Oxford Partial 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.

34 linked reportsInjury 32Malfunction 2

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	1.9
2019-02	2	1.67
2019-03	1	1.12
2019-04	0	1.52
2019-05	0	1.23
2019-06	1	1.89
2019-07	1	2.52
2019-08	0	2
2019-09	0	2.33
2019-10	1	1.37
2019-11	0	1.77
2019-12	0	2.13
2020-01	0	1.5
2020-02	0	1.5
2020-03	2	1.82
2020-04	0	1.73
2020-05	0	1.67
2020-06	0	1.82
2020-07	0	2.14
2020-08	0	1.55
2020-09	2	1.93
2020-10	0	1.78
2020-11	0	1.3
2020-12	4	2.29
2021-01	1	2
2021-02	0	1.25
2021-03	0	1.38
2021-04	0	1.55
2021-05	1	2.31
2021-06	0	1.85
2021-07	0	2.29
2021-08	0	1.8
2021-09	2	1.84
2021-10	2	1.9
2021-11	2	2.11
2021-12	0	1.63
2022-01	0	2.29
2022-02	0	2.27
2022-03	0	1.6
2022-04	0	1.85
2022-05	0	2
2022-06	0	2.53
2022-07	0	2.23
2022-08	2	2.1
2022-09	0	2.2
2022-10	0	2.29
2022-11	0	2
2022-12	0	2
2023-01	0	2.36
2023-02	2	2.78
2023-03	0	1.92
2023-04	0	3.92
2023-05	0	3
2023-06	0	2.23
2023-07	0	2.19
2023-08	0	2.5
2023-09	0	2.17
2023-10	0	2.1
2023-11	0	2.67
2023-12	0	2.63
2024-01	0	1.71
2024-02	0	1.19
2024-03	0	2.22
2024-04	0	2.33
2024-05	0	1.92
2024-06	0	2.75
2024-07	0	2.33
2024-08	0	2.08
2024-09	0	2
2024-10	2	1.78
2024-11	2	2.44
2024-12	0	1.8
2025-01	0	2.2
2025-02	0	2.25
2025-03	0	1.89
2025-04	0	1.38
2025-05	1	1.56
2025-06	0	1.83
2025-07	0	2.08
2025-08	0	1.67
2025-09	0	1.4
2025-10	0	2.2
2025-11	0	2
2025-12	0	2.9
2026-01	0	2.38
2026-02	0	2.71
2026-03	2	2
2026-04	1	3.36
2026-05	0	1.67
2026-06	0	1.83

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

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2026-04-07	3002806535-2026-00137	Injury	Available	catalog number
2026-03-02	3002806535-2026-00101	Malfunction	Available	catalog number
2025-05-20	3002806535-2025-00202	Injury	Available	catalog number
2024-11-25	3002806535-2024-00432	Injury	Available	catalog number
2024-10-28	3002806535-2024-00407	Injury	Available	catalog number
2023-02-13	3002806535-2023-00022	Injury	Available	catalog number
2022-08-19	3002806535-2022-00360	Injury	Available	catalog number
2021-11-15	3002806535-2021-00495	Injury	Available	catalog number
2021-10-21	3002806535-2021-00454	Injury	Available	catalog number
2021-09-01	3002806535-2021-00372	Injury	Available	catalog number
2021-05-21	3002806535-2021-00212	Injury	Available	catalog number
2021-01-04	3002806535-2021-00003	Injury	Available	catalog number
2020-12-15	3002806535-2020-00535	Injury	Available	catalog number
2020-12-01	3002806535-2020-00508	Injury	Available	catalog number
2020-09-17	3002806535-2020-00417	Injury	Available	catalog number

Showing the most recent 22 of 34 linked reports.

Showing 1–15 of 22

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2017-08-03	VAI	Voluntary action indicated	Biomet UK Ltd.	4
2015-03-18	VAI	Voluntary action indicated	Biomet UK Ltd.	2

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