PERSONA™ · 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.

78 linked reportsMalfunction 77Injury 1

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	2.03
2019-02	0	2.07
2019-03	0	1.68
2019-04	0	2.01
2019-05	0	1.83
2019-06	0	2.19
2019-07	0	2.04
2019-08	0	2.24
2019-09	0	2.01
2019-10	0	2.44
2019-11	0	3.01
2019-12	0	2.42
2020-01	0	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	0	2.66
2020-08	0	2.72
2020-09	0	2.23
2020-10	0	2.94
2020-11	0	2.86
2020-12	0	2.95
2021-01	0	2.47
2021-02	0	2.45
2021-03	2	2.59
2021-04	0	2.45
2021-05	0	2.36
2021-06	1	2.18
2021-07	0	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	1	2.05
2022-04	4	2.1
2022-05	1	2.33
2022-06	1	2.03
2022-07	0	2.06
2022-08	0	2.1
2022-09	0	2.28
2022-10	2	2.2
2022-11	1	2.24
2022-12	0	1.9
2023-01	0	2.09
2023-02	4	2.23
2023-03	2	2.23
2023-04	3	2.26
2023-05	3	2.41
2023-06	0	2.26
2023-07	0	2
2023-08	1	1.71
2023-09	0	1.76
2023-10	4	1.63
2023-11	3	1.68
2023-12	3	1.7
2024-01	2	1.57
2024-02	0	1.74
2024-03	1	1.78
2024-04	1	1.64
2024-05	2	1.91
2024-06	1	1.98
2024-07	1	1.85
2024-08	2	2.31
2024-09	2	2
2024-10	1	1.99
2024-11	2	2
2024-12	0	2.09
2025-01	0	2.32
2025-02	1	1.83
2025-03	3	1.86
2025-04	2	1.66
2025-05	0	1.71
2025-06	4	1.81
2025-07	1	1.62
2025-08	2	1.63
2025-09	2	1.64
2025-10	1	1.43
2025-11	0	1.7
2025-12	1	1.66
2026-01	0	1.55
2026-02	0	1.53
2026-03	4	1.99
2026-04	1	1.75
2026-05	1	1.71
2026-06	2	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
2026-06-18	0001822565-2026-01970	Malfunction	Available	exact di
2026-06-08	0001822565-2026-01821	Malfunction	Available	exact di
2026-05-04	0001822565-2026-01449	Malfunction	Available	exact di
2026-04-28	0001822565-2026-01405	Malfunction	Available	exact di
2026-03-31	0001822565-2026-01004	Malfunction	Available	exact di
2026-03-20	0001822565-2026-00868	Malfunction	Available	exact di
2026-03-18	0001822565-2026-00833	Malfunction	Available	exact di
2026-03-04	0001822565-2026-00716	Malfunction	Available	exact di
2025-12-30	0001822565-2025-04896	Malfunction	Available	exact di
2025-10-15	0001822565-2025-03731	Malfunction	Available	exact di
2025-09-11	0001822565-2025-03372	Malfunction	Available	exact di
2025-09-03	0001822565-2025-03240	Malfunction	Available	exact di
2025-08-11	0001822565-2025-02868	Malfunction	Available	exact di
2025-08-04	0001822565-2025-02767	Malfunction	Available	exact di
2025-07-01	0001822565-2025-02275	Malfunction	Available	exact di

Showing 1–15 of 78

Regulatory clearances

Predicate lineage

K113369

Cited as predicate by: K123692, K140027, K140833, K142787, K161592, K172524, K181947, K193223, K200209, K212129, K221479, K230078, K230321

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
2022-07-27	NAI	No action indicated	Zimmer, Inc.	0
2022-07-27	NAI	No action indicated	Zimmer, Inc.	0
2020-10-01	NAI	No action indicated	Zimmer Manufacturing B.V.	0
2017-10-16	VAI	Voluntary action indicated	Zimmer, Inc.	8
2017-10-16	VAI	Voluntary action indicated	Zimmer, Inc.	8
2017-09-01	NAI	No action indicated	Zimmer Trabecular Metal Technology, Inc.	0
2017-07-27	VAI	Voluntary action indicated	ZIMMER ORTHOPEDIC MFG LTD	3
2017-07-20	VAI	Voluntary action indicated	Zimmer Manufacturing B.V.	3
2016-05-27	WL	Warning Letter	Orthosoft, Inc.	—
2016-05-23	VAI	Voluntary action indicated	Zimmer Surgical Inc	4
2015-11-20	OAI	Official action indicated	Zimmer, Inc.	10
2015-11-20	OAI	Official action indicated	Zimmer, Inc.	10
2015-11-17	VAI	Voluntary action indicated	Zimmer Manufacturing B.V.	4
2015-05-11	VAI	Voluntary action indicated	Zimmer Trabecular Metal Technology, Inc.	3
2014-10-16	VAI	Voluntary action indicated	ZIMMER ORTHOPEDIC MFG LTD	2
2014-06-11	OAI	Official action indicated	Zimmer Manufacturing B.V.	9
2014-05-28	OAI	Official action indicated	Zimmer, Inc.	12
2014-05-28	OAI	Official action indicated	Zimmer, Inc.	12
2014-02-07	VAI	Voluntary action indicated	Zimmer, Inc.	2
2014-02-07	VAI	Voluntary action indicated	Zimmer, Inc.	2
2013-08-19	OAI	Official action indicated	Zimmer, Inc.	0
2012-09-19	WL	Warning Letter	Zimmer Manufacturing B.V.	—

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