Accolade
Model 6721-0330 · Howmedica Osteonics Corp. · DI 04546540669483
JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented · Class II · 21 CFR 888.3350
KWL — Prosthesis, Hip, Hemi-, Femoral, Metal · Class II · 21 CFR 888.3360
KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented · Class II · 21 CFR 888.3390
KWZ — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer · Class II · 21 CFR 888.3310
LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented · Class II · 21 CFR 888.3358
LWJ — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented · Class II · 21 CFR 888.3360
LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented · Class II · 21 CFR 888.3353
MAY — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish · Class II · 21 CFR 888.3353
MBL — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous · Class II · 21 CFR 888.3358
MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate · Class II · 21 CFR 888.3353
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 (44)
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: 42 · Death: 1 · Malfunction: 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.64 |
| 2019-02 | 2 | 2.27 |
| 2019-03 | 3 | 2.57 |
| 2019-04 | 0 | 2.47 |
| 2019-05 | 1 | 2 |
| 2019-06 | 1 | 1.68 |
| 2019-07 | 0 | 1.71 |
| 2019-08 | 0 | 1.96 |
| 2019-09 | 0 | 2.1 |
| 2019-10 | 0 | 2.28 |
| 2019-11 | 0 | 1.95 |
| 2019-12 | 1 | 2.19 |
| 2020-01 | 0 | 2.48 |
| 2020-02 | 0 | 2.25 |
| 2020-03 | 0 | 2.83 |
| 2020-04 | 3 | 2.01 |
| 2020-05 | 0 | 1.99 |
| 2020-06 | 1 | 1.87 |
| 2020-07 | 0 | 2.3 |
| 2020-08 | 0 | 1.81 |
| 2020-09 | 1 | 2.22 |
| 2020-10 | 0 | 2.23 |
| 2020-11 | 3 | 2.07 |
| 2020-12 | 0 | 2.12 |
| 2021-01 | 0 | 2.22 |
| 2021-02 | 1 | 1.86 |
| 2021-03 | 1 | 1.88 |
| 2021-04 | 0 | 1.87 |
| 2021-05 | 1 | 1.83 |
| 2021-06 | 0 | 2.27 |
| 2021-07 | 0 | 2.13 |
| 2021-08 | 2 | 2.07 |
| 2021-09 | 0 | 2.19 |
| 2021-10 | 0 | 2.04 |
| 2021-11 | 0 | 1.88 |
| 2021-12 | 0 | 2.09 |
| 2022-01 | 1 | 1.88 |
| 2022-02 | 1 | 1.91 |
| 2022-03 | 3 | 1.95 |
| 2022-04 | 0 | 1.97 |
| 2022-05 | 1 | 1.97 |
| 2022-06 | 0 | 2.03 |
| 2022-07 | 0 | 1.92 |
| 2022-08 | 1 | 1.98 |
| 2022-09 | 1 | 2.01 |
| 2022-10 | 0 | 1.96 |
| 2022-11 | 0 | 2.04 |
| 2022-12 | 0 | 1.95 |
| 2023-01 | 0 | 2.09 |
| 2023-02 | 0 | 1.95 |
| 2023-03 | 2 | 2.13 |
| 2023-04 | 1 | 2.07 |
| 2023-05 | 0 | 2.02 |
| 2023-06 | 0 | 2.06 |
| 2023-07 | 2 | 2 |
| 2023-08 | 1 | 1.89 |
| 2023-09 | 0 | 1.9 |
| 2023-10 | 0 | 1.58 |
| 2023-11 | 0 | 1.55 |
| 2023-12 | 0 | 1.64 |
| 2024-01 | 0 | 1.67 |
| 2024-02 | 0 | 1.92 |
| 2024-03 | 1 | 1.89 |
| 2024-04 | 1 | 1.68 |
| 2024-05 | 1 | 2.01 |
| 2024-06 | 0 | 1.84 |
| 2024-07 | 0 | 1.66 |
| 2024-08 | 1 | 1.84 |
| 2024-09 | 1 | 1.93 |
| 2024-10 | 0 | 1.72 |
| 2024-11 | 0 | 1.63 |
| 2024-12 | 0 | 1.52 |
| 2025-01 | 0 | 1.78 |
| 2025-02 | 1 | 1.47 |
| 2025-03 | 0 | 1.76 |
| 2025-04 | 0 | 1.77 |
| 2025-05 | 1 | 1.62 |
| 2025-06 | 0 | 1.76 |
| 2025-07 | 0 | 1.78 |
| 2025-08 | 0 | 1.62 |
| 2025-09 | 0 | 1.67 |
| 2025-10 | 0 | 1.68 |
| 2025-11 | 0 | 1.71 |
| 2025-12 | 0 | 1.8 |
| 2026-01 | 0 | 1.88 |
| 2026-02 | 0 | 1.57 |
| 2026-03 | 0 | 1.85 |
| 2026-04 | 1 | 1.78 |
| 2026-05 | 1 | 1.6 |
| 2026-06 | 0 | 1.68 |
Regulatory clearances
- None linked in the loaded window.
Manufacturer compliance record — Howmedica Osteonics Corp.
- VAI 2023-12-01 Howmedica Osteonics Corp. · 1 citations
- NAI 2021-06-22 Howmedica Osteonics Corp. · 0 citations
- VAI 2015-03-09 Howmedica Osteonics Corp. · 3 citations
- VAI 2013-04-16 Howmedica Osteonics Corp. · 3 citations
- NAI 2010-01-15 Howmedica Osteonics Corp. · 0 citations