Print-ready dossier — use your browser's print dialog to save as PDF.
Unnamed device
Model 6250-65-25 · Zimmer, Inc. · DI 00889024119819
LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented · Class II · 21 CFR 888.3358
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 (78)
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.
Injury: 63 · Malfunction: 15
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
3.78
2019-02
0
3.22
2019-03
0
3.68
2019-04
0
3.37
2019-05
0
2.54
2019-06
0
2.14
2019-07
0
2.2
2019-08
0
2.5
2019-09
1
3.06
2019-10
0
3.39
2019-11
0
2.71
2019-12
0
3.06
2020-01
0
3.49
2020-02
0
3.08
2020-03
0
3.94
2020-04
2
2.72
2020-05
0
2.59
2020-06
0
2.56
2020-07
1
3.01
2020-08
2
2.39
2020-09
0
3.09
2020-10
0
3.06
2020-11
0
2.85
2020-12
0
2.78
2021-01
0
3.04
2021-02
0
2.39
2021-03
0
2.43
2021-04
0
2.53
2021-05
0
2.28
2021-06
0
3.08
2021-07
1
2.72
2021-08
0
2.84
2021-09
0
2.8
2021-10
0
2.5
2021-11
1
2.47
2021-12
0
2.77
2022-01
3
2.46
2022-02
0
2.17
2022-03
0
2.71
2022-04
1
2.5
2022-05
2
2.37
2022-06
0
2.76
2022-07
1
2.4
2022-08
1
2.53
2022-09
0
2.5
2022-10
2
2.48
2022-11
1
2.57
2022-12
1
2.64
2023-01
2
2.67
2023-02
0
2.6
2023-03
0
2.99
2023-04
0
2.72
2023-05
0
2.56
2023-06
1
2.62
2023-07
1
2.34
2023-08
0
2.21
2023-09
4
2.15
2023-10
2
1.93
2023-11
0
1.8
2023-12
4
1.93
2024-01
1
1.94
2024-02
0
2.35
2024-03
3
2.12
2024-04
0
1.94
2024-05
1
2.16
2024-06
1
2.08
2024-07
0
1.91
2024-08
1
1.98
2024-09
2
2.33
2024-10
5
2.02
2024-11
0
2.02
2024-12
1
1.67
2025-01
2
2.17
2025-02
3
1.65
2025-03
0
1.91
2025-04
5
1.91
2025-05
4
1.93
2025-06
3
1.97
2025-07
0
2
2025-08
4
1.86
2025-09
1
1.89
2025-10
1
1.81
2025-11
2
1.86
2025-12
0
2
2026-01
2
2.09
2026-02
1
1.73
2026-03
0
2.03
2026-04
1
1.95
2026-05
0
1.73
2026-06
0
1.86
This device (reports/month)Average device in LPH (reports/device/month)
Regulatory clearances
None linked in the loaded window.
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