1.64/device2023-12: 0 reports for this device; peer average 1.74/device2024-01: 0 reports for this device; peer average 1.72/device2024-02: 0 reports for this device; peer average 2.06/device2024-03: 0 reports for this device; peer average 1.97/device2024-04: 0 reports for this device; peer average 1.82/device2024-05: 0 reports for this device; peer average 2.22/device2024-06: 0 reports for this device; peer average 1.97/device2024-07: 0 reports for this device; peer average 1.71/device2024-08: 0 reports for this device; peer average 2.03/device2024-09: 0 reports for this device; peer average 1.97/device2024-10: 0 reports for this device; peer average 1.81/device2024-11: 0 reports for this device; peer average 1.79/device2024-12: 0 reports for this device; peer average 1.62/device2025-01: 0 reports for this device; peer average 1.99/device2025-02: 0 reports for this device; peer average 1.58/device2025-03: 0 reports for this device; peer average 1.8/device2025-04: 0 reports for this device; peer average 1.84/device2025-05: 0 reports for this device; peer average 1.78/device2025-06: 0 reports for this device; peer average 1.87/device2025-07: 0 reports for this device; peer average 1.81/device2025-08: 0 reports for this device; peer average 1.78/device2025-09: 0 reports for this device; peer average 1.67/device2025-10: 0 reports for this device; peer average 1.72/device2025-11: 0 reports for this device; peer average 1.8/device2025-12: 0 reports for this device; peer average 1.92/device2026-01: 0 reports for this device; peer average 1.92/device2026-02: 0 reports for this device; peer average 1.72/device2026-03: 0 reports for this device; peer average 1.95/device2026-04: 0 reports for this device; peer average 1.97/device2026-05: 0 reports for this device; peer average 1.76/device2026-06: 0 reports for this device; peer average 1.8/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.38
2019-0202.17
2019-0302.44
2019-0402.41
2019-0501.91
2019-0601.68
2019-0701.62
2019-0802
2019-0901.95
2019-1002.18
2019-1102.02
2019-1202.22
2020-0102.6
2020-0202.2
2020-0302.76
2020-0402.1
2020-0501.96
2020-0601.9
2020-0702.35
2020-0801.97
2020-0902.43
2020-1002.38
2020-1102.11
2020-1202.16
2021-0102.24
2021-0201.96
2021-0301.94
2021-0401.96
2021-0501.97
2021-0602.23
2021-0702.25
2021-0802.21
2021-0902.45
2021-1002.19
2021-1101.98
2021-1202.12
2022-0102.01
2022-0202.06
2022-0302.07
2022-0402.05
2022-0502.19
2022-0602.09
2022-0702.05
2022-0802.11
2022-0902.2
2022-1002.13
2022-1102.22
2022-1202.07
2023-0102.26
2023-0202.08
2023-0302.19
2023-0402.24
2023-0502.13
2023-0602.26
2023-0702.16
2023-0801.92
2023-0901.97
2023-1001.67
2023-1101.64
2023-1201.74
2024-0101.72
2024-0202.06
2024-0301.97
2024-0401.82
2024-0502.22
2024-0601.97
2024-0701.71
2024-0802.03
2024-0901.97
2024-1001.81
2024-1101.79
2024-1201.62
2025-0101.99
2025-0201.58
2025-0301.8
2025-0401.84
2025-0501.78
2025-0601.87
2025-0701.81
2025-0801.78
2025-0901.67
2025-1001.72
2025-1101.8
2025-1201.92
2026-0101.92
2026-0201.72
2026-0301.95
2026-0401.97
2026-0501.76
2026-0601.8
This device (reports/month)Average device in LZO, MEH (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K151902 — cites (transitively): K113789 (d1), K121627 (d1), K081124 (d2) — cited as predicate by K162303, K211176, K212815, K243021

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

Manufacturer compliance record — Smith & Nephew, Inc.

  • Warning Letter 2015-04-30 Smith & Nephew Inc.
  • Warning Letter 2015-04-30 Smith & Nephew Inc.
  • Warning Letter 2014-06-11 Smith & Nephew, Inc.
  • Warning Letter 2010-09-16 Ascension Orthopedics, Inc
  • NAI 2025-01-27 Integrity Orthopaedics Inc · 0 citations
  • NAI 2023-05-03 CARTIHEAL, LTD · 0 citations
  • VAI 2021-12-09 Smith & Nephew, Inc. · 1 citations
  • VAI 2021-12-09 Smith & Nephew, Inc. · 1 citations
  • NAI 2021-10-26 Smith & Nephew Inc. · 0 citations
  • NAI 2021-10-26 Smith & Nephew Inc. · 0 citations
  • VAI 2020-02-06 Blue Belt Technologies, Inc · 6 citations
  • NAI 2019-10-25 Tusker Medical, Inc. · 0 citations
  • VAI 2019-10-08 Tusker Medical, Inc. · 3 citations
  • NAI 2018-03-30 Ascension Orthopedics, Inc · 0 citations
  • NAI 2018-02-02 Smith & Nephew, Inc. · 0 citations
  • NAI 2018-02-02 Smith & Nephew, Inc. · 0 citations
  • NAI 2018-01-30 Smith & Nephew · 0 citations
  • NAI 2017-08-21 Smith & Nephew, Inc. Advanced Surgical Devices Division · 0 citations
  • VAI 2017-08-02 Smith & Nephew, Inc. · 3 citations
  • VAI 2017-08-02 Smith & Nephew, Inc. · 3 citations
  • NAI 2017-07-24 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-07-24 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-05-25 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-05-25 Smith & Nephew, Inc. · 0 citations