Adverse-event reports (MAUDE)
Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
18 linked reportsInjury 18
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.68 |
| 2019-02 | 0 | 1.59 |
| 2019-03 | 2 | 1.68 |
| 2019-04 | 0 | 1.52 |
| 2019-05 | 0 | 1.76 |
| 2019-06 | 0 | 1.87 |
| 2019-07 | 0 | 1.41 |
| 2019-08 | 1 | 1.97 |
| 2019-09 | 0 | 1.48 |
| 2019-10 | 0 | 1.8 |
| 2019-11 | 1 | 1.62 |
| 2019-12 | 0 | 1.74 |
| 2020-01 | 0 | 1.89 |
| 2020-02 | 0 | 2.15 |
| 2020-03 | 0 | 1.76 |
| 2020-04 | 0 | 1.72 |
| 2020-05 | 1 | 1.43 |
| 2020-06 | 0 | 1.8 |
| 2020-07 | 0 | 1.91 |
| 2020-08 | 0 | 1.63 |
| 2020-09 | 0 | 1.92 |
| 2020-10 | 0 | 2.1 |
| 2020-11 | 0 | 1.85 |
| 2020-12 | 0 | 1.82 |
| 2021-01 | 0 | 1.95 |
| 2021-02 | 0 | 1.82 |
| 2021-03 | 0 | 1.98 |
| 2021-04 | 0 | 1.76 |
| 2021-05 | 0 | 1.76 |
| 2021-06 | 1 | 1.63 |
| 2021-07 | 0 | 1.87 |
| 2021-08 | 0 | 2.03 |
| 2021-09 | 1 | 1.66 |
| 2021-10 | 0 | 1.71 |
| 2021-11 | 0 | 1.97 |
| 2021-12 | 0 | 1.93 |
| 2022-01 | 0 | 2.04 |
| 2022-02 | 0 | 2.04 |
| 2022-03 | 0 | 1.73 |
| 2022-04 | 0 | 2.04 |
| 2022-05 | 0 | 1.88 |
| 2022-06 | 0 | 2.01 |
| 2022-07 | 0 | 2.05 |
| 2022-08 | 0 | 2 |
| 2022-09 | 0 | 1.84 |
| 2022-10 | 0 | 1.87 |
| 2022-11 | 1 | 2.02 |
| 2022-12 | 0 | 1.82 |
| 2023-01 | 0 | 1.72 |
| 2023-02 | 0 | 1.94 |
| 2023-03 | 0 | 1.93 |
| 2023-04 | 0 | 1.92 |
| 2023-05 | 0 | 2 |
| 2023-06 | 2 | 2.26 |
| 2023-07 | 0 | 2.07 |
| 2023-08 | 0 | 1.67 |
| 2023-09 | 0 | 1.51 |
| 2023-10 | 0 | 1.56 |
| 2023-11 | 1 | 1.61 |
| 2023-12 | 0 | 1.41 |
| 2024-01 | 0 | 1.99 |
| 2024-02 | 0 | 1.76 |
| 2024-03 | 1 | 1.68 |
| 2024-04 | 1 | 1.77 |
| 2024-05 | 0 | 1.72 |
| 2024-06 | 0 | 1.9 |
| 2024-07 | 0 | 1.6 |
| 2024-08 | 0 | 1.7 |
| 2024-09 | 0 | 1.71 |
| 2024-10 | 1 | 1.61 |
| 2024-11 | 0 | 1.58 |
| 2024-12 | 0 | 1.63 |
| 2025-01 | 0 | 1.72 |
| 2025-02 | 0 | 1.56 |
| 2025-03 | 0 | 1.84 |
| 2025-04 | 0 | 1.63 |
| 2025-05 | 0 | 1.75 |
| 2025-06 | 2 | 1.83 |
| 2025-07 | 0 | 1.71 |
| 2025-08 | 0 | 1.53 |
| 2025-09 | 0 | 1.51 |
| 2025-10 | 0 | 1.62 |
| 2025-11 | 0 | 1.71 |
| 2025-12 | 0 | 2.11 |
| 2026-01 | 0 | 1.87 |
| 2026-02 | 1 | 1.8 |
| 2026-03 | 0 | 1.75 |
| 2026-04 | 0 | 1.7 |
| 2026-05 | 1 | 1.75 |
| 2026-06 | 0 | 1.68 |
Failure-mode summaryAI-generated
18 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2020-08-07 | Z-3022-2020 | Class II | Open, Classified | Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting the incorrect size; significant physical impairment, discomfort and/or disruption of treatment of underlying condition; and the patient experiencing dislocation resulting in revision surgery.Distribution: Distributed in the U.S. to: VA, MN, IN, RI, PA, NY, WA, KS, OK, FL, GA and CA | 37 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-05-26 | 1644408-2026-00980 | Injury | Available | exact di |
| 2026-02-10 | 1644408-2026-00238 | Injury | Available | exact di |
| 2025-06-20 | 1644408-2025-00851 | Injury | Available | exact di |
| 2025-06-20 | 1644408-2025-00850 | Injury | Available | exact di |
| 2024-10-10 | 1644408-2024-01547 | Injury | Available | exact di |
| 2024-04-24 | 1644408-2024-00560 | Injury | Available | exact di |
| 2024-03-01 | 1644408-2024-00223 | Injury | Available | exact di |
| 2023-11-30 | 1644408-2023-01758 | Injury | Available | exact di |
| 2023-06-12 | 1644408-2023-00740 | Injury | Available | exact di |
| 2022-11-29 | 1644408-2022-01570 | Injury | Available | exact di |
| 2021-09-09 | 1644408-2021-00964 | Injury | Available | exact di |
| 2021-06-02 | 1644408-2021-00479 | Injury | Available | exact di |
| 2020-05-06 | 1644408-2020-00369 | Injury | Available | exact di |
| 2019-11-02 | 1644408-2019-01062 | Injury | Available | exact di |
| 2019-08-01 | 1644408-2019-00702 | Injury | Available | exact di |
Showing the most recent 16 of 18 linked reports.
Showing 1–15 of 16
Regulatory clearances
Predicate lineage
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2021-10-28 | VAI | Voluntary action indicated | Encore Medical, LP | 2 |
| 2020-03-11 | NAI | No action indicated | Encore Medical, LP | 0 |
| 2015-07-24 | NAI | No action indicated | Encore Medical, LP | 0 |
| 2013-06-28 | VAI | Voluntary action indicated | Encore Medical, LP | 2 |
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