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.
107 linked reportsInjury 107
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
1.68
2019-02
2
1.59
2019-03
0
1.68
2019-04
2
1.52
2019-05
2
1.76
2019-06
3
1.87
2019-07
1
1.41
2019-08
2
1.97
2019-09
1
1.48
2019-10
3
1.8
2019-11
0
1.62
2019-12
0
1.74
2020-01
1
1.89
2020-02
2
2.15
2020-03
0
1.76
2020-04
0
1.72
2020-05
0
1.43
2020-06
1
1.8
2020-07
0
1.91
2020-08
0
1.63
2020-09
0
1.92
2020-10
1
2.1
2020-11
0
1.85
2020-12
0
1.82
2021-01
0
1.95
2021-02
0
1.82
2021-03
1
1.98
2021-04
0
1.76
2021-05
0
1.76
2021-06
1
1.63
2021-07
5
1.87
2021-08
1
2.03
2021-09
0
1.66
2021-10
1
1.71
2021-11
4
1.97
2021-12
3
1.93
2022-01
0
2.04
2022-02
2
2.04
2022-03
1
1.73
2022-04
3
2.04
2022-05
2
1.88
2022-06
1
2.01
2022-07
1
2.05
2022-08
3
2
2022-09
3
1.84
2022-10
2
1.87
2022-11
0
2.02
2022-12
0
1.82
2023-01
0
1.72
2023-02
2
1.94
2023-03
0
1.93
2023-04
2
1.92
2023-05
0
2
2023-06
2
2.26
2023-07
0
2.07
2023-08
1
1.67
2023-09
0
1.51
2023-10
2
1.56
2023-11
2
1.61
2023-12
1
1.41
2024-01
4
1.99
2024-02
1
1.76
2024-03
2
1.68
2024-04
2
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
3
1.61
2024-11
2
1.58
2024-12
1
1.63
2025-01
6
1.72
2025-02
0
1.56
2025-03
1
1.84
2025-04
0
1.63
2025-05
1
1.75
2025-06
2
1.83
2025-07
4
1.71
2025-08
0
1.53
2025-09
0
1.51
2025-10
0
1.62
2025-11
1
1.71
2025-12
2
2.11
2026-01
2
1.87
2026-02
0
1.8
2026-03
1
1.75
2026-04
0
1.7
2026-05
3
1.75
2026-06
2
1.68
This device (reports/month)Average device in KWS (reports/device/month)
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
Initiated
Recall #
Class
Status
Reason
Quantity
Link basis
2026-01-15
Z-1458-2026
Class II
Open, Classified
Knee and Humeral socket implants contain incorrect labeling.Distribution: US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.
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.