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ACCLAIM

Model 1722-91-000 · DEPUY ORTHOPAEDICS, INC. · DI 10603295067665

JDB — Prosthesis, Elbow, Semi-Constrained, Cemented · Class II · 21 CFR 888.3160

UDILibrary device dossier · generated 2026-09-13 · 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.

12342019-01: 0 reports for this device; peer average 1.5/device2019-02: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 1/device2019-06: 0 reports for this device; peer average 1.33/device2019-08: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 1.67/device2020-01: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 3/device2020-04: 0 reports for this device; peer average 3/device2020-06: 0 reports for this device; peer average 2.17/device2020-07: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 1/device2020-10: 0 reports for this device; peer average 1/device2020-11: 0 reports for this device; peer average 1.4/device2021-01: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 1/device2021-07: 0 reports for this device; peer average 3/device2021-08: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 2.38/device2022-01: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 1.5/device2022-03: 0 reports for this device; peer average 3/device2022-04: 0 reports for this device; peer average 3/device2022-05: 0 reports for this device; peer average 3/device2022-06: 0 reports for this device; peer average 3/device2022-07: 0 reports for this device; peer average 2/device2022-08: 0 reports for this device; peer average 2.33/device2022-09: 0 reports for this device; peer average 3/device2022-10: 0 reports for this device; peer average 2/device2022-11: 0 reports for this device; peer average 2.4/device2022-12: 0 reports for this device; peer average 2/device2023-01: 0 reports for this device; peer average 3/device2023-03: 0 reports for this device; peer average 3.25/device2023-04: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 1/device2023-06: 0 reports for this device; peer average 3/device2023-07: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 1.63/device2023-11: 0 reports for this device; peer average 1.5/device2023-12: 0 reports for this device; peer average 1.5/device2024-01: 0 reports for this device; peer average 2.71/device2024-03: 0 reports for this device; peer average 1.6/device2024-04: 0 reports for this device; peer average 1.67/device2024-05: 0 reports for this device; peer average 1.33/device2024-06: 0 reports for this device; peer average 2.63/device2024-07: 0 reports for this device; peer average 1.67/device2024-08: 0 reports for this device; peer average 2.57/device2024-09: 0 reports for this device; peer average 4.12/device2024-10: 0 reports for this device; peer average 1.91/device2024-11: 0 reports for this device; peer average 1.9/device2025-01: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 2/device2025-08: 0 reports for this device; peer average 1.25/device2025-10: 0 reports for this device; peer average 2.5/device2025-11: 0 reports for this device; peer average 2/device2025-12: 0 reports for this device; peer average 1.75/device2026-01: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 1.86/device2026-04: 0 reports for this device; peer average 1.8/device2026-05: 0 reports for this device; peer average 1.83/device010203040506081012010204060709101101060708091112010203040506070809101112010304050607080910111201030405060708091011010405070810111201030405
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.5
2019-0201
2019-0301
2019-0401
2019-0501
2019-0601.33
2019-0801
2019-1001
2019-1201.67
2020-0101
2020-0203
2020-0403
2020-0602.17
2020-0701
2020-0901
2020-1001
2020-1101.4
2021-0101
2021-0601
2021-0703
2021-0801
2021-0901
2021-1101
2021-1202.38
2022-0101
2022-0201.5
2022-0303
2022-0403
2022-0503
2022-0603
2022-0702
2022-0802.33
2022-0903
2022-1002
2022-1102.4
2022-1202
2023-0103
2023-0303.25
2023-0401
2023-0501
2023-0603
2023-0702
2023-0801
2023-0902
2023-1001.63
2023-1101.5
2023-1201.5
2024-0102.71
2024-0301.6
2024-0401.67
2024-0501.33
2024-0602.63
2024-0701.67
2024-0802.57
2024-0904.12
2024-1001.91
2024-1101.9
2025-0102
2025-0401
2025-0501
2025-0702
2025-0801.25
2025-1002.5
2025-1102
2025-1201.75
2026-0101
2026-0301.86
2026-0401.8
2026-0501.83
This device (reports/month)Average device in JDB (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — DEPUY ORTHOPAEDICS, INC.

  • Warning Letter 2011-12-08 DePuy Orthopaedics, Inc.
  • Warning Letter 2010-08-19 DePuy Orthopaedics, Inc.
  • NAI 2024-03-28 DePuy Orthopaedics, Inc. · 0 citations
  • NAI 2022-05-12 DePuy Orthopaedics, Inc. · 0 citations
  • NAI 2019-11-08 DePuy Orthopaedics, Inc. · 0 citations
  • VAI 2017-09-01 DePuy Orthopaedics, Inc. · 2 citations
  • VAI 2015-10-01 DePuy Orthopaedics, Inc. · 2 citations
  • NAI 2015-09-24 DePuy Orthopaedics, Inc. · 0 citations
  • VAI 2012-11-26 DePuy Orthopaedics, Inc. · 6 citations
  • NAI 2011-08-16 DePuy Orthopaedics, Inc. · 0 citations
  • OAI 2011-06-07 DePuy Orthopaedics, Inc. · 6 citations