GMK Primary Total Knee System · recalls, adverse events, clearances

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.

79 linked reportsInjury 79

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-01	1	2.03
2019-02	1	2.07
2019-03	0	1.68
2019-04	0	2.01
2019-05	0	1.83
2019-06	0	2.19
2019-07	1	2.04
2019-08	1	2.24
2019-09	1	2.01
2019-10	1	2.44
2019-11	0	3.01
2019-12	1	2.42
2020-01	1	2.39
2020-02	0	2.82
2020-03	0	2.28
2020-04	0	2.21
2020-05	0	1.83
2020-06	0	2.09
2020-07	2	2.66
2020-08	0	2.72
2020-09	2	2.23
2020-10	2	2.94
2020-11	0	2.86
2020-12	0	2.95
2021-01	0	2.47
2021-02	2	2.45
2021-03	0	2.59
2021-04	2	2.45
2021-05	2	2.36
2021-06	0	2.18
2021-07	2	2.24
2021-08	0	1.88
2021-09	0	2.33
2021-10	0	1.96
2021-11	0	2.31
2021-12	2	2.33
2022-01	0	2.03
2022-02	0	2.38
2022-03	0	2.05
2022-04	6	2.1
2022-05	4	2.33
2022-06	0	2.03
2022-07	2	2.06
2022-08	4	2.1
2022-09	0	2.28
2022-10	2	2.2
2022-11	0	2.24
2022-12	0	1.9
2023-01	2	2.09
2023-02	0	2.23
2023-03	2	2.23
2023-04	0	2.26
2023-05	0	2.41
2023-06	2	2.26
2023-07	2	2
2023-08	0	1.71
2023-09	1	1.76
2023-10	0	1.63
2023-11	1	1.68
2023-12	0	1.7
2024-01	0	1.57
2024-02	0	1.74
2024-03	0	1.78
2024-04	0	1.64
2024-05	0	1.91
2024-06	0	1.98
2024-07	1	1.85
2024-08	0	2.31
2024-09	1	2
2024-10	2	1.99
2024-11	0	2
2024-12	1	2.09
2025-01	0	2.32
2025-02	2	1.83
2025-03	4	1.86
2025-04	0	1.66
2025-05	4	1.71
2025-06	2	1.81
2025-07	0	1.62
2025-08	2	1.63
2025-09	0	1.64
2025-10	2	1.43
2025-11	0	1.7
2025-12	4	1.66
2026-01	0	1.55
2026-02	0	1.53
2026-03	0	1.99
2026-04	0	1.75
2026-05	2	1.71
2026-06	0	1.7

This device (reports/month)Average device in JWH (reports/device/month)

Failure-mode summaryAI-generated

40 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2026-05-05	3005180920-2026-00360	Injury	Available	exact di
2025-12-23	3005180920-2025-01309	Injury	Available	exact di
2025-12-20	3005180920-2025-01275	Injury	Available	exact di
2025-10-16	3005180920-2025-01019	Injury	Available	exact di
2025-08-06	3005180920-2025-00766	Injury	Available	exact di
2025-06-25	3005180920-2025-00602	Injury	Available	exact di
2025-05-30	3005180920-2025-00484	Injury	Available	exact di
2025-05-28	3005180920-2025-00459	Injury	Available	exact di
2025-03-27	3005180920-2025-00238	Injury	Available	exact di
2025-03-21	3005180920-2025-00201	Injury	Available	exact di
2025-02-05	3005180920-2025-00057	Injury	Available	exact di
2024-12-20	3005180920-2024-01091	Injury	Available	model number
2024-10-08	3005180920-2024-00811	Injury	Available	exact di
2024-09-16	3005180920-2024-00753	Injury	Available	exact di
2024-07-16	3005180920-2024-00530	Injury	Available	exact di

Showing the most recent 46 of 79 linked reports.

Showing 1–15 of 46

Regulatory clearances

Predicate lineage

K090988

Cited as predicate by: K093806, K100314, K102437, K103170, K111283, K113571, K120790, K121416, K122232, K123721, K131310, K133630, K140826, K142069, K162035, K170106, K170149, K181635, K200122, K202022, K211004, K213071, K221850, K234044

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
2024-11-19	VAI	Voluntary action indicated	Medacta International, SA	1
2024-11-19	VAI	Voluntary action indicated	Medacta International SA	0
2024-11-19	VAI	Voluntary action indicated	Medacta International, SA	1
2024-11-19	VAI	Voluntary action indicated	Medacta International SA	0
2017-06-19	VAI	Voluntary action indicated	Medacta International SA	0
2017-06-19	VAI	Voluntary action indicated	Medacta International SA	0
2017-02-17	VAI	Voluntary action indicated	Parcus Medical, LLC	2
2015-02-05	OAI	Official action indicated	Medacta International SA	8
2015-02-05	OAI	Official action indicated	Medacta International SA	8
2013-08-16	VAI	Voluntary action indicated	Parcus Medical, LLC	1
2010-01-28	VAI	Voluntary action indicated	Medacta International SA	0
2010-01-28	VAI	Voluntary action indicated	Medacta International SA	0

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